Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): A Multi-center Comparative Effectiveness Trial of In-home Gamified Constraint-induced Movement Therapy for Rehabilitation of Chronic Upper Extremity Hemiparesis.
Phase: NA
Conditions: Stroke, Hemiparesis
Sponsor: Ohio State University

 
 
 
1
RESEARCH PROTOCOL 
 
 
Title: Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper 
Extremity Rehabilitation 
 
Clinicaltrials.gov NCT02631850 
 
Document Date: May 3, 2017 
 
Revised to include this cover page on August 18, 2021 
 
 

 
 
 
2
Contents 
 
Coverletter ............................................................................................................................................ 4 
Dates of IRB Approvals and Associated Modifications: ..................................................................... 4 
Research Protocol ................................................................................................................................. 5 
Consent Form ..................................................................................................................................... 14 
Adverse event recording form ............................................................................................................ 20 
Withdrawal Form ............................................................................................................................... 22 
Recruitment materials ........................................................................................................................ 23 
Phone Screening ................................................................................................................................. 27 
RCT In-Person Participant Screening Form ....................................................................................... 29 
Treatment materials – CI therapy ....................................................................................................... 33 
Checklist ......................................................................................................................................... 33 
Description of Therapy ................................................................................................................... 37 
Treatment Contract ......................................................................................................................... 38 
Caregiver Contract ......................................................................................................................... 39 
Home Achievement Record of Treatment Contract ....................................................................... 40 
Potential Home Practice Tasks ....................................................................................................... 43 
Home Practice Recording Log ....................................................................................................... 52 
Motor Activity Log Treatment Record .......................................................................................... 53 
Motor Practice Recording Forms ................................................................................................... 54 
Video Recording Log ..................................................................................................................... 57 
Treatment materials – Gaming CI therapy Groups ............................................................................ 58 
Checklist Self-Gaming ................................................................................................................... 58 
Checklist Tele-Gaming .................................................................................................................. 60 
Description of Therapy ................................................................................................................... 63 
Treatment Contract ......................................................................................................................... 64 
Caregiver Contract ......................................................................................................................... 65 
Home Achievement Record of Treatment Contract ....................................................................... 66 
In-clinic Treatment Schedule ......................................................................................................... 69 
In-home game play schedule .......................................................................................................... 70 
Home Practice Recording Log is the same form as for the CI therapy group. .............................. 71 
Game Gestures Key ...................................................................................................................... 72 
Video Recording Log Self-Gaming: .............................................................................................. 74 

 
 
 
3
Video Recording Log Tele-Gaming: .............................................................................................. 75 
MAL in Follow-up Recording Form for Tele-Gaming Group: ...................................................... 76 
Limb Activation Instructions (Pebble Watch): ........................................................................... 77 
Pebble Watch Log: ......................................................................................................................... 78 
Treatment Materials – Usual Care ..................................................................................................... 79 
Traditional Rehabilitation Protocol ................................................................................................ 79 
Traditional Therapy Checklist (Group 4) ....................................................................................... 83 
Video Recording Log ..................................................................................................................... 84 
Usual Care Treatment Log ............................................................................................................. 85 
Assessment Measures ......................................................................................................................... 86 
Treatment Received Form .............................................................................................................. 92 
Demographic Information .............................................................................................................. 97 
Therapist Observations to be collected on LAST day of treatment: .............................................. 98 
 
 
 
 

 
 
 
4
Coverletter 
 
The IRB-approved protocol was written for review by a lay audience. As such, it does not contain as much 
detail about the statistical analysis plan and other more technical details of the trial. The detailed study 
protocol, including statistical analysis plan, was published in BMC Neurology: 
 
Gauthier, L. V., Kane, C., Borstad, A., Strahl, N., Uswatte, G., Taub, E., ... & Mark, V. (2017). Video 
Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative 
effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of 
chronic upper extremity hemiparesis. BMC neurology, 17(1), 1-18. 
 
This trial reflects one aim (Aim 4) within a larger program of research covered in the IRB application that 
began with development of the gaming system (Aims 1-2) and initial pilot testing of the gaming self-
management approach (Aim 3). Only Aim 4 of the IRB application relates to the multi-site randomized 
controlled trial. Only the sections of the IRB pertaining to the randomized controlled trial are included here 
to avoid confusion. Study-related treatment materials that were open-sourced to an internet repository 
referenced within the published protocol are also included within this document. 
 
The trial is registered at Clinicaltrials.gov NCT02631850. 
 
Dates of IRB Approvals and Associated Modifications: 
 
11/23/15 – IRB Amendment Approved for Aim 4 of the Study (the Multi-site Randomized Controlled trial 
presented in this original journal article). 
 
9/20/16 – New recruitment flyers were added based on stakeholder revisions to the text on the original 
recruitment materials and design edits by The Ohio State University’s (OSU) Center for Clinical and 
Translational Sciences. 
 
3/9/17 – Non-significant risk device determination was added for the Recovery Rapids gaming system and 
the smart-watch app to provide feedback on amount of daily arm use.  
 
5/3/17 – A qualitative survey on experience with CI therapy, especially the behavioral techniques, was added 
to the post-treatment testing session if the participant consented to an additional interview with the research 
assistant.  This measure was only administered to a small subset of participants at OSU. 
 
 
 
 

 
 
 
5
Research Protocol 
 
Title A low-cost virtual reality gaming platform for neurorehabilitation of hemiparesis 
 
I. 
Objectives  
A relatively recent rehabilitation strategy, constraint-induced movement therapy (CI therapy), produces substantial 
recovery of arm function. Although viewed as the “gold standard” intervention for arm hemiparesis by many 
practitioners, CI therapy is unavailable to most patients due to its cost, travel/scheduling demands, and dearth of 
trained providers. For example, CI therapy is typically not covered by insurance and the 30+ hours of assessment and 
physical training usually cost patients upwards of $6,000. Most patients are required to travel long distances, often 
out of state, multiple times a week to seek this care. Many of these patients have only intermittent access to 
transportation and/or limited financial means to travel. Thus, patient dissatisfaction with not receiving adequate 
rehabilitation is high and there is a fundamental need for low-cost, accessible interventions with the potential to 
improve arm function. The objective of this project is to test, in collaboration with the patients it is designed to serve, 
a home-based, computer-gaming version of CI therapy that will provide high-quality rehabilitation to patients who 
are typically not afforded access to effective therapies. 
 
Aim 4: A larger randomized controlled trial will be conducted, comparing the effectiveness of a 3D video game 
delivery model of CI therapy versus traditional clinic-based CI therapy and standard care. 
 
Our team’s long-term goal is to use newly available technological innovations to increase access to motor 
rehabilitation while reducing cost of care. In keeping with our overall program of research, the proposed 
work aims to establish the comparative effectiveness of a three-dimensional (3D) video game delivery model 
of CI therapy versus traditional clinic-based CI therapy and standard care. Data from this trial will enable 
individuals with hemiparesis to evaluate whether a home-based video game therapy has the potential to meet 
their rehabilitation goals compared to clinic-based CI therapy and traditional rehabilitation approaches. We 
propose a multisite randomized controlled trial with two subaims: 
Aim 4a: To determine the comparative effectiveness of a therapist-as-consultant video-game delivery model 
of CI therapy. The Motor Activity Log (a reliable and valid measure of arm use for daily activities) and the 
Wolf Motor Function Test (measures time required to perform functional movements) will serve as primary 
motor outcome measures. 
Aim 4b: To examine individual factors that may differentially influence response to one treatment versus 
another. Initial motor ability, cognition, somatosensation, intensity of both in-clinic and home-based motor 
practice, treatment compliance, age, and chronicity will be examined as potential moderators of motor 
outcome. 
II. Background and Rationale 
 
CI therapy is a highly efficacious motor rehabilitation therapy for stroke or hemiparesis of other etiologies.  
It has been shown to substantially increase the amount of use of an affected upper extremity 5-7 and to promote 
structural and functional brain plasticity. 8-12 CI therapy is distinctive from traditional rehabilitation in several 
ways. 1) It involves a highly compressed and intensive training schedule (training of the more impaired arm on 
functional tasks for 3 hours daily for 10 consecutive weekdays).  2) CI therapy incorporates restraint of the less-
impaired (i.e., “good”) hand for a target 90% of waking hours.  Restraint is delivered via a padded mitt that 
discourages the patient to engage in compensatory behavior with the less affected arm 13,14 and teaches the 
patient to use the more-affected (i.e., “bad”) arm for daily activities. 3) CI therapy utilizes a number of behavioral 
techniques termed the “transfer package.” The transfer package was designed to facilitate transfer of therapeutic 

 
 
 
6
gains to real world activities, thereby enabling the patient to overcome the conditioned suppression of movement 
(e.g., learned nonuse) characteristic of chronic hemiparesis.13,14 Transfer package techniques include daily 
monitoring of life situation use of the more affected arm via daily administration of the Motor Activity Log (a 
structured interview that monitors use of the more-impaired arm for 28 daily activities), providing feedback on 
patient progress, and problem-solving with the therapist to overcome perceived barriers to using the extremity.  
 
The transfer package is perhaps the most revolutionary element of CI therapy in that it leverages 
psychological theory to induce behavioral change. Patient gains in real-world arm use are reduced by 
approximately 67% when it is omitted from the CI therapy protocol.12 Furthermore, patients fail to 
demonstrate the brain reorganization that is typical of CI therapy in the absence of the transfer package.12 
Behavior-monitoring and problem-solving elements (strongly emphasized by the transfer package) are 
present in most empirically-validated psychological interventions that target behavior change and their 
importance to the field of physical rehabilitation is becoming increasingly apparent. Traditional approaches 
to motor rehabilitation that heavily emphasize strength, speed, or “normalcy” of movement (i.e., motor 
training only), and do not incorporate elements of the transfer package, often yield motor gains that do not 
translate into improved function for the patient (i.e., the patient still operates unimanually at home). Through 
use of the transfer package, CI therapy patients regain their ability to use both arms for daily tasks, enabling 
them to retain motor gains over time.  
Despite its effectiveness, CI therapy is available to less than 1% of the estimated 1.2 million chronic 
stroke survivors who could benefit from it. Common barriers to access include dearth of trained providers, 
cost, insurance caps, and travel/scheduling demands. Although in its infancy, telemedicine is an emerging 
field with substantial promise to produce exceptional interventions at low cost that can be widely distributed. 
Most studies to date have found that virtual reality interventions are at least as effective as their low-
technology counterparts.1-4  To deliver CI therapy to underserved individuals, a novel patient-centered 
approach to rehabilitation was developed that utilizes newly developed, inexpensive, and commercially 
available gaming technology (Microsoft Kinect). Initial evidence from a pilot trial of this system suggests 
that improvements in motor speed, an outcome of prime importance to stroke survivors, are approximately 
equivalent to those reported in the traditional CI therapy literature. Qualitative data reveal that the technology 
is accepted irrespective of age, technological expertise, ethnicity, or cultural background. A randomized 
clinical trial is now required to provide reliable (level 1) evidence of the effectiveness of this novel model of 
CI therapy delivery. 
III. Procedures  
 
Aim 4. To compare the effectiveness of a 3D video game delivery model of CI therapy versus traditional clinic-
based CI therapy and standard care in a randomized controlled trial. 
 
Administration 
 
OSU will serve as the lead site for a multi-site trial. Communication between sites will occur through quarterly 
phone calls (and more frequently if needed) between OSU PI and the PI of the sites. In-person site visits will also 
occur at the beginning of the project and again after sites have obtained ~25% enrollment. Video-based site visits 
may replace in-person site visits in some instances as appropriate. Site trainings will occur at each site and will 
include procedures necessary for maintaining data security and participant privacy (e.g., procedures for 
uploading study testing forms to secure REDCap database at OSU).  
 
The central database for the project will be maintained at OSU (REDCap). All records for the study will be 
scanned in by each site and uploaded to REDCap. Adherence to study treatment and testing protocols will be 
checked by a blind rater at OSU whose job is to randomly review video-taped treatment and testing sessions. 
Significant deviations from protocol will be addressed by retraining personnel or termination (if the problems 

 
 
 
7
persist). Video data (e.g., see above) will be transferred to OSU from the other sites via USPS on encrypted 
storage drives.  
 
Unanticipated problems (from all sites) will be reported to the OSU PI, OSU’s central IRB, as well as to the 
PIs of individual sites.  To avoid a potentially large volume of reports of external adverse events, the HHS Office 
of Human Research Protections (OHRP) has released guidance urging that individual adverse events should only 
be reported to investigators at all institutions when a determination has been made that the events meet the 
criteria for an unanticipated problem. OHRP recommends that any distributed reports include: (1) a clear 
explanation of why the adverse event or series of adverse events has been determined to be an unanticipated 
problem; and (2) a description of any proposed protocol changes or other corrective actions to be taken by the 
investigators in response to the unanticipated problem. Adverse event reporting for the proposed research will 
follow this model.  
 
An initial analysis of data will be conducted at OSU after 50% total recruitment.  These interim findings will 
be shared with other site PIs by the OSU PI. Decisions to modify the protocol based on interim findings will be 
made jointly between all the sites to ensure protocol consistency. Interim findings that may influence protocol 
safety and willingness to participate will be reported to the IRBs at each institution by the PIs at each institution.   
 
Research Design 
 
Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional 
clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI 
therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) 
therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 
therapist/client contact hours in the clinic, 6 additional brief teleconference sessions, and 15 hours of 
independent game play in the home), and (4) 5 hours of standard occupational therapy. The clinic-based CI 
therapy arm is the "gold standard" against which gaming therapy is compared (group 1 versus group 2 and 
group 3). The comparison to standard care (group 2 versus group 4) will demonstrate whether game-based 
treatment between therapy sessions enhances motor outcomes. The comparison between groups 2 and group 
3 will determine the extent to which additional therapist monitoring via video conference improves treatment 
response of a home-based intervention. Motor function (Wolf Motor Function Test) and daily use of the 
more affected hand (accelerometry) will be measured prior to treatment, after treatment, and 6 months later.  
Sample & Inclusion/Exclusion Criteria 
Relatively relaxed enrollment criteria will be employed to include a representative sample of patients with 
upper extremity motor impairment. Patients who have experienced a stroke (of any etiology) resulting in 
hemiparesis at least six months prior, have preserved ability to comprehend and participate in basic elements 
of the therapy, who have corrected vision of at least 20/70 (individuals with low vision would have difficulty 
participating in the gaming intervention), who are not currently participating in other experimental upper 
extremity trials, who are not currently engaged in other outpatient rehabilitation for their upper extremity, 
and who have not received Botox within the last 3 months (confound) will be eligible to participate. Eligible 
participants will receive an in-person screening to ensure their ability to safely engage in rehabilitation. 
Patients deemed too frail to undergo intensive rehabilitation or those with serious, uncontrolled medical 
problems will be excluded (e.g., debilitating pain). The recruited sample will represent approximately 50% of 
individuals with hemiparesis. Participants will be stratified by severity of impairment (see table below) and 
separately randomized to reduce potential baseline inequality between groups. 
 
Severity of 
Impairment 
Shoulder 
 
Elbow 
 
Wrist 
 
Fingers 
 
Thumb 
Mild-
moderate 
 
Flexion ≥45° and 
Abduction ≥45° 
Extension ≥20° 
from a 90° flexed 
starting position 
Extension ≥20° 
from fully flexed 
starting position 
Extension of all 
MCP and (PIP or 
DIP) joints ≥10° 
Extension or 
abduction of 
thumb ≥10° 
Moderate 
Flexion ≥45° and 
Extension ≥20° 
Extension ≥10° 
Extension MCP 
Extension or 

 
 
 
8
 
Abduction ≥45° 
from a 90° flexed 
starting position 
 
from fully flexed 
starting position 
 
and (PIP or DIP) 
joints of at least 2 
fingers ≥10° 
abduction of 
thumb ≥10° 
 
 
Measurement/Instrumentation 
 
Primary measures: 
- 
Motor Activity Log 
-  
Wolf Motor Function Test 
 
Secondary measures: 
- 
bilateral activity monitors (accelerometers) 
- 
Patient Health Questionnaire (PHQ-9)  
- 
Touch Test Monofilaments 
-  
Neuro-QOL  
-     9-Hole Peg Test 
-     Brief Kinesthesia Test 
- 
Kinematic Analysis (performed on skeletal Kinect data collected during game play) 
- 
Montreal Cognitive Assessment (MoCA) 
 
Measures will be administered within a week prior to beginning treatment, in the week following treatment, 
and at 6-month follow-up (±1 month). A rehabilitation professional blinded to treatment condition will 
perform the testing. Reliability of the blinded assessors will be monitored by videotaped assessments 
reviewed by independent raters.  
 
Additional quality metrics that could create apparent differences in effectiveness in clinical populations will 
also be measured. After completion of participation, we will survey participants to collect qualitative 
feedback regarding their experiences with the treatment. Participants will be asked about which therapy 
condition (traditional CI therapy, gaming CI therapy, standard therapy) they would have preferred under 
ideal (i.e., cost and transportation are not an issue) and realistic (i.e., their current resources are a 
consideration) conditions. Differential adherence will also be examined by the proportion of therapy sessions 
attended, hours of mitt use objectively quantified by a sensor in the mitt, hours of game play, and self-
reported compliance with home practice.  
 
Outcome measure 
Addresses 
Pre 
Post 
6mo 
Motor Activity Log 
Nonuse for daily activities 
x 
x 
x 
WMFT 
Motor speed/function  
x 
x 
x 
Grip strength of WMFT99 
Weakness 
x 
x 
x 
Kinematics 
Weakness, range of motion, motor control, ataxia, 
poor precision, speed, hypertonicity 
x 
x 
x 
Neuro-QOL 
Quality of Life 
x 
x 
x 
Activity monitoring 
Nonuse for daily activities 
x 
x 
x 
Brief Kinesthesia Test  
Sensory proprioception 
x 
x 
x 
Touch Test Monofilaments  
Tactile loss 
x 
x 
x 
Montreal Cognitive Assessment (MoCA) 
Cognitive screen 
x 
 
 

 
 
 
9
Survey 
 
 
x 
 
 
 
Recruitment  
 
Participants will be primarily recruited through mining the electronic medical records (e.g., through 
Information Warehouse at Ohio State University Wexner Medical Center and the Quality and Patient Safety 
Department at OhioHealth) to generate a list of potentially eligible participants [not deceased individuals 
with an ICD-9 diagnostic code of 438.2 (chronic hemiparesis) or 438.3 (chronic monoplegia of upper limb) 
or ICD-10 equivalent]. After obtaining approval to contact potential participants from their treating 
providers, they will be informed of the study through a mailing. Interested participants will contact the site 
coordinator to be screened for participation. Members of the health system who use a system such as OSU 
MyChart will also be recruited via targeted messaging (to those who may meet recruitment criteria based on 
the diagnostic codes above). A message would appear in their MyChart account, telling them very briefly 
about the study and asking them if they are interested in learning more. If they indicate on MyChart that they 
are interested in being approached about research participation, the PI will receive a message to follow up 
with the potential participant. Participants will also be recruited from community stroke groups, from internet 
forums, via study flyers posted within the community, from the general clientele of the outpatient clinics, 
through internet advertising (e.g., Facebook), through direct mailing (e.g., USPS Direct) and through the use 
of Research Match. Internet advertising, direct mailing, and study flyers posted within the community will be 
used to specifically target rural dwelling participants.  
 
Detailed Study Procedures 
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality 
gaming delivery of CI therapy with (1) traditional clinic-based CI therapy of equal total duration and (2) a 
control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to 
one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), 
(2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 
hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with 
additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 6 brief contacts 
via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard 
occupational therapy. After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a 
modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional 
therapist contact).  This crossover design is ethically responsible and will enable the team to test the 
feasibility and initial efficacy of a completely stand-alone implementation of the game, as well as to 
determine the effect of varying amounts of therapist contact on game-based rehabilitation outcomes (group 2 
vs group 3 vs group 4 crossed over).  
 
Table: Timeline of Participation 
STUDY 
ARM 
 
Pre-tx 
testing, 
week 1 
THERAPY (weeks 2-4) 
 
Post-tx 
testing,  
week 5 
 
6 month 
follow-up 
testing 
THERAPY 
 
CI therapy 
35 face-to-face hours, 15 
spent in active motor 
practice 
 
 
CI therapy 
gaming (2) 
5 face-to-face hours, 15 
hours in-home gaming 
 
 
CI therapy 
gaming (3) 
5 face-to-face hours, 2.6 
teleconsultation hours, 15 
 
 

 
 
 
10
hours in-home gaming 
Standard 
care 
5 face-to-face hours 
15 hours in-
home gaming 
Post-
gaming 
testing 
 
 
Group 1, Traditional CI therapy: We will employ a 35-hour “dose” of CI therapy in the current trial. All 
elements of traditional CI therapy will be provided.  Treatment will consist of 35 therapist/client contact 
hours in the clinic, over the course of 3 weeks. Delivery of the “transfer package” will occur during the other 
5 hours and will include the following elements: (1) establishing a behavioral contract (in which goals for the 
intervention are set, the therapist secures the client’s “buy in,” a plan for increased use of the more affected 
upper extremity in the home setting is drafted, and a schedule of mitt use is established), (2) daily 
administration of the Motor Activity Log (self-assessment of weaker arm use for daily activities), (3) a daily 
diary of new activities attempted at home is reviewed, and (4) problem-solving to overcome barriers to use of 
the more affected upper extremity is conducted. In addition, the client will agree to wear a padded restraint 
mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily 
activities. The restraint mitt is equipped with a sensor to provide the participant with feedback on how long 
he/she has worn the mitt. Finally, the participant will agree to 30 minutes per day of individualized task-
practice outside the clinic (in addition to training in the clinic) focused on functional activities catered 
towards accomplishing the person’s therapeutic goals. 
 
Group 2, Gaming CI therapy. This intervention is designed such that physical/occupational therapists 
manage patients in a consultative role, thus allowing more patients to be served. 5 therapist/client contact 
hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment 
elements that cannot be readily addressed through the game (e.g., transfer package with guided problem-
solving). The first session with the therapist (2 hours) will involve establishing the behavioral contract, 
reviewing the Motor Activity Log (from pre-test) with guided problem-solving, and customizing the game to 
the participant. Thereafter, sessions will focus on review of progress with the home program, modifying 
game customization as needed, and on treatment elements that cannot be readily addressed through the game 
(e.g., guided problem-solving portion of the transfer package with ADL practice as needed, establishing 
home skill assignments collaboratively). Matching the CI therapy delivery schedule, 15 hours of progressive 
massed motor practice will occur through in-home video game play over 3 weeks. Participants will play the 
game during times of their choosing. The proposed delivery system thus allows patients access to 
rehabilitation between episodes of care provided by therapists. This distribution of activities amounts to the 
same amount of active motor practice as CI therapy (15 hours) and 5 hours of “transfer package” activities, 
equivalent to that of traditional CI therapy. In lieu of the mitt, the participant will wear an activity monitor 
biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to 
an additional 30 minutes per day of individualized task-practice.  
Game play is driven by the user’s movements that are captured with the Microsoft Kinect/Xbox One 
camera (cost of less than $500). The Microsoft Kinect is a controller-free motion capture device with built-in 
video cameras and 3D depth sensors to capture and record participant motion. An avatar then replicates the 
participant’s movements in the gaming environment. The “controller-free” environment makes the Kinect 
system user-friendly for patients who are not accustomed to technology and provides monitoring of the 
user’s actual movements. Its intuitive design is thus ideal for rehabilitation applications in which individuals 
may have little comfort with technology or substantial cognitive impairment. It is well suited for 
rehabilitation because it requires no devices or wires to be attached to the person and can capture fairly 
accurate representations of coordinated motor patterns. Components of the system include a computer with 
PC Kinect (or Xbox One integrated gaming console), an armless chair where the patient can safely sit to 
perform the game, and a television display.  

 
 
 
11
The movements required to navigate the game environment were designed to be intuitive (based on 
input from our stakeholders), while also focusing on motor routines known to be helpful for recovery of 
hemiparesis (e.g., extension, supination). Various therapeutic gestures (e.g., how the hand moves relative to 
the shoulder and elbow) drive game play. Therapeutic gestures were coded with a focus on minimizing 
reinforcement of compensatory movement patterns and have been validated on more than 40 individuals with 
hemiparesis.  
The game environment (also developed with input from stakeholders) consists of a quest down a 
river canyon that winds through various terrains (mountains, tropical, dessert, and underground caves). The 
user must paddle a kayak through this terrain, collecting hidden treasure, fishing for food, capturing essential 
supplies that are parachuted down from above, gathering food, and pulling objects from the river. The user 
must remain vigilant; bats and otherworldly creatures can attack in the caves, river rapids can crash the kayak 
into the rocks, and low hanging obstacles need to be avoided or the avatar will develop a headache.  
To promote the extended game-play required for CI therapy and enable customization to the user, the 
game utilizes procedural content generation (mathematical algorithms that generate game content based on 
therapist specifications and continuously change game scenery “on the fly”).  The CI therapy principal of 
shaping (progressively increasing task difficulty as a person improves) is automated through the game. In 
just one example, bats flock around the avatar’s head to encourage the user to raise the paretic hand above 
the shoulder and across the body. To disperse the bats, the player must “swat” the bats out of the way with 
the paretic hand. An introductory level of this gesture may require only that the paretic hand reaches above 
the level of the navel. As a person’s range of motion improves, the game advances the player to reach across 
midline in addition to above shoulder level and, eventually, to higher above the shoulder and further across 
the body. 
As with traditional CI therapy, the game also incorporates some elements of the “transfer package” 
that promote transfer of motor gains to daily activities. One such element is the Motor Activity Log (MAL). 
It is a highly structured self-monitoring interview that asks patients how effectively their more affected arm 
performed activities of daily living over the past 48 hours. Daily administration of the MAL is believed to be 
the most important element of the “transfer package” because it provides self-monitoring of arm use and 
problem-solving regarding how the client can incorporate use of the more affected upper extremity into 
his/her daily routine. To automate this self-assessment, the user matches his/her performance to a video of a 
stroke participant performing each task. If participants answers that he/she did not perform an activity, a 
problem-solving module appears in which the user must select from various strategies that may aid him/her 
in performing the task (strategies were provided by therapist stakeholders).   
 
Group 3, Gaming CI therapy with additional contact via video conference. This group will receive 
treatment that is identical to Group 2, but will receive an additional 6 brief video conference consultations 
throughout the treatment period so that this group receives the same number of therapist encounters as the CI 
therapy group. 
 
Group 4, Traditional occupational/physical therapy focusing on the upper extremity. Five 
therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as 
gaming CI therapy). The treatment protocol was developed collaboratively by therapists on our Advisory 
Board given the question: “What protocol would you utilize if you were only given 5 contact hours to treat a 
client [with mild/ moderate hemiparesis]?” Although responses differed somewhat regarding the relative 
amounts of time devoted to the following activities, an average protocol was constructed consisting of the 
following: 1-hour progressive resistance exercise to establish and progress an upper extremity home exercise 
program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal 
encouragement to use the more affected upper extremity to the largest extent possible. Home practice 
consists of stretching exercises, designed to increase range of motion, prescribed twice daily. After 
completing their participation in the standard OT condition (6 months), participants will be crossed over to a 
CI therapy gaming only condition. This condition will be identical to that described above, excluding 
therapist contact throughout the intervention. Following an initial consultation with a therapist, participants 

 
 
 
12
will receive a DVD explaining the intervention and guiding them through self-management. The rationale for 
crossing over participants in the standard occupational therapy condition is two-fold: 1) this will allow 
testing the efficacy of a stand-alone implementation of the game (the only feasible treatment option for 
participants who are unable to access a clinic), and 2) it is ethically responsible given our hypothesis that the 
standard OT group will show inferior outcomes compared to the groups receiving CI therapy or gamified CI 
therapy. 
 
Data handling- The OSU CCTS Research Informatics Services Core will be used as a central location for 
data processing and management. Vanderbilt University, with collaboration from a consortium of 
institutional partners (including OSU) and the NIH National Center for Research Resources, has developed a 
software toolset and workflow methodology for electronic collection and management of research and 
clinical trial data. REDCap (Research Electronic Data Capture) data collection projects rely on a thorough 
study-specific data dictionary defined in an iterative self-documenting process by all members of the 
research team with planning assistance from the CCTS Research Informatics Services Core. As part of the 
data dictionary development process, individual fields can be denoted as “identifiers”. When exporting a de-
identified dataset, these variables are omitted. Additionally, the data export tool also allows for the shifted of 
dates for a limited data set export. REDCap provides a secure, web-based application that is flexible enough 
to be used for a variety of types of research, provides an intuitive interface for users to enter data and has real 
time validation rules (with automated data type and range checks) at the time of entry. It offers easy data 
manipulation with audit trails and ad hoc reporting functionality for reporting, monitoring and querying 
patient records, and an automated export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-
Plus). REDCap is 21 CRF Part 11 capable. Currently, REDCap installations support electronic signatures by 
positively identifying the user through a unique username and password combination. The provisioning of 
accounts and user access to specific database(s) is integrated with the OSU Medical Center LDAP 
authentication service for studies containing protected health information (PHI), and the provisioning of 
access and specific user rights for all studies are managed by CCTS staff.  
 
Handling missing data - We will prevent missing data through the use of checklists. These checklists will 
ensure that all measures are collected at each assessment session in a consistent order according to study 
protocol. Checklists will also minimize data loss due to technical difficulties (e.g., improper initialization of 
the bilateral activity monitors, dead batteries, etc.). Automated reminder calls will be sent to participants to 
reduce missed appointments and to remind participants to wear the activity monitors. Missed appointments 
will be rescheduled immediately. Testing data will be entered into a secure (and backed-up) REDCap 
database within 48 hours of data collection. Reasons for drop-out (and whether drop-out was therapist or 
participant-initiated) will be documented in detail. Loss to follow-up will be minimized by collecting 
multiple types of contact information and an alternate contact for the participant should he/she be 
unreachable. 
 
Data Analysis- Missing data from participants who are unable to complete the protocol (e.g., due to random 
factors unrelated to the study protocol) will be removed from analysis via list-wise deletion. An intent-to-
treat analysis will be carried out such that data from participants who voluntarily withdraw from treatment or 
are unable to tolerate the treatment protocol will be included; the mixed effects model planned for analysis is 
purely likelihood-based and can make use of all of the data available with no necessary modifications for 
differing numbers of subjects at each time point. Therapy-induced changes in motor ability (primary outcome 
measures of accelerometry and WMFT) will be analyzed via mixed effects linear models.  Initially, separate 
models will be constructed for the two primary outcome measures.  Each of these models will include 
treatment and time (as well as their interaction) as fixed effects and subject as a random effect.  In these 
models, the interaction of treatment and time is the primary effect of interest, since it quantifies the 
difference in change over time among the four treatment groups. Statistical testing will be used to determine 
whether individuals lost to follow-up differ from those who completed the study.  Demographic measures 

 
 
 
13
and initial scores on outcome variables will be compared between groups using t-tests, chi-squared tests, or 
their non-parametric analogues. Significant differences will be considered in interpretation of the results. 
Results will be reported according to the CONSORT guidelines. 
 
REFERENCES 
(1) Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane 
Database Syst Rev. 2011;9:CD008349. 
(2) Piron L, Turolla A, Agostini M, Zucconi C, Cortese F, Zampolini M, Zannini M, Dam M, Ventura L, Battauz 
M, Tonin P. Exercises for paretic upper limb after stroke: a combined virtual-reality and telemedicine approach. J 
Rehabil Med. 2009;41:1016-1102. 
(3) Henderson A, Korner-Bitensky N, Levin M. Virtual reality in stroke rehabilitation: a systematic review of its 
effectiveness for upper limb motor recovery. Top Stroke Rehabil. 2007;14:52-61. 
(4) Holden MK. Virtual environments for motor rehabilitation: review. Cyberpsychol Behav. 2005;8:187-211; 
discussion 212-9. 
(5) Taub E, Miller NE, Novack TA, Cook EW,3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. 
Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993;74:347-54. 
(6) Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, Giuliani C, Light KE, Nichols-Larsen D, 
EXCITE Investigators. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 
months after stroke: the EXCITE randomized clinical trial. JAMA. 2006;296:2095-2104. 
(7) Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-
induced movement therapy for upper extremity after stroke. Stroke. 2006;37:1045-9. 
(8) Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical 
reorganization after stroke in humans. 2000;31:1210-1216. 
(9) Kopp B, Kunkel A, Muhlnickel W, Villringer K, Taub E, Flor H. Plasticity in the motor system related to 
therapy-induced improvement of movement after stroke. Neuroreport. 1999;10:807-810. 
(10) Schaechter JD, Kraft E, Hilliard TS, Dijkhuizen RM, Benner T, Finklestein SP, Rosen BR, Cramer SC. 
Motor recovery and cortical reorganization after constraint-induced movement therapy in stroke patients: a 
preliminary study. 2002;16:326-338. 
(11) Wittenberg GF, Chen R, Ishii K, Bushara KO, Taub E, Gerber LH, Hallett M, Cohen LG. Constraint-
Induced therapy in stroke: magnetic-stimulation motor maps and cerebral activation. 2003;17:48-57. 
(12) Gauthier LV, Taub E, Perkins C, Ortmann M, Mark VW, Uswatte G. Remodeling the brain: plastic 
structural brain changes produced by different motor therapies after stroke. Stroke. 2008;39:1520-5. 
(13) Morris DM, Shaw SE, Mark VW, Uswatte G, Barman J, Taub E. The influence of neuropsychological 
characteristics on the use of CI therapy with persons with traumatic brain injury. 2006;21:131-137. 
(14) Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for 
rehabilitation. Eura Medicophys. 2006;42:241-56. 
(15) Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of 
the hemiparetic arm after stroke. Neurology. 2006;67:1189-94. 
(16) Turnbull AP, Friesen BJ, Ramirez C. Participatory Action Research as a Model for Conducting Family 
Research. JASH. 1998;23: 178-188. 
(17) McTaggart R. Principles for Participatory Action Research Adult Education Quarterly. 1991;41:168-187. 
(18) Whyte W editor. Participatory action research. Thousand Oaks, CA, US: Sage Publications, Inc.; 1991. 
(19) Venkatesh V, Morris MG, Davis FD, and Davis GB. User Acceptance of Information Technology: Toward a 
Unified View. MIS Quarterly. 2003;27:425-478. 

CONSENT 
Biomedical/Cancer 
 
 
 
IRB Protocol Number: 2012H0151 
 
IRB Approval date: 5/3/17 
 
 
 
 
 
 
14
Consent Form 
 
The Ohio State University Consent to Participate in Research 
 
Study Title:  
A low-cost virtual reality gaming platform for 
neurorehabilitation of hemiparesis 
Principal Investigator: 
Lynne V. Gauthier, PhD 
Sponsor:  
Patient-Centered Outcomes Research Institute; Departments of 
Physical Medicine & Rehabilitation and Computer Science, 
OSU 
Aim 4 Consent form: 
 
• This is a consent form for research participation.  It contains important information about 
this study and what to expect if you decide to participate.  Please consider the information 
carefully. Feel free to discuss the study with your friends and family and to ask questions 
before making your decision whether or not to participate. 
• Your participation is voluntary.  You may refuse to participate in this study.  If you decide 
to take part in the study, you may leave the study at any time.  No matter what decision you 
make, there will be no penalty to you and you will not lose any of your usual benefits.  Your 
decision will not affect your future relationship with The Ohio State University, Ohio 
Health, Providence Medford Medical Center, or the University of Alabama at Birmingham.  
If you are a student or employee at one of these institutions, your decision will not affect 
your grades or employment status. 
• You may or may not benefit as a result of participating in this study.  Also, as explained 
below, your participation may result in unintended or harmful effects for you that may be 
minor or may be serious depending on the nature of the research. 
• You will be provided with any new information that develops during the study that 
may affect your decision whether or not to continue to participate.  If you decide to 
participate, you will be asked to sign this form and will receive a copy of the form.  You are 
being asked to consider participating in this study for the reasons explained below.   
 
1.   Why is this study being done? 
We are doing this study to compare how well four different therapies help people recover motor 
function after stroke.  
 
2.   How many people will take part in this study? 
Up to 400 people who have had a stroke will participate. 
 
 
3.   What will happen if I take part in this study? 
 

CONSENT 
Biomedical/Cancer 
 
 
 
IRB Protocol Number: 2012H0151 
 
IRB Approval date: 5/3/17 
 
 
 
 
 
 
15
You will pick a sealed note card from an envelope. When you open the note card, it will tell you 
which study treatment that you will receive. The four possible treatments are:  
 
Group 1: Traditional Constraint-Induced Movement Therapy (CIT) involves 35 hours of 
therapy in the clinic within 3 weeks. During these 3 weeks, you will wear a padded mitt on your 
stronger hand.  The purpose of the mitt is to remind you to do daily activities with your weaker 
hand. You will also complete a number of tasks to help you to carry-over the gains that you 
make in the clinic to daily life. These include practicing motor activities at home (e.g., folding 
laundry) for 30 minutes per day, signing a contract agreeing to wear the padded mitt and to 
practice using your weaker arm, answering a daily questionnaire about your arm use, and 
problem-solving with a therapist to overcome challenges to using your weaker arm. 
 
OR 
 
Group 2: The rehabilitation game with 5 hours therapist contact involves 15 hours of arm and 
hand therapy over 3 weeks in your own home by playing a video game. The game is easy to 
learn and involves moving your weaker arm and hand to control your character on the screen. 
No previous experience with video games is needed to learn the game. The game will also ask 
you how often you use your arm for different daily activities and will help you to problem-solve 
ways to use your weaker arm more often. During the three-week period of therapy, you will 
wear a smart watch for the majority of waking hours. The purpose of the watch is to remind you 
to practice daily activities with the weaker hand by alerting you when your arm is inactive. You 
will also complete a number of tasks to help you to carry-over the gains that you make in the 
clinic to daily life. These include practicing motor activities at home (e.g., folding laundry) for 
30 minutes per day, signing a contract agreeing to practice everyday activities with your weaker 
arm, answering a daily questionnaire about your arm use, and problem-solving with your 
therapist to overcome challenges to using your weaker arm. You will meet face-to-face with 
your therapist 4 times, for a total of 5 hours. The purpose of these sessions will be to personalize 
the game to you and to teach you to use your weaker arm to perform daily tasks more 
effectively. On the last day of treatment you will fill out a brief survey regarding your 
experience and future uses of the gaming system. 
 
OR 
 
Group 3: The rehabilitation game with 5 hours face-to-face therapist contact and additional 
therapist contact via videoconference. This treatment is the same as Group 2, but an additional 
2.6 hours of video contact with your therapist is added. The video contact will occur in your 
home (similar to a Skype call). During these video sessions, your therapist will ask you about 
your progress and will problem-solve through any challenges to using your weaker arm for daily 
activities.   
 
OR 
 
Group 4: Occupational therapy. You will meet with a therapist 4 times in the clinic for a total 
of 5 hours over a three-week period. The therapist will do stretching and movement exercises 

CONSENT 
Biomedical/Cancer 
 
 
 
IRB Protocol Number: 2012H0151 
 
IRB Approval date: 5/3/17 
 
 
 
 
 
 
16
with you. You will also do exercises at home every day. After 6-month follow-up, you will 
receive the in-home game to play.  
 
Regardless of which treatment group you are assigned to, you will receive a lot of therapy 
(about 35 hours). You will receive motor and cognitive testing before you begin treatment, after 
treatment, and after 6-months. Each testing session will take no longer than 3 hours. Testing and 
therapy sessions will be video-taped. Testing sessions will involve moving your stronger and 
weaker arms, detecting touch sensation, and answering questions about your mood, thinking, 
and quality of life. In some cases, some measures may be administered over the phone. During 
research visits to The Ohio State University Medical Center, you may be asked to perform some 
tests of movement coordination. Finally, you will be asked to wear activity tracker bands during 
the study period and for two days surrounding each testing period to estimate how frequently 
you move your arms.  
 
We will ask for your permission to contact the people with whom you live (or others who know 
you well). This is routine clinical care that will give us a second opinion as to how you are 
doing at home and how to personalize the intervention for you. It will also allow us to teach the 
therapy to people who know you well. We will not obtain information from family, friends, or 
caregivers without your permission and will not share your personal health information with 
them. 
 
4.   How long will I be in the study? 
If you are in Group 1, you will spend 44 hours of your time over the first 4 weeks of the study.  If 
you are in group 2, you will spend 24 hours of your time over the first 4 weeks of the study.  If 
you are in group 3, you will spend 26 hours of your time over the first 4 weeks of the study.  If 
you are in Group 4, you will spend 14 hours of your time over the first 4 weeks of the study.  6 
months later, you will participate in a follow-up evaluation to determine how well you have 
maintained your motor gains over time.  Group 4 will then receive gaming therapy (immediately 
following 6-month testing) for 15 hours and will receive a post-gaming testing session within one 
week after completion of the game.  
 
5.   Can I stop being in the study? 
You may leave the study at any time.  If you decide to stop participating in the study, there will 
be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.  
Your decision will not affect your future relationship with The Ohio State University.  
 
6.   What risks, side effects or discomforts can I expect from being in the study? 
Risks of participating in this study are similar to the risks of low impact exercise and other motor 
therapies after stroke. The assessment measures and treatments used are safe & noninvasive. 
Potential risks include potential fatigue and frustration during therapy and/or testing.  It is 
possible, though unlikely, that you will experience mild stress, anxiety, or emotional distress 
during testing or rehabilitation.   
 
 
 

CONSENT 
Biomedical/Cancer 
 
 
 
IRB Protocol Number: 2012H0151 
 
IRB Approval date: 5/3/17 
 
 
 
 
 
 
17
7.   What benefits can I expect from being in the study? 
You might not receive any benefit from participating in this study. You will receive treatment for 
your arm weakness at no cost to you or to your insurance company. We expect that the therapies 
being tested in this study will benefit you, but there is the chance that the form of therapy that 
you are assigned to may not be effective.   
 
8.   What other choices do I have if I do not take part in the study? 
You may choose not to participate without penalty or loss of benefits. You have the option of 
receiving therapy as part of your clinical care, rather than through this research study. There are 
currently at least two available clinical avenues for receiving CIT: 1) you could receive a more 
spread out form of the therapy at Morehouse Neurorehabilitation clinic at OSU; 2) you could 
receive the 2 week therapy program (the same training program provided in this study) at the 
Taub Neurorehabilitation clinic at the University of Alabama at Birmingham.   
 
9.   Will my study-related information be kept confidential? 
Efforts will be made to keep your study-related information confidential.  However, there may be 
times where this information must be released.  For example, if required by state law.   
 
Also, the following groups may review your records: 
• 
Office for Human Research Protections or other federal, state, or international regulatory 
agencies; 
• 
U.S. Food and Drug Administration; 
• 
The Institutional Review Board or Office of Responsible Research Practices; 
• 
The sponsor supporting the study, their agents or study monitors 
 
Given that this study involves a rehabilitation intervention that is related to your medical care, 
your study-related information may be placed in your permanent hospital, clinic, or physician’s 
office records. Authorized staff involved in your medical care may be aware that you are 
participating in a research study and have access to your information.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. law.  This website will not include information that can identify you.  At most, the 
website will include a summary of the results.  You can search the website at any time.  
 
You will also be asked to sign a separate Health Insurance Portability and Accountability Act 
(HIPAA) research authorization form because the study involves the use of some protected 
health information. 
 
10. What are the costs of taking part in this study? 
If you need to park at the Medical Center for an appointment, you will be responsible for the 
cost of parking. 
 
11. Will I be paid for taking part in this study? 
A travel reimbursement of $50 per testing session will be given to each participant. Each 
participant who completes the in-home portions of the study protocol will receive a T-shirt and 

CONSENT 
Biomedical/Cancer 
 
 
 
IRB Protocol Number: 2012H0151 
 
IRB Approval date: 5/3/17 
 
 
 
 
 
 
18
will also be entered into a drawing for a $25 gift card. By law, payments to participants are 
considered taxable income.  
 
12. What happens if I am injured because I took part in this study? 
If you suffer an injury from participating in this study, you should notify the research team 
immediately, and you should obtain medical treatment if needed.  The cost for this treatment 
will be billed to you or your medical or hospital insurance. The Ohio State University has no 
funds set aside for the payment of health care expenses for this study.  
 
13. What are my rights if I take part in this study? 
If you choose to participate in the study, you may discontinue participation at any time without 
penalty or loss of benefits.  By signing this form, you do not give up any personal legal rights 
you may have as a participant in this study. 
 
You will be provided with any new information that develops during the course of the research 
that may affect your decision whether or not to continue participation in the study. 
 
You may refuse to participate in this study without penalty or loss of benefits to which you are 
otherwise entitled. 
 
An Institutional Review Board responsible for human subjects research at The Ohio State 
University reviewed this research project and found it to be acceptable, according to applicable 
state and federal regulations and University policies designed to protect the rights and welfare of 
participants in research. 
 
14. Who can answer my questions about the study? 
For questions, concerns, or complaints about the study you may contact:  
Dr. Lynne Gauthier 614-293-3480. 
 
For questions about your rights as a participant in this study or to discuss other study-related 
concerns or complaints with someone who is not part of the research team, you may contact Ms. 
Sandra Meadows in the Office of Responsible Research Practices at 1-800-678-6251. 
 
If you are injured as a result of participating in this study or for questions about a study-related 
injury, you may contact Dr. Lynne Gauthier 614-293-3480. 
 
15. Disclosures: 
The Recovery Rapids game and HandsOn app utilized in this research are in the process of being 
commercialized by Games that Move You, PBC to enable public access. The following 
investigators are cofounders of this company: Drs. Lynne Gauthier, Roger Crawfis, Alexandra 
Borstad, Linda Lowes, and Ryan McPherson.  A conflicts management plan has been put in 
place to ensure the integrity and transparency of the research.   
 
The Ohio State University owns the software used in this research, and they will receive royalties 
if it is sold.  

CONSENT 
Biomedical/Cancer 
 
 
 
IRB Protocol Number: 2012H0151 
 
IRB Approval date: 5/3/17 
 
 
 
 
 
 
19
Signing the consent form 
 
I have read (or someone has read to me) this form and I am aware that I am being asked to 
participate in a research study.  I have had the opportunity to ask questions and have had them 
answered to my satisfaction.  I voluntarily agree to participate in this study.  
 
I am not giving up any legal rights by signing this form.  I will be given a copy of this form. 
 
 
 
 
 
Printed name of subject 
 
Signature of subject 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
 
 
 
 
Printed name of person authorized to consent for subject 
(when applicable) 
 
Signature of person authorized to consent for subject  
(when applicable) 
 
 
 
 
 
AM/PM 
Relationship to the subject 
 
Date and time 
 
 
 
 
Investigator/Research Staff 
 
I have explained the research to the participant or his/her representative before requesting the 
signature(s) above.  There are no blanks in this document.  A copy of this form has been given to 
the participant or his/her representative. 
 
 
 
 
 
Printed name of person obtaining consent 
 
Signature of person obtaining consent 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
Witness(es) - May be left blank if not required by the IRB 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 
 
Printed name of witness 
 
Signature of witness 
 
 
 
 
 
 
AM/PM 
 
 
Date and time 
 
 
 
 

 
 
20
Adverse event recording form 
 
Return this COMPLETED FORM to your site PI as soon as possible. Site PI will notify Dr. Gauthier of the 
event. 
 
Study Title: Comparative Effectiveness of a Low-cost Virtual Reality Platform for Rehabilitation of 
Hemiparesis 
Participant name: ______________________  
Participant Number: ____________________ 
Age: ________ DOB: ___________________ 
Sex (circle one): Male 
Female     Other 
 
EVENT REPORT 
 
Check Type of Event: 
 
 
 
 
 
 
 Study-related injury  
 Participant complaint (e.g., muscle soreness) 
 Policy/Procedural Violation(s)  (e.g., breaking confidentiality, breaking randomization, incorrectly 
administering the intervention) 
 Medical complication (e.g., surgery, injury outside study participation, illness) 
 Psychological distress 
 Other  
 
Please describe nature of adverse event: 
______________________________________________________________________________________
______________________________________________________________________________________
________________________________________________________________________________ 
 
Was this event expected or unexpected? (circle one)    EXPECTED 
UNEXPECTED 
 
 
Expected event: An event will be considered expected if the nature, severity, or frequency of the 
event is consistent with the risk information previously described for the intervention (i.e. muscle 
soreness, fatigue, frustration). 
 
Unexpected event: An event will be considered unexpected if the nature, severity, or frequency of 
the event is inconsistent with the risk information previously described for the intervention (e.g., a 
fall).  
 
INVOLVEMENT OF RESEARCH PERSONNEL/RESPONSE 
 
Did the event occur during study treatment or testing? (circle one)    
YES 
 
NO   
*If yes, please continue to question #1. If no, skip to #3. 
 
1. Describe event/complaint (Who, What, When, Where, How, Why; Include sequence of events, 
personnel involved, nature of injury): 
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________ 
 
2. Were there any witnesses to the event? If yes, please list names and contact information for each: 
 
Witness Name: ________________________________ Phone Number: ___________________ 
 
Witness Name: ________________________________ Phone Number: ___________________ 

 
 
21
 
3. How was the event managed at time of occurrence (if occurred in course of treatment, testing, 
follow-up at site)? 
________________________________________________________________________________
________________________________________________________________________________
_______________________________________________________________________ 
 
MEDICAL FOLLOW UP 
 
Was Medical Attention Sought (circle one): YES  NO 
 
Date of appointment: __________ 
 
Treatment received (circle one): YES 
 NO 
First Treatment Date:  __________ 
Treating Physician:  ________________________________ Phone Number:  _______________ 
 
Does participant plan to seek medical attention? (circle one): YES 
 NO 
 
REPORTING 
 
Incident/Complaint Documented By: _____________________ Date: __________ Time: ______ am/pm 
 
Site PI Notified (circle one):   
  YES  NO 
Date:  ___________  Time:  _______________ am/pm 
 
Dr. Gauthier Notified (circle one):  YES  NO 
Date:  ___________  Time:  _______________ am/pm 
 
Corrective Action Taken/Follow-Up (What has been done or will be done to prevent recurrence): 
______________________________________________________________________________________
______________________________________________________________________________________
________________________________________________________________________________ 
 
Will participant continue in study? (circle one): YES 
 NO 
 
If no, state reason for withdrawal: __________________________________________________ 
   
Signature and Title of Person Preparing Report:  ______________________________ Date: _________ 
 
Signature of Person making Complaint:  _____________________________________ Date: ________ 
 
Does this event require reporting to IRB?  
 
• 
Is the event unexpected, serious, and related to the research (circle one)?:  YES   NO 
 
o 
Unanticipated problems that are serious adverse events (SAE’s) should be reported to the 
IRB within 48 hours of the investigator becoming aware of the event. 
 
o 
Any other unanticipated problem should be reported to the IRB within 2 weeks of the 
investigator becoming aware of the problem if the problem is study-related.  
 
o 
All other events will be reported to the IRB during annual review. 
 
*Signing below indicates PI acknowledges responsibility for contacting appropriate IRB to report above 
documented event/incident/complaint. 
 
PI Signature:  _________________________________________________________ Date: __________ 

 
 
22
Withdrawal Form 
 
Participant ID: ___________________ 
Date of Withdrawal: ______________  
Reason for withdrawal (circle one):       by self          by staff   
Description of reason for withdrawal:  
 
 
 

 
 
23
Recruitment materials 
 

 
 
24
s 

 
 
25
 

 
 
26
 
 
 
 
Date 
 
Dear (name), 
 
Your [insert care provider service or name here] would like you to be aware of important 
research studies being conducted at The Wexner Medical Center.  Researchers are 
looking for participants who have experienced a stroke and continue to have trouble using 
their weaker side. The enclosed brochure[s] describe[s] studies that are now enrolling 
participants.  
 
If you are interested in participating or learning more about a study, please do one of the 
two following actions:  
1. Contact us at XXXXXX for more information. 
2. E-mail us at XXXXXX@osumc.edu 
 
We would like the opportunity to help you learn more about Stroke rehabilitation research 
at The Wexner Medical Center.  
 
As with all research conducted at the Wexner Medical Center, your participation is 
voluntary. There will be no consequences to you if you choose not to participate; your 
medical care will not be affected by that choice. If you are eligible and choose to 
participate, the results of this study may help us provide better rehabilitation from stroke, 
and benefit individuals with stroke in the future. 
 
Thank you in advance for considering this request 
 
Sincerely, 
 
  
 
 

 
 
27
Phone Screening 
 
PATIENT INFORMATION: 
 
Name: ________________________________________________________________________________ 
 
Address: ______________________________________________________________________________ 
 
 
 ______________________________________________________________________________ 
 
Phone: _(____)_____________________     DOB: ________________ Date of Contact:________________ 
 
SUPPORT PERSON INFORMATION* 
*other than a physician, e.g., caregiver, family member, friend, nurse, etc. 
 
Name: ________________________________________________________________________________ 
 
Address: ______________________________________________________________________________ 
 
Phone: _(____)_____________________      Relationship: ______________________________________ 
 
Do we have your permission to contact this support person regarding the study?   
Y 
N 
 
Do you have reliable transportation to the medical center to attend up to 4  
 
Y 
N 
screening/testing sessions? 
 
Are you willing to make up to 10 half-day trips to the medical center over the course of  Y 
N 
the study?  
 
 
THE FOLLOWING QUESTIONS HELP US GAIN A BETTER UNDERSTANDING OF WHETHER YOU ARE 
LIKELY TO BENEFIT FROM CONSTRAINT-INDUCED MOVEMENT THERAPY: 
 
Have you experienced a stroke at least 6 months ago?    
 
 
 
Y 
N 
 
 
If yes, date of stroke?                                                                                                    _______________ 
 
Do you continue to experience difficulty moving your hand or arm on one  
 
Y 
N 
side of your body? 
 
Which arm/hand is weaker?                                                                                                   R            L 
 
Have you ever received constraint-induced movement therapy or modified 
  
Y 
N 
constraint-induced movement therapy for your weaker arm? 
 
Have you previously participated in a research project to help you regain  
  
Y 
N 
function in your weaker arm? 
 
If so, please describe: _____________________________________________________________________ 
 
Are you currently taking any medications to reduce tone in your weaker  
 
Y 
N 
hand/arm (e.g., Botox)? 
 
Do you use any devices to help you move your weaker arm/hand? 
 
 
Y 
N 
 
If so, please list: ______________________________________ How long used? _________________________ 

 
 
28
 
Do you have any surgeries planned in the next 3 months? 
 
 
 
Y 
N 
 
If your weaker hand is flat on a table, can you raise it without using the  
 
Y 
N 
shoulder or elbow? 
 
Please answer the following questions with your weaker forearm resting on the arm of a chair, wrist bent downward 
and hand hanging loosely over the front edge of the armrest. These questions apply only to your weaker arm. 
 
Can you bend your wrist back without lifting your forearm? 
 
 
 
Y 
N 
 
Can you open your hand?  
 
 
 
 
 
 
Y 
N 
 
Can you move your thumb away from the palm of your hand?  
 
 
Y 
N 
 
 
 
Now move your arm back on the armrest so that the palm of your hand is flat on the armrest and your fingers are 
hanging loosely over the front edge of the armrest. 
 
Can you lift at least two fingers while keeping your palm in contact with  
 
Y 
N 
the armrest? 
 
Answer the following questions about your weaker arm. It can be placed in any position that makes it easier for you to 
perform these tasks. 
 
Can you straighten your elbow? 
 
 
 
 
 
 
Y 
N 
 
Can you raise your arm at the shoulder? 
 
 
 
 
 
Y 
N 
 
Can you pick up a tennis ball and release it?  
 
 
 
 
Y 
N 
 
Can you pick up a washcloth and release it?  
 
 
 
 
Y 
N 
 
PAIN SCREEN 
 
Do you have pain that interferes with your life or activities?   
 
 
Y 
N 
 
If so, which word or words best describe the pattern of your pain?    
     
Continuous 
         Periodic (sometimes present)        
Momentary (lasting a short time) 
 
What kinds of things relieve your pain? ___________________________________________________________ 
 
___________________________________________________________________________________________ 
 
What kinds of things increase your pain? __________________________________________________________ 
 
___________________________________________________________________________________________ 
 
Please answer each of the following questions using the most appropriate rating on a scale of 0 to 10 where 0=no pain 
and 10=excruciating pain 
 
Which rating describes it as its worst during the past week?__________________________________________ 
 
Which rating describes it when it is at its least during the past week?  __________________________________ 
 
Which rating describes your pain on average during the past week?  ___________________________________ 

 
 
29
RCT In-Person Participant Screening Form 
 
Date:_________   
 
 
 
 
Evaluator _________________________ 
 
Participant’s name:_____________________________________    
DOB: ___________   
Gender:______  
Race: ___________ 
Contact person:_______________________  
Address:______________________________________________  
Phone:__________________ 
Pre-morbid handedness: __________ 
Side of Hemiparesis: ___________ 
Date of Stroke: ___________ 
 
Family and Friends (Required: at least four names and phone numbers of family and friends in 
case we cannot get hold of the patient) 
 
Name:___________________________ Relationship:__________ Phone:______________ 
 
Name:___________________________ Relationship:__________ Phone: ______________ 
 
Name:___________________________ Relationship:__________ Phone: ______________ 
 
Name:___________________________ Relationship:__________ Phone: ______________ 
 
 
ALL BULLETED INCLUSION CRITERIA MUST BE MET 
 
I. Active Movement 
 
1. Active Wrist and Finger Extension: 
Starting position: Participant’s forearm on supporting surface (in pronation) with hand hanging 
over edge of supporting surface allowing full wrist flexion or subject’s available range of motion.  
 
Participants must be able to actively extend wrist 10° from the starting position, extend or abduct 
the thumb at least 10°  from the starting position and extend the metacarpophlangeal and 
interphalangeal joints of at least 2 additional digits 10°. Picks up a washcloth from table and 
releases it. Must be able to perform each activity at least 3 times in 1 minute. Criteria can be met 
with a device such as Saebo Glove if participant is willing to use this device consistently during the 
trial.  

 
 
30
 
• Extension of wrist: 10° or more     
• Extension or abduction of thumb: 10° or more  
• Extension of MCP and PIP joints at least 2 additional digits: 10° or more 
 
 Does participant meet these criteria?  Y        N                                   
 
 
2. Active Shoulder Motion 
 
Participant must be able to actively flex and abduct shoulder to at least 45°. Note: For the purposes 
of this screening, the flexion may be exhibited from a position ranging from that of strict forward 
flexion toward scaption (which, on a horizontal plane, is half way between shoulder flexion and 
abduction); whereas, abduction may be exhibited from a position ranging from scaption to full 
abduction at the side of the body.   
Starting position: participant seated in chair with a back; UE resting in subject’s lap.  
 
• Flexion of shoulder: 45° or more      
• Abduction of shoulder: 45° or more  
 
 Does participant meet these criteria?   Y        N 
 
3. Active Elbow Extension 
 
All Groups – Participant must be able to actively extend at least 20° from the 90°  position. 
Starting position: Participant seated in chair with back; UE supported by tester in 90° of shoulder 
flexion (or maximal shoulder flexion possible if PROM is less than 90°) providing a gravity 
eliminated position for elbow extension and elbow flexed at 90°. 
 
• Extension of elbow: 20° or more from 90° flexed position  
 
 Does the participant meet this criterion?  Y        N  
 
 II. Passive ROM:  
 
• Shoulder flexion (90 degrees or more):  
• Shoulder Abduction (90 degrees or more):  
• Shoulder External Rotation (45 degrees or more):  
• Elbow Extension (-30 degrees contracture or less):  
• Forearm Supination (45 degrees or more from neutral):  
• Forearm Pronation (45 degrees or more from neutral):  
• Wrist Extension (to neutral or more):  
• MCP Extension (-30 degrees contracture or less):  
 
 Does the participant meet these criteria?   Y        N 

 
 
31
 
III. Vision/ Hearing: 
 
Participants must have adequate vision and hearing to perform testing (with correction). 
• Able to see MAL scales. 
• Hear instructions for testing. 
 
 Does the participant meet these criteria?  Y         N  
 
IV. Communication – Aphasia Criteria 
 
Participant must understand what therapist says (e.g., 1-step commands) and be able to indicate a 
response either verbally or through use of gesture/physical demonstration. Expressive language is 
not required. 
 
• Adequate communication ability to participate fully 
 
 Does the participant meet this criterion?  Y         N  
 
 
V. Motor Activity Log 
 
This criterion is most useful for identifying which participants with higher motor functioning are 
eligible to participate. There is no maximum level of motor ability for the study, but participants 
must exhibit non-use of the weaker arm (score less than 2.5 on the QOM portion of the MAL). When 
non-use is obvious and motor impairment is pronounced, you need not administer MAL.  
 
• MAL QOM less than 2.5 
 
 Does the participant meet these criteria?  Y         N  
 
 
VI. Pain 
 
Potential participants will be given the option to self-exclude if they have pain that would be 
significantly aggravated by participation in the protocol. Consider missed days in carrying out 
everyday tasks due to pain and excessive discomfort. 
 
VII. Anti-Spasticity Agents: 
 
Participants receiving Botox injections may be scheduled after 12 weeks from when the Botox 
injection was administered. If the participant is using other antispasticity agents such as oral 
Baclofen, then that information will be noted but will not used as inclusion / exclusion criteria. 
 
• More than 12 weeks from last Botox injection at start of trial 

 
 
32
 
Are you currently using Baclofen, Dantrium or any other anti-spasticity agents?  Y         N 
 
If so, which one? _____________ 
 
If botox, date of last injection? _____________ 
 Does the participant meet these criteria?  Y         N  
 
 
VIII. Administer 9-hole peg test 
 
If participant qualifies, see whether he/she falls in higher or lower functioning group. Stratification 
will be based on the participant’s ability to complete placement of any number of pegs on the 9-hole 
peg test within the allotted time (120 seconds). 
 
Higher group: can place ANY number of pegs (1-9) 
Lower group: cannot place any pegs 
 
 Which group is the participant assigned to?  ____________ 
 
IX: Additional Questions 
                                                                                                                                              (circle one) 
Are you able to maintain standing balance for 2 minutes; using UE for  
support if needed without the assistance of another person?                                              Y              N 
 
Are you able to independently and safely transfer to/from the toilet and  
manage clothing/hygiene?                                                                                                   Y              N 
 
Are you able to independently stand from a sitting position?                                             Y             N 
 
Do you plan to use a device during the trial (e.g., Saebo)?                                                Y              N 
 
X: Summary and Planned Follow-up: 
 
 
 
 
 
 
XI: If enrolled… 
 
Randomization Group? ____________ 
 
Date of Pretest:____________ 
 
Date of Post-test:___________ 
 
Date of 6-month follow-up: ___________ 

 
 
33
 
Treatment materials – CI therapy 
 
Checklist  
 
Note: Bolded items are separate sheets within the treatment packet to be completed 
 
Prior to Treatment (after pre-test) 
1. Provide the activity monitors to participants and demonstrate use. 
2. Instruct them to wear the activity monitors on both arms for 2 days before 
treatment to establish a baseline of arm use.  
3. Make sure participant knows to charge them overnight every night. 
4. Instruct participant to watch CIMT videos on YouTube. Give them the link. 
 
Treatment Day –1 (TD 1)  
1. Turn video camera on & show participant ID, treatment day, date, and group 
2. Complete Treatment Received Form 
3. Introduce the Treatment Contract by reading/explaining each component of 
the therapy. Briefly present the research. 
● discuss the need for massed practice with the weaker arm and limited 
use of the stronger arm to drive brain plasticity. 
● discuss how quality of life improvements relate directly to the amount of 
use for daily activities, regardless of motor ability. 
4. Home Achievement Record portion of Treatment Contract.  
● Compile list of daily activities done on both weekdays and weekends 
(one list) 
● Photocopy daily activities list prior to categorizing level of involvement of 
the weaker arm in each task (10 copies). Provide 1 copy to client to 
complete prior to next session.  
● Discuss involvement of the weaker arm in each task with problem-solving.  
5. Caregiver contract. Provide instruction to family member/caregiver on problem-
solving approach. (“You’ll notice that I used a particular approach to help clients 
come up with solutions to some of the barriers to using the weaker arm.”) 
● 
“Say” – They come up with a plan. No questioning. 
● 
“Do” – They try it out 
● 
“Check” - To note what worked and what didn’t. Revise the plan. 
6. Ask participant if he/she watched the CIMT videos on YouTube. If they have not 
yet, assign as homework. 
7. Ask participant about adverse events during previous session(s) and fill out 
Adverse Event Reporting Form if need be 
8. Donn the mitt 

 
 
34
9. Perform ~9 shaping tasks—document on Task List, Shaping Data Sheets, and 
Shaping Graphs (1 per task) 
10. Administer the full MAL-all 28 items using the How Well Scale only (add to MAL 
spreadsheet) 
11. Turn video camera off and add comments to Therapist Treatment Recording 
Log  
12.  Store the video on the encrypted hard drive under the correct group and 
session subfolder  
 
 
Treatment Day- 2 (TD 2)  
1. Turn video camera on & say participant ID, treatment day, and group 
2. Check the mitt time and record it on the Task List; donn the mitt. If mitt wear time 
is low, problem-solve compliance as needed. 
3. Administer a half MAL using the How Well Scale only (record responses on MAL 
spreadsheet) 
4. Review the Home Achievement Record with the patient 
5. Perform ~9 additional shaping tasks (different from those on TD 1)—document on 
Task List, Shaping Data Sheets, and Shaping Graphs (1 per task) 
6. Explain the Home Skill Assignment List (HSA) and select the 10 items 
7. Give the patient the next Home Achievement Record form 
8. Ask participant about adverse events and fill out Adverse Event Reporting Form if 
need be 
9. Turn video camera off and add comments to Therapist Treatment Recording Log 
10.  Store the video on the encrypted hard drive under the correct group and 
session subfolder  
11. Ask participant if he/she watched the CIMT videos on YouTube. If they have 
not yet, assign as homework. 
 
 
Treatment Day- 3 (TD 3-5, 7-10)  
1. Turn video camera on & say participant ID, treatment day, and group 
2. Check the mitt time and record it on the Task List; donn the mitt. If mitt wear time 
is low, problem-solve compliance as needed. 
3. Administer a half MAL using the How Well Scale only (record responses on MAL 
spreadsheet) 
4. Review the HSA 
5. Review the Home Achievement Record with the patient 
6. Repeat the 9 shaping tasks from TD1/TD2 (alternating between treatment days); 
can now consider shaping the tasks –document on Task List, Shaping Data 
Sheets and Shaping Graphs 
7. Select the 10 items for the Home Skill Assignment (HSA) list 
8. Give the patient the next Home Achievement Record form 

 
 
35
9. Ask participant about adverse events and fill out Adverse Event Reporting Form if 
need be 
10. Ask participant if he/she watched the CIMT videos on YouTube. If they have 
not yet, assign as homework. 
11. Turn video camera off and add comments to Therapist Treatment Recording 
Log 
12.  Store the video on the encrypted hard drive under the correct group and 
session subfolder 
 
Treatment Day- 6 (TD 6)  
1. Turn video camera on & say participant ID, treatment day, and group 
2. Check the mitt and record it on the Task List; donn the mitt. If mitt wear time is 
low, problem-solve compliance as needed. 
3. Administer a full MAL – all 28 items using the How Well Scale only (record 
responses on MAL spreadsheet) 
4. Review the HSA  
5. Review the weekend Home Achievement Record with the patient 
6. Repeat the 9 shaping tasks from TD2; can now consider shaping the tasks—
document on Task List, Shaping Data Sheets and Shaping Graphs  
7. Select the 10 items for the Home Skill Assignment (HSA) list 
8. Give the patient the next Home Achievement Record form 
9. Ask participant about adverse events and fill out Adverse Event Reporting Form if 
need be 
10. Ask participant if he/she watched the CIMT videos on YouTube. If they have 
not yet, assign as homework. 
11. Turn video camera off and add comments to Therapist Treatment Recording 
Log 
12.  Store the video on the encrypted hard drive under the correct group and 
session subfolder 
 
 
How to reset mitt device 
1. Unscrew 4 outer edge corners (Red Arrows) 
2. Hold down black button for ~5 seconds (Blue Arrow) 
3. Re-screw 4 outer edge corners  
 

 
 
36
 
 
 
 
 
 
 
 
 
 
 
 
 
 
MAL in follow-up 
MAL How Well administered with problem solving weekly for 1st month via phone. 
20 min. each. (4 times total) 
● Record responses on MAL spreadsheet 
 
 

 
 
37
Description of Therapy 
 
Constraint Induced Movement Therapy or CI therapy is thought to work because it has been shown to 
produce a large "rewiring" of the brain; that is, after treatment, a larger part of the brain is involved in 
producing movement of the weaker arm than before therapy.  It also has the effect of overcoming a 
strong tendency not to use the weaker arm (“learned nonuse”) that develops in the early post-stroke 
period. 
 
Research has shown that patients can "learn" to improve the motor ability of the weaker parts of their 
bodies and thus cease to rely exclusively or primarily on the stronger parts. For this learning and 
rewiring to occur, two things have to happen:  
1. Intensive training of the weaker arm in the clinic. This will occur through intensive training of 
the weaker arm and hand in the laboratory for 3 hours a day for 10 days.   
2. Use of the weaker arm for daily activities (more than the stronger arm) OUTSIDE the clinic. 
This is linked to structural changes in the brain and improved quality of life. Research has 
shown that these improvements are absent when improved motor function does not carry over 
to daily life. Three things will help you carry-over in-lab improvements to your daily 
activities. 
a.  Restraint of the stronger arm in a padded mitt for a large number of waking hours 
over the treatment period in the laboratory and at home.   
b. The procedures involved in use of the mitt will be outlined in a Treatment Contract 
established by you and the therapist at the beginning of treatment.   This contract is 
used to identify specific daily tasks that your weaker arm will perform and times when 
the mitt will be worn.  Safety is always the first consideration when determining the 
appropriate times for use of the weaker arm and the use of the mitt on the stronger arm.  
For example, if you require the use of a quad cane for safe walking, then the mitt 
would be removed when walking to ensure maximal safety when the quad cane is 
used. As part of this contract, you will be asked to complete a Home Achievement 
Record that focuses on the use of the weaker arm in your home and on the use of the 
mitt outside the laboratory.   
c. A home practice program (30 minutes daily) will be devised for you to carry out 
with your weaker arm when you are out of the clinic. 
 
Obtaining the Best Results  
 
You must be willing to work diligently during your treatment program. If portions of the therapy are 
dropped, the treatment has been found to be much less effective. Also, it would be harder for us to 
show definitive results from this study when people deviate from the study protocol (similar to 
studying the relative effectiveness of different medicines when they are not taken as prescribed). If 
you are having difficulty keeping up with the protocol, please let your project therapist know.  A 
solution can be worked out to help you achieve the most from the therapy and minimize deviations 
from the prescribed therapy.  
 
 

 
 
38
Treatment Contract 
 
I agree to the following treatment expectations: 
• 
I will attempt to use only my weaker arm for nearly all activities outside the clinic 
(listed in the Home Achievement Record form), including social situations.  I will 
attempt to use my weaker arm alone in all these activities, even if I had previously 
been using only my stronger arm for some of those tasks.  
 
• 
The only times that I will involve my stronger arm in my daily activities are if my 
safety could in any way be affected or for two-handed tasks. 
 
 Activities for which I can remove my mitt: 
_______________________________________________________ 
 
• 
I will wear the mitt on my stronger arm for a target 10 hours/day to break the habit of 
relying too much on my stronger arm for daily activities.  
 
• 
I will not remove the mitt at any time or for any task for which I have agreed to wear 
it, EXCEPT under 3 conditions: 1) if it could negatively affect my safety, 2) for two-
handed tasks, and 3) for tasks involving water. 
 
• 
If I need to reschedule a therapy session, I will call as soon as possible and no later 
than 24 hours in advance.  I will plan to arrive on time to all therapy sessions. 
 
• 
I will practice 10 activities of importance to me with my weaker hand for a total of 30 
minutes per treatment day (Home Skill Assignment). 
 
Goals for Treatment (what you’re working towards): 
 
1. _____________________________________________________________ 
 
2. _____________________________________________________________ 
 
3. _____________________________________________________________  
 
                                                                             
________________________       
___________________________ 
Signature of Patient  
 
  
Signature of Therapist 
 
 

 
 
39
Caregiver Contract 
 
 
 
      
I agree to assist with providing CI therapy in the following ways: 
 
- 
I will allow my family member to take ownership and responsibility for the treatment.  
 
- 
I will assist with a task by serving as a “second arm” to enable my family member to 
avoid using the stronger arm during the treatment period for certain tasks discussed in 
the Home Achievement Record. 
 
- 
I will relinquish my "caregiver hat" and will not perform any activities that my family 
member has agreed to accomplish with the weaker hand, even when my family 
member appears to be struggling.  
 
- 
I will only assist with upper extremity tasks if safety is a concern or if my assistance will 
provide additional opportunities for my family member to use the weaker arm (e.g., 
serving as a "second arm"). When assistance with a task is required I will allow my 
family member to solve the problem using the "Say," "do," "check" approach: 
• 
Say: What else could you try? 
• 
Do: Let your family member try the solution, even if you don’t think it will work.  
• 
Check: What worked? How can the plan be revised for better success? 
 
- 
I may provide reminders for my family member to engage in therapy tasks if he or she 
has indicated that they would be helpful (e.g., reminders to do Home Skill 
Assignments). 
 
- 
I understand that the treatment will be extremely challenging and I will be supportive 
and encouraging. 
 
- 
I will praise my family member's effort at using the weaker hand, especially during tasks 
that are difficult. 
 
- 
I will be open to simple adaptations in the home if they enable my family member to use 
their weaker arm more frequently (such as using plastic dishware temporarily). 
 
- 
I understand that using the weaker arm may result in more spills and that this is a 
necessary step toward improving function of the weaker arm.  I will be supportive when 
this happens.  
 
- 
I agree to attend therapy sessions when possible. 
 
 
________________________        
__________________________ 
Signature of Therapist 
 
 
 
Signature of Caregiver 

 
 
40 
Home Achievement Record of Treatment Contract 
 
Subject ID:  __________________________   Date: ______/______/________    Day (circle)   M   T   W   Th  F  Sat  Sun                           
Therapist:_________________      
 
DESCRIBE ACTIVITY 
 
I USED …….. ( check all that apply) 
Mitt 
ON 
  
 
Affected 
Arm  
Both 
 Arms 
Help 
Needed 
Comments 
 
Push self up out of bed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
41 
DESCRIBE ACTIVITY 
I USED …….. ( check all that apply) 
Mitt 
ON 
  
 
Affected 
Arm  
Both 
 Arms 
Help 
Needed 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DESCRIBE ACTIVITY 
 
I USED …….. ( check all that apply) 

 
 
42 
Mitt 
ON 
  
 
Affected 
Arm  
Both 
 Arms 
Help 
Needed 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
43 
Potential Home Practice Tasks  
 
 

 
 
44 
 

 
 
45 
 
 

 
 
46 
 

 
 
47 
 

 
 
48 
 

 
 
49 
 

 
 
50 
 

 
 
51 
 
 

 
 
52 
Home Practice Recording Log 
 
Subject ID:___________________________  Date _______/_______/________  Day  M  T  W  Th  F  Sat  Sun   
 
 
You should practice Home Skills Assignments for at least 30 minutes per day. 
 
NO. 
 
Activities or components of activities to be tried (i.e., 
washing hands includes rinsing hands, getting soap, 
drying hands, etc.)…... 
Attempted 
Y/N 
Number 
Times/Day 
 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
53 
Motor Activity Log Treatment Record 
 

 
 
54 
Motor Practice Recording Forms 
 
Feedback Graph 
 
SID:   
 
 
 
 
 
 
Date:   
 
 
 
Name:  
 
 
 
 
 
 
Day:   
 
 
  
Trainer:  
 
 
 
 
 
 
Task:   
 
 
 
 
 
 
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
  
  
  
  
  
  
  
  
  
  
  
 
 
 
 
  
  
  
  
Time / No. of Repetitions 
1
2
3
4
5
6
7
8
9
10

 
 
55 
Task List    SID ________________________ 
Task 
Day 
 1 
2 
3  
4 
5 
6 
7  
8 
9 
10 
Total 
Date 
 
 
 
 
 
 
 
 
 
 
 
Repetitions 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mitt use time 
(hours) 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
56 

 
 
57 
Video Recording Log 
 
Treatment Day:  Comments about recording (i.e. session completely recorded, battery died, etc.) 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
 

 
 
58 
Treatment materials – Gaming CI therapy Groups 
 
Checklist Self-Gaming 
 
Note: Bolded items are separate sheets within the treatment packet to be completed 
 
Prior to Treatment (after pre-test) 
 
1. Provide the activity monitors to participants and demonstrate use.  
2. Instruct them to wear the activity monitors on both arms for 2 days before treatment to 
establish a baseline of arm use.  
3. Make sure participant knows to charge them overnight every night. 
4. Provide the smart watch to participants and demonstrate use (give them the instructions to 
take home with them).  
5. Instruct them to wear the watch on the less affected arm for 2 days before treatment to 
establish a baseline of “normal” arm movement counts.  
6. Have them record the values on the watch right before going to bed on the Limb Activation 
Log. 
7. Instruct participant to watch CIMT videos on YouTube. Give him/her the link. 
 
In-clinic Treatment Day 1 (2 hours) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Only record the required activities for review for each session, turning the camera off after 
each activity  
3. Complete Treatment Received Form 
4. Review 4 components of intervention: intensive practice through game, computerized MAL, 
smart watch, Transfer Package of carry-over techniques. Emphasize that the game is only 
part of the therapy and that the other components are at least as important. The other 
components drive the brain plasticity. (~10 min) 
5. Instruction in game play and customization of game to individual.  (~30 minutes) 
● Occurs in home on participants’ own schedule.  
● 1.5 hours per day on 10 treatment days. Participants are encouraged to break this down 
into at least 3 separate play sessions per day (15-30 min sessions are optimal). 
● Tell the participant to record their amount of game play each day on the Game Log 
● Write down the randomly generated Game ID on one of the site business cards and 
instruct the participant to keep this with them and bring it to every visit (this is how you 
will access their game data) 
● Instruction on hot spot set-up 
6. Instruction in use of smart watch (~5 min). Have client record the daily count on the Limb 
Activation Log each night before going to bed 
7. Introduce the Treatment Contract by reading/explaining each component of the therapy. 
Briefly present the research. (15 min) 
● discuss the need for massed practice with the weaker arm and limited use of the stronger 
arm to drive brain plasticity. 
● discuss how quality of life improvements relate directly to the amount of use for daily 
activities, regardless of motor ability. 

 
 
59 
8. Home Achievement Record portion of Treatment Contract. (45 min) 
● Compile list of daily activities done on both weekdays and weekends (one list) 
● Photocopy daily activities list prior to categorizing level of involvement of the weaker 
arm in each task (10 copies). Provide 1 copy to client to complete prior to next session.  
● Discuss involvement of the weaker arm in each task with problem-solving.  
9. Explain the Home Skill Assignment List (HSA) and select 10 items (15 min) 
10. Ask participant if he/she watched the CIMT videos on YouTube. If he/she has not, assign as 
homework. 
11. Ask participant about adverse events and fill out Adverse Event Reporting Form if need 
be 
12. Add comments to Therapist Treatment Recording Log 
13.  Store the video on the encrypted hard drive  under the correct group and session subfolder 
 
Game Play 
1. TOTAL PLAY TIME SHOULD BE 15 HOURS OVER 3 WEEKS. 
2. Occurs in home on participants’ own schedule. 1.5 hours per day on 10 treatment days. 
Participants are encouraged to break this down into at least 3 separate play sessions per day 
(15-30 min sessions are optimal).  
3. Missed game play should be made up during off days. 
 
In-clinic Treatment Days ~Days 2, 3, 4 (1 hour) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Check game play compliance  
a. Click on Report Generator App (cannot be opened behind firewall) 
b. A black box pops up that says “Input User ID”  
c. Enter the participant’s Game ID under the “Input User ID” prompt (this ID is found 
on the participant’s business card) 
d. Hit Enter 
e. Report is generated (it works best if the computer you’re working from has Excel) 
3. Check compliance with smart watch. Review daily movement counts/problem-solve if low 
use. 
4. Review in-game MAL with problem-solving. 
5. Review Home Achievement Record with problem-solving. 
6. Home Skill Assignment, 10 items (may be same or different than 1st HSA). 
7. Remind participant about computerized MAL for next 4 weeks. 
8. Ask participant about adverse events and fill out Adverse Event Reporting Form if need 
be 
9. Ask participant if he/she watched the CIMT videos on YouTube. If he/she has not, assign as 
homework. 
10. Turn video camera off and add comments to Therapist Treatment Recording Log 
11.  Store the video on the encrypted hard drive under the correct group and session subfolder 
 
 
Follow-up 
1. MAL administered through REDCap survey or mail if no internet access weekly for 4 
weeks. 
 

 
 
60 
Checklist Tele-Gaming 
 
Note: Bolded items are separate sheets within the treatment packet to be completed 
 
Prior to Treatment (after pre-test) 
 
1. Provide the activity monitors to participants and demonstrate use.  
2. Instruct them to wear the activity monitors on both arms for 2 days before treatment to 
establish a baseline of arm use.  
3. Make sure participant knows to charge them overnight every night. 
4. Provide the smart watch to participants and demonstrate use (give them the instructions to 
take home with them).  
5. Instruct them to wear the watch on the less affected arm for 2 days before treatment to 
establish a baseline of “normal” arm movement counts.  
6. Have them record the values on the watch right before going to bed on the Limb Activation 
Log. 
7. Instruct participant to watch CIMT videos on YouTube. Give him/her the link. 
 
In-clinic Treatment Day 1 (2 hours) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Complete Treatment Received Form  
3. Review 4 components of intervention: intensive practice through game, computerized MAL, 
smart watch, Transfer Package of carry-over techniques. Emphasize that the game is only 
part of the therapy and that the other components are at least as important. The other 
components drive the brain plasticity. (~10 min) 
4. Instruction in game play and customization of game to individual.  (~30 minutes) 
● Occurs in home on participants’ own schedule.  
● 1.5 hours per day on 10 treatment days. Participants are encouraged to break this down 
into at least 3 separate play sessions per day (15-30 min sessions are optimal). 
● Tell the participant to record their amount of game play each day on the Game Log 
● Write down the randomly generated Game ID on one of the site business cards and 
instruct the participant to keep this with them and bring it to every visit (this is how you 
will access their game data) 
● Instruction on hot spot set-up 
5. Instruction in Bluejeans teleconferencing & give participant the Bluejeans Tip Sheet 
6. Instruction in Hotspot Setup 
7. Instruction in use of smart watch (~5 min). Have client record the daily count on the Limb 
Activation Log each night before going to bed. 
8. Introduce the Treatment Contract by reading/explaining each component of the therapy. 
Briefly present the research. (15 min) 
● discuss the need for massed practice with the weaker arm and limited use of the stronger 
arm to drive brain plasticity. 
● discuss how quality of life improvements relate directly to the amount of use for daily 
activities, regardless of motor ability. 
9. Home Achievement Record portion of Treatment Contract. (45 min) 
● Compile list of daily activities done on both weekdays and weekends (one list) 

 
 
61 
● Photocopy daily activities list prior to categorizing level of involvement of the weaker 
arm in each task (10 copies). Provide 1 copy to client to complete prior to next session.  
● Discuss involvement of the weaker arm in each task with problem-solving.  
10. Explain the Home Skill Assignment List (HSA) and select 10 items (15 min) 
11. Ask participant if he/she watched the CIMT videos on YouTube. If he/she has not, assign as 
homework. 
12. Ask participant about adverse events and fill out Adverse Event Reporting Form if need 
be 
13. Turn video camera off and add comments to Therapist Treatment Recording Log 
14.  Store the video on the encrypted hard drive under the correct group and session subfolder 
 
Game Play 
1. TOTAL PLAY TIME SHOULD BE 15 HOURS OVER 3 WEEKS. 
2. Occurs in home on participants’ own schedule. 1.5 hours per day on 10 treatment days. 
Participants are encouraged to break this down into at least 3 separate play sessions per day 
(15-30 min sessions are optimal).  
3. Missed game play should be made up during off days.  
 
Video consultation Day 2 (1 hour) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Check game play compliance 
a. Click on Report Generator App (cannot be opened behind firewall) 
b. A black box pops up that says “Input User ID”  
c. Enter the participant’s Game ID under the “Input User ID” prompt (this ID is found 
on the participant’s business card) 
d. Hit Enter 
e. Report is generated (it works best if the computer you’re working from has Excel) 
3. Check compliance with smart watch. Review daily movement counts/problem-solve if low 
use. 
4. Review in-game MAL with problem-solving. 
5. Review Home Achievement Record with problem-solving. 
6. Home Skill Assignment, 10 items (may be same or different than 1st HSA). 
7. Ask participant about adverse events and fill out Adverse Event Reporting Form if need 
be 
8. Ask participant if he/she watched the CIMT videos on YouTube. If he/she has not, assign as 
homework. 
9. Turn video camera off and add comments to Therapist Treatment Recording Log 
10. Store the video on the encrypted hard drive under the correct group and session subfolder 
 
In-clinic Treatment Days ~Days 3, 5, 8 (1 hour) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Check game play compliance 
a. Click on Report Generator App (cannot be opened behind firewall) 
b. A black box pops up that says “Input User ID”  
c. Enter the participant’s Game ID under the “Input User ID” prompt (this ID is found 
on the participant’s business card) 

 
 
62 
d. Hit Enter 
e. Report is generated (it works best if the computer you’re working from has Excel) 
3. Check compliance with smart watch. Review daily movement counts/problem-solve if low 
use. 
4. Review in-game MAL with problem-solving. 
5. Review Home Achievement Record with problem-solving. 
6. Home Skill Assignment, 10 items (may be same or different than 1st HSA). 
7. Ask participant about adverse events and fill out Adverse Event Reporting Form if need 
be. 
8. Ask participant if he/she watched the CIMT videos on YouTube. If he/she has not, assign as 
homework. 
9. Turn video camera off and add comments to Therapist Treatment Recording Log 
10. Store the video on the encrypted hard drive under the correct group and session subfolder 
 
Video consultation Days 4, 6, 7, 9, 10 (20 min) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Review in-game MAL with problem-solving. (10 min) 
a. Click on Report Generator App (cannot be opened behind firewall) 
b. A black box pops up that says “Input User ID”  
c. Enter the participant’s Game ID under the “Input User ID” prompt (this ID is found 
on the participant’s business card) 
d. Hit Enter 
e. Report is generated (it works best if the computer you’re working from has Excel) 
3. Review Home Achievement Record with problem-solving (5 min) 
4. Home Skill Assignment, 10 items (may be same or different than 1st HSA). (5 min) 
5. Remind participant about computerized MAL for next 4 weeks. 
6. Ask participant if he/she watched the CIMT videos on YouTube. If he/she has not, assign as 
homework. 
7. Ask participant about adverse events and fill out Adverse Event Reporting Form if need 
be 
8. Turn video camera off and add comments to Therapist Treatment Recording Log 
9. Store the video on the encrypted hard drive under the correct group and session subfolder 
 
Follow-up 
1. MAL administered via phone call weekly for 4 weeks.  Therapist is to complete the MAL in 
follow-up document each time.  
 
 
 
 

 
 
63 
Description of Therapy 
 
What is CI Therapy? 
Constraint Induced Movement Therapy or CI therapy is thought to work because it has been shown to 
produce a large "rewiring" of the brain; that is, after treatment, a larger part of the brain is involved in 
producing movement of the weaker arm than before therapy.  It also has the effect of overcoming a 
strong tendency not to use the weaker arm (“learned nonuse”) that develops in the early post-stroke 
period. 
 
Research has shown that patients can "learn" to improve the motor ability of the weaker parts of their 
bodies and thus cease to rely exclusively or primarily on the stronger parts. For this learning and 
rewiring to occur, two things have to happen:  
1. Intensive training of the weaker arm. This will occur through playing the Recovery Rapids 
video game in your home for 1.5 hours per day for 10 days.   
2. Use of the weaker arm for daily activities (more than the stronger arm) OUTSIDE the clinic. 
This is linked to structural changes in the brain and improved quality of life. Research has 
shown that these improvements are absent when improved motor function does not carry over 
to daily life. Three things will help you carry-over in-lab improvements to your daily activities 
(i.e., change your habit of always using the stronger arm). 
a. A smart watch that will record your activity with the weaker arm. The goal will be to 
dramatically increase the number of arm movements made with your weaker arm over 
the course of the intervention.   
b. A Treatment Contract that will identify specific daily tasks that your weaker arm 
will perform each day.  Safety is always the first consideration when determining the 
appropriate times for use of the weaker arm (e.g., you may not want to use a cane in 
the weaker hand). As part of this contract, you will be asked to complete a Home 
Achievement Record each day to check your progress with building new habits of 
using the weaker arm in your home. 
c. A home practice program (30 minutes daily) will be devised for you to carry out 
with your weaker arm when you are out of the clinic. 
 
Obtaining the Best Results  
You must be willing to work diligently during your treatment program. If portions of the therapy are 
dropped, the treatment has been found to be much less effective. Also, it would be harder for us to 
show definitive results from this study when people deviate from the study protocol (similar to 
studying the relative effectiveness of different medicines when they are not taken as prescribed). If 
you are having difficulty keeping up with the protocol, please let your project therapist know.  A 
solution can be worked out to help you achieve the most from the therapy while minimizing 
deviations from the prescribed program.  
 
 

 
 
64 
Treatment Contract 
 
I agree to the following treatment expectations: 
• 
I will use only my weaker arm for nearly all activities outside the clinic (listed in the Home 
Achievement Record form), including social situations.  I will attempt to use my weaker arm 
alone in all these activities, even if I had previously been using only my stronger arm for some 
of those tasks.  
 
• 
The only times that I will involve my stronger arm in my daily activities are if my safety 
could in any way be affected or for two-handed tasks. 
 
 
Activities for which I should use my stronger arm:  
___________________________________________________________ 
 
• 
I will wear the smart watch on my weaker arm for a target 10 hours/day to break the habit of 
relying too much on my stronger arm for daily activities. I will record the number of 
movements made by my weaker arm each night with the goal of exceeding the number of 
movements typically made with my stronger arm.  
 
• 
If I need to reschedule a therapy session, I will call as soon as possible and no later than 
24 hours in advance. I will plan to arrive on time to all therapy sessions. 
 
• 
I will practice 10 activities of importance to me with my weaker hand for a total of 30 
minutes per treatment day (Home Skill Assignment). 
 
Goals for Treatment (what I'm working towards): 
 
1. __________________________________________________________________________ 
 
2. __________________________________________________________________________ 
 
3. __________________________________________________________________________  
 
 
                                                                                 
________________________              
___________________________ 
Signature of Patient 
 
 
  
Signature of Therapist 
 
 
 
 

 
 
65 
Caregiver Contract 
 
 
 
      
I agree to assist with providing CI therapy in the following ways: 
 
- 
I will allow my family member to take ownership and responsibility for the treatment.  
 
- 
I will assist with a task by serving as a “second arm” to enable my family member to 
avoid using the stronger arm during the treatment period for certain tasks discussed in 
the Home Achievement Record. 
 
- 
I will relinquish my "caregiver hat" and will not perform any activities that my family 
member has agreed to accomplish with the weaker hand, even when my family 
member appears to be struggling.  
 
- 
I will only assist with upper extremity tasks if safety is a concern or if my assistance will 
provide additional opportunities for my family member to use the weaker arm (e.g., 
serving as a "second arm"). When assistance with a task is required I will allow my 
family member to solve the problem using the "Say," "do," "check" approach: 
• 
Say: What else could you try? 
• 
Do: Let your family member try the solution, even if you don’t think it will work.  
• 
Check: What worked? How can the plan be revised for better success? 
 
- 
I may provide reminders for my family member to engage in therapy tasks if he or she 
has indicated that they would be helpful (e.g., reminders to do Home Skill 
Assignments). 
 
- 
I understand that the treatment will be extremely challenging and I will be supportive 
and encouraging. 
 
- 
I will praise my family member's effort at using the weaker hand, especially during tasks 
that are difficult. 
 
- 
I will be open to simple adaptations in the home if they enable my family member to use 
their weaker arm more frequently (such as using plastic dishware temporarily). 
 
- 
I understand that using the weaker arm may result in more spills and that this is a 
necessary step toward improving function of the weaker arm.  I will be supportive when 
this happens.  
 
- 
I agree to attend therapy sessions when possible. 
 
 
________________________        
__________________________ 
Signature of Therapist 
 
 
 
Signature of Caregiver 
 
 

 
 
66 
Home Achievement Record of Treatment Contract 
 
Subject ID:  __________________________   Date: ______/______/________    Day (circle)   M   T   W   Th  F  Sat  Sun                           
Therapist:_________________      
 
DESCRIBE ACTIVITY 
 
I USED …….. ( check all that apply) 
  
Affected 
Arm  
Both 
 Arms 
Help 
Needed 
Comments 
 
Push self up out of bed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
67 
 
DESCRIBE ACTIVITY 
 
I USED …….. ( check all that apply) 
  
Affected 
Arm  
Both 
 Arms 
Help 
Needed 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
68 
 
DESCRIBE ACTIVITY 
 
I USED …….. ( check all that apply) 
  
Affected 
Arm  
Both 
 Arms 
Help 
Needed 
Comments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
69 
In-clinic Treatment Schedule 
 
453 W 10th Ave. Columbus, OH 43210 
 
To help us obtain the most meaningful study results, we would greatly appreciate your efforts to 
reschedule missed appointments or game play time. This will ensure that all study groups get the 
same amount of total motor practice. Your participation will help us learn whether an in-home 
therapy can lead to gains in motor functioning that are as large as with more costly in-clinic 
therapies. We really appreciate your contribution to science! 
 
Event 
Date 
Time In 
Time Out 
Location 
Pretest (2 hours)  
 
 
 
In Clinic Day 1 
(2 hours) 
 
 
 
 
In Clinic Day 2 
(1 hour) 
 
 
 
 
In Clinic Day 3 
(1 hour) 
 
 
 
 
In Clinic Day 4 
(1 hour) 
 
 
 
 
Post Test (2 
hours) 
 
 
 
 
6 Month Follow 
Up 
 
 
 
 
 
 
 
 

 
 
70 
In-home game play schedule 
 
Date 
Time In 
Time Out 
Completed? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
71 
Date 
Time In 
Time Out 
Completed? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Home Practice Recording Log is the same form as for the CI therapy group. 
 
 

 
 
72 
Game Gestures Key 
 
 
 
 

 
 
73 
 
 

 
 
74 
Video Recording Log Self-Gaming: 
 
In-Clinic 
Treatment Day: 
Comments about recording (i.e. session completely recorded, battery died, 
etc.) 
1 
 
2 
 
3 
 
4 
 
 
 
 

 
 
75 
Video Recording Log Tele-Gaming: 
 
In-Clinic/ 
Teleconsultation 
Treatment Day 
Comments about recording (i.e. session completely recorded, battery died, 
etc.) 
1 (clinic) 
 
2 (tele) 
 
3 (clinic) 
 
4 (tele) 
 
5 (clinic) 
 
6 (tele) 
 
7 (tele) 
 
8 (clinic) 
 
9 (tele) 
 
10 (tele) 
 
 
 

 
 
76 
MAL in Follow-up Recording Form for Tele-Gaming Group: 
 
 
 
 

 
 
77 
 
Limb Activation Instructions (Pebble Watch): 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
If the screen is showing the time, press “select” 
• 
Toggle down to the app “Hands On” 
• 
Push the select button to select the Hands On app (this is the limb activation) 
• 
When you are using the device, make sure notifications are on (see 
above picture for how to turn them on/off) 
• 
IMPORTANT: In order for the notifications to work (vibrate after 10 
minutes of inactivity), you must click the “back” button and you will wear it 
with the time visible, not the amount of movements 
• 
However, if you prefer to have the daily count visible, that is fine too, 
the notifications just will not work 
• 
Wear the watch during all of your waking hours for the duration of 
your participation in the study 
• 
The watch will need to be charged every night 
o The charger will insert into a USB on any computer and connect to 
the back of the watch 
o The display on the watch will say “charging” when it’s 
connected properly 
•
To reset the app, hold down the select button for a few seconds and
release and everything will be set back to 0 
 
 
 
 
 
 

 
 
78 
Pebble Watch Log:  
 
 Please record the daily count from your watch each night before you go to bed 
 The first two days (baseline days) you will wear the watch on your unaffected arm, which 
will give you a goal for daily counts of your affected arm during the intervention  
 
Date: 
Baseline  
_______
_ 
 
Baseline  
_______
_ 
 
_____
__ 
 
_____
__ 
 
_____
__ 
 
_____
__ 
 
_____
__ 
 
_____
__ 
 
_____
__ 
 
_____
__ 
Daily 
Count: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date: 
 
___
___
_ 
 
____
___ 
 
 
 
 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
 
____
___ 
Daily 
Count
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
79 
Treatment Materials – Usual Care 
 
Traditional Rehabilitation Protocol 
 
Guiding Principles: 
● Participants will receive the intervention on 4 visits that total 5 hours of participant/therapist contact. 
The 4 visits will be dispersed across the 3 weeks as evenly as possible. Ideally, the first 2 visits will 
occur during week 1 and the second 2 visits will be administered on weeks 2 and 3. 
● The intervention will incorporate activities that are typically used in clinical settings for rehabilitation. 
● The activities are designed to meet the specific needs of the participant (e.g., work to improve their 
body structure challenges, activity limitations, and participation goals). 
● The protocol is standardized regarding activity categories, activity selection, activity intensity target 
level, and progression principles yet will be tailored to the participants’ specific needs and goals. 
● The amount of time dedicated to each activity category is specified below. It is expected that several 
trials of a given activity category may be accomplished during this time frame and it is expected that 
the number of trials may vary between participants based on their movement and endurance 
capabilities.  
● For the active procedures of neuromuscular re-education, functional training, and progressive 
strengthening, the target for exercise intensity is 4 (somewhat hard) on the Borg CR10 Rating of 
Perceived Exertion Scale. Therapists should also assure that activities are conducted with high 
quality. 
● When designing a clinical activity, therapists will select from a list of activities and grade the difficulty 
of the activity so that the participant is working at a level 4 on the Borg CR10 Rating of Exertion Scale. 
In subsequent visits, therapists should adjust the activity grade (up or down) to achieve that same 
level 4 of the Borg CR10 Scale. 
● A home program will be designed for all participants on the first visit. This home program will consist 
of theraband strengthening exercises to be done over a 15 minute time period twice daily (total of 
30 minutes each day) except on the days that they come into the laboratory for treatment. Therapists 
will design this program based on the participant’s skill with the exercises and the appropriate level 
of exertion (4 on the Borg CR10 Scale). Therapists will provide written instructions on these exercise 
and will review and modify the exercise program, as appropriate, on subsequent clinic visits (i.e., 
visits 2-4).  
Allocation of treatment time – The first treatment session will be 2 hours in length and subsequent 
treatment sessions will each be 1 hour in length. 
 
 
 

 
 
80 
Treatment Day 1 
Activity 
category 
Evaluate for 
therapeutic needs 
Neuromuscular 
re-education 
Functional 
Training 
Progressive 
Strengthening 
Establish 
and teach 
home 
program 
Time 
dedicated 
to this 
activity 
25 minutes  
 20 minutes 
25 minutes 
25 minutes 
25 minutes 
 
Other Treatment Days 
Activity 
category 
Review and 
adjust, as 
appropriate, 
home program 
Neuromuscular re-
education 
Functional 
Training  
Progressive 
Strengthening 
 
Time dedicated 
to this activity 
 10 minutes 
10 minutes 
25 minutes  
15 minutes 
 
Clinical Activity Description: Neuromuscular re-education (20 minutes TD1; 10 minutes TD2-4) 
Description: ICD definition: (ICD 97112)Neuromuscular re-education of movement, balance, coordination, 
kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities Examples include: 
Biofeedback, PNF, manual facilitation, sensory priming.  
 
These activities will be used to “prime” the motor responses and promote more coordinated and 
appropriate muscle responses during the functional training to follow. 
 
Clinical Activity Description: Functional Training (25 minutes all treatment days) 
Description: Functional training will focus around 4 categories of activities that have high relevance for 
functional use of the upper extremity (dexterity, interpersonal reaching, extrapersonal reaching, and overhead 
reaching). Each category of activities will be carried out for approximately 5 minutes, allowing another 5 
minutes for switching between task categories. Participants will be seated for all activities and patients 
encouraged to keep their trunk against the back of the chair to promote proper posture. Assistive devices such 
as orthoses, taping or bandages can be used. Rest periods can be provided as much as needed. 
 
1. Dexterity – Participants will use the more-affected hand to engage in various manipulation tasks for 
approximately 5 minutes of the functional training period during each of the treatment days. The 
specific manipulation task selected for that day will correspond with manipulation task in need of 
improvement for and preferred by that participant. The task should also be moderately challenging for 
that individual and leads to physical exertion rating of a 4 on the Borg CR10 Scale.  
Examples: picking up small objects (e.g., coins, paper clips, checkers) off of a table, buttoning a shirt, 
flipping playing cards.  
 
2. Inter-personal Space Reaching – Participants will use the more-affected arm to engage in reaching and 

 
 
81 
manipulation tasks relatively close to their body (e.g., requiring less than 45 degrees of shoulder 
flexion).  These tasks will be less likely to involve a great deal of trunk rotation and/or reaching across 
midline. 
Examples: using a spoon to move beans from one bowl to another, moving a belt through belt loops, 
moving ping pong balls from one container to another. 
3. Extra-personal Space Reaching – Participants will use the more-affected arm to engage in reaching 
and manipulation tasks relatively far away from their body (e.g., requiring between 45 and 90 degrees 
of shoulder flexion and approaching full extension of the elbow).  These tasks will be more likely to 
involve trunk rotation and reaching across midline. 
Examples: wiping off a counter, setting a table with eating utensils. 
Overhead Reaching - Participants will use the more-affected arm to engage in reaching tasks toward 
a target that is held by a therapist and placed overhead (e.g., requiring greater than  90 degrees 
shoulder flexion and approaching full extension of the elbow).   
Examples: combing hair with a brush, blow drying hair, putting a hat on/off, placing objects on a 
high shelf. 
 
Clinical Activity Description: Progressive Strengthening Activities (25 minutes TD1; 15 minutes TD 2-
4) 
Description: Strengthening should emphasize shoulder flexion, Shoulder Abduction (with elbow extension or 
90o of flexion), Shoulder Extension (with elbow extension or 90o of flexion), and Shoulder External Rotation 
(90o elbow flexion). Each movement will be carried out according to the description taken from the GRASP 
exercise program with no theraband or with the color of theraband providing the level of resistance 
corresponding to a level 4 on the Borg CR10 Scale and that allows good quality of movement. During the 
session, therapists will select a number of repetitions that correspond to moderate exertion (rating of 4 on the 
CR10 exertion scale) and will assign that number of repetitions for the home exercise program to be carried 
out until the next visit. The number of repetitions will be progressed as appropriate for that patient and 
corresponding with strength gains while maintaining Borg level 4 and completing the program in 30 minutes. 
 
 
 

 
 
82 
Borg CR10 Rating of Perceived Exertion Scale 
 
Rating 
Description 
0 
Nothing at all 
0.5 
Very, very light 
1 
Very light 
2 
Fairly light 
3 
Moderate 
4 
Somewhat hard 
5 
Hard 
6 
 
7 
Very hard 
8 
 
 
 
 

 
 
83 
Traditional Therapy Checklist (Group 4) 
 
Note: Bolded items are separate sheets within the treatment packet to be completed 
 
Prior to Treatment (after pre-test) 
1. Provide the activity monitors to participants and demonstrate use.  
2. Instruct them to wear the activity monitors on both arms for 2 days before treatment to 
establish a baseline of arm use. 
3. Make sure the participant knows to charge them overnight every night.  
 
Treatment Day 1 (TD 1) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. Complete Treatment Received Form 
3. 30 minutes of evaluation of affected upper extremity function. 
4. 20 minutes of neuromuscular re-education. Complete Treatment Log Day 1.  
5. 25 minutes of functional training. Complete Treatment Log Day 1. 
6. 25 minutes of progressive strengthening. Complete Treatment Log Day 1.  
7. 20 minutes of teaching home program. Complete Treatment Log Day 1.  
8. Ask participant about adverse events and fill out Adverse Event Reporting Form if need be. 
9. Turn video camera off and add comments to Therapist Treatment Recording Log 
10. Store the video on the encrypted hard drive under the correct group and session subfolder   
 
Treatment Day 2 (TD 2) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. 10 minutes of neuromuscular re-education. Complete Treatment Log Day 2.  
3. 25 minutes of functional training. Complete Treatment Log Day 2. 
4. 15 minutes of progressive strengthening. Complete Treatment Log Day 2.  
5. 10 minutes of reviewing and updating home program. Complete Treatment Log Day 2.  
6. Ask participant about adverse events and fill out Adverse Event Reporting Form if need be. 
7. Turn video camera off and add comments to Therapist Treatment Recording Log 
8. Store the video on the encrypted hard drive under the correct group and session subfolder   
 
Treatment Day 3 (TD 3) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. 10 minutes of neuromuscular re-education. Complete Treatment Log Day 3.  
3. 25 minutes of functional training. Complete Treatment Log Day 3. 
4. 15 minutes of progressive strengthening. Complete Treatment Log Day 3.  
5. 10 minutes of reviewing and updating home program. Complete Treatment Log Day 3.  
6. Ask participant about adverse events and fill out Adverse Event Reporting Form if need be. 
7. Turn video camera off and add comments to Therapist Treatment Recording Log 
8. Store the video on the encrypted hard drive under the correct group and session subfolder   
 
 
 

 
 
84 
Treatment Day 4 (TD 4) 
1. Turn video camera on & say participant ID, treatment day, and group 
2. 10 minutes of neuromuscular re-education. Complete Treatment Log Day 4.  
3. 25 minutes of functional training. Complete Treatment Log Day 4. 
4. 15 minutes of progressive strengthening. Complete Treatment Log Day 4.  
5. 10 minutes of reviewing and updating home program. Complete Treatment Log Day 4.  
6. Ask participant about adverse events and fill out Adverse Event Reporting Form if need be. 
7. Turn video camera off and add comments to Therapist Treatment Recording Log 
8. Store the video on the encrypted hard drive under the correct group and session subfolder   
 
Video Recording Log is the same as for the Self-Gaming Group. 

85 
Usual Care Treatment Log 
 
 
TREATMENT DAY 1 
(2 hours) 
Date:__________ 
TREATMENT DAY 2 
(1 hour) 
Date:__________ 
TREATMENT DAY 3 
(1 hour) 
Date:__________ 
TREAMENT DAY 4 
(1 hour) 
Date:__________ 
Evaluation 
(30 minutes) 
 
N/A 
 
N/A 
 
N/A 
Neuromuscular re-
education 
(20 minutes) 
Level: 
Activities 
completed: 
 
(10 minutes) 
Level:  
Activities 
completed: 
(10 minutes) 
Level: 
Activities 
completed:  
(10 minutes) 
Level: 
Activities 
completed:  
Functional Training 
(one of each: 
dexterous, reaching 
close, far, high as 
possible) 
(25 minutes) 
Activities 
completed: 
1.  
2. 
3. 
4. 
(25 minutes) 
Activities 
completed:  
(25 minutes) 
Activities 
completed:  
(25 minutes) 
Activities 
completed:  
Progressive 
Strengthening 
(25 minutes) 
Activities 
completed:  
(15 minutes) 
Activities 
completed:  
(15 minutes) 
Activities 
completed:  
(15 minutes) 
Activities 
completed:  
Teach, review home 
program 
(Shoulder 
strengthening  
Theraband GRASP, 
Pang, 2006 
flexion                     (20 minutes) 
abduction 
extension 
external rotation  
(progress resistance of band and 
increasing repetitions as appropriate 
targeting 30 min of exercise at Borg 
level 4).  
(10 minutes) 
Review and update HEP  
(10 minutes) 
Review and update HEP 
(10 minutes) 
Review and update HEP 
Participant ID: ______________ 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
Moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 
Intensity 
easy 
moderate 
hard 

 
 
86 
Assessment Measures 
 
 
 
 
 
 
 
 

 
 
87 
 

 
 
88 
 
 
 

 
 
89 
 

 
 
90 
Reasons for non-use 
 
1 – I used the unaffected arm entirely 
 
 
2 – Someone else did it for me 
 
 
3 – I never do that activity, with or without the help of someone else 
 
 
4 – I sometimes do that activity, but did not have the opportunity since 
the last time I answered these questions 
 
 
5 – Other 
 
 

 
 
91 
How Well Scale 
 
0 – The weaker arm was not used at all for that activity 
 
(never) 
 
 
1 – The weaker arm was moved during that activity, but was not helpful 
 
(very poor) 
 
 
2 – The weaker arm was of some use during that activity, but needed 
some help from the stronger arm, moved very slowly, or with 
difficulty  
 
(poor) 
 
 
3 – The weaker arm was used for the purpose indicated, but the 
movements were slow or were made only with some effort 
 
(fair) 
 
 
4 – The movements made by the weaker arm were almost normal, but 
not quite as fast or accurate as normal 
 
(almost normal) 
 
 
5 – The ability to use the weaker arm for that activity was as well as 
before the stroke 
 
(normal) 
 
 
 

 
 
92 
Treatment Received Form 
 
Participant ID: ________________ 
 
Please indicate the treatment you have received targeting your affected upper extremity 
prior to enrolling in this research study (check all that apply):  
 Inpatient Rehabilitation 
 Outpatient Rehabilitation  
 Botox  
 Baclofen pump 
 Other research studies  
 Other: 
__________________________________________________________________ 
 
 
 

 
 
93 
Participant ID:   
 
Date: 
 
 
Testing Session:   
 
Affected Hand (circle one): Right 
Left 
 
9 HOLE PEG TEST  
 
Directions for Participant: 
“You are going to take the pegs from the container, one by one, and place them into 
the holes on the board, as quickly as possible. You must then remove the pegs from the 
holes, one by one, and replace them back in the container. You may use the hand not 
being tested to hold the edge of the container to provide stability. You will have 120 
seconds to complete this task. Do you have any questions?” 
 
Notes to tester: 
 Test should be administered to both hands, starting with the unaffected hand 
 The board should be placed at the participant’s midline 
 Participant is allowed up to 120 seconds to complete the task 
 Document the number of pegs placed and the total time per hand 
 If the participant cannot complete the activity, number of pegs placed should be 
documented as 0 and total time should be documented as 120+ 
 
UNAFFECTED HAND 
AFFECTED HAND 
 
Number of pegs placed:      
Number of pegs placed: 
Total Time (min:sec):  
 
Total Time (min:sec):   
 
 
 

 
 
94 
 
 
 

 
 
95 
 
 

 
 
96 
 

 
 
97 
Demographic Information 
 
Subject #: ______ 
 
Current date: _____ 
 
Date of Stroke:________  (stroke that resulted in hemiparesis if more than 1 stroke) 
 
Birthdate:  __________ 
 
Handedness prior to stroke:  Right   Left   Ambidextrous 
 
More affected side:  Right   Left 
 
Etiology:  
Ischemic  
Hemorrhagic     Unknown 
 
Race/ethnicity:   ______________ 
 
Gender:       Male  
 Female 
Other 
 
Years Education (e.g., H.S.=12; college degree = 16): ________ 
 
Who lives with you? (circle all that apply):    
Spouse     
Child(ren) 
 Adult Child(ren)     
Caregiver 
     Parent(s) 
 
 
 
 
OSU RESEARCH STAFF ONLY BELOW THIS LINE 
 
Rural:      Yes   No 
 
SES:    
 
 

 
 
98 
Therapist Observations to be collected on LAST day of treatment:  
 
Involvement of Caregiver (check one): 
 
_______ 0 – Limited caregiver support (caregiver not present, did not engage in treatment, or 
doesn’t help much at home) 
 
_______ 1 – Supportive caregiver (s) – assists when appropriate and encourages independence 
when possible 
 
_______ 2 – Enabling caregiver(s) – assists too frequently  
 
Level of Emotional Support in Family Environment (check one):  
 
_______ 0 – little emotional support or frequent interpersonal conflict 
 
_______ 1 – more supportive than not  
 
 

 
 
99