Establishing the Functional Viability and Dose-response of Duck, Duck Punch: A Stroke Rehabilitation Computer Game
Phase: NA
Conditions: Rehabilitation, Recovery of Function, Stroke
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: 
 
Establishing the functional viability and dose-response of Duck, Duck Punch: A Stroke Rehabilitation 
Computer Game 
 
PRINCIPAL INVESTIGATOR: 
 
Michelle L. Woodbury, PhD, OTR/L 
 
NCT03053492 
 
 
 

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1.0 
Objectives / Specific Aims 
 
We developed a prototype Kinect-based post-stroke rehabilitation game called Duck Duck Punch (DDP).  
The overall goal of this NIH Small Business Initiated Research (SBIR) Phase II project is to determine its 
functional viability and dose-response.  
 
This goal will be achieved by conducting three studies (thus requiring 3 informed consent forms).  
 
Study 1: DDP Intervention 
 
Aim 1: Evaluate whether home use of DDP for 6 weeks improves post-stroke arm motor ability.  
Rationale: In our preliminary studies, we demonstrated that stroke survivors feasibly used DDP to self-
direct high-repetition arm movement sessions. However we do not know if the observed gains in arm motor 
skills could be attributed to DDP (custom designed) versus a commercially available, “off the shelf” 
computer game. Hypothesis: The unique design of DDP elicits healthy movement repetitions at an optimal 
level of challenge therefore, will yield greater gains in post-stroke arm ability when compared to a 
commercially available “off the shelf” computer game that may elicit un-healthy movement patterns and/or 
lower amounts of movement repetitions. Design: Single blind, parallel-arm with blocked randomization 
according to motor impairment level. N=66 subjects with primary diagnosis of post-stroke arm paresis will 
participate in dose-matched, self-directed, in-home play of either (1) DDP or (2) a commercially available 
computer game over 6 weeks. Analysis: Between-group comparison of pre- to post- changes in arm 
movement abilities for each impairment strata.  
 
Aim 2: Examine the dose-response relationship by relating movement repetitions to arm motor 
skills.  
Rationale: Commercialization of this product requires an understanding of the dose-response relationship 
across different levels of stroke severity to guide treatment programs. Design: Segmented regression and 
growth mixture models will be used to relate the number of arm movement repetitions to treatment 
response in patient subgroups separated by level of motor impairment.  
 
 
Study 2: Focus Groups 
 
Aim 3: Determine the treatment validity of the DDP report as a measure of impairment and 
response. 
Rationale: Functional viability requires that DDP be relevant to the post-stroke recovery process. At the 
end of each DDP session, a report summarizes impairment measurements made with the Kinect. It is not 
known if this report is useful (valid) for informing treatment decisions across the rehabilitation continuum. 
Design: DDP is currently being used in several in- and out-patient stroke rehabilitation facilities. For this 
study, we will obtain feedback from focus groups of (1) therapists (2) survivors who have played DDP and 
(3) caregivers of those who have played DDP regarding the validity of the DDP report to inform treatment 
decisions. Information gained from these consumer focus groups will inform re-design of the DDP report 
to make it more clinically relevant and useful.  
 
Impact: There is a need to develop and market new options for extended post-stroke arm movement 
practice. This project will yield data regarding DDP’s effect on recovery, dosing, and the translatability of 
its performance report. Thus, this Direct-to-Phase-II SBIR will set the stage for a future definitive study to 
enable clear decisions regarding the clinical utility and commercialization of DDP to therapists and stroke 
survivors. 
 
 
 

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Study 3: Joint Range of Motion Validation 
In addition, a small, third study will be conducted; its Aim is to validate a new method of measuring 
shoulder and elbow joint ranges of motion. This new method involves using the Microsoft Kinect to 
track arm motion. We have written new software codes to calculate joint ranges of motion using Kinect 
recordings of arm motion, we expect that these new codes provide accurate measurements, but have no 
evidence to support our expectation. Therefore, for this 3rd study we will enroll 10 neurologically healthy 
individuals and 10 individuals with stroke (at the conclusion of the parent study) for a single 1-hour 
evaluation session in which the Kinect joint angle measurements will be compared to the same joint angle 
measurements made with our state of the art laboratory-based PhaseSpace Motion Capture (MoCap) 
system. This 3rd study will have its own informed consent.  The concurrent validity of the Kinect and MoCap 
measures will be studied with intraclass correlational analyses. If the Kinect-based measures are similar 
to the MoCap measures (within an acceptable 10 degree measurement error), then the Kinect measures 
will be incorporated into the outcomes of the parent study.  
 
Study 4: E-learning for At-Home Paretic Arm Use 
 
Aim 4: Test the feasibility of an e-learning module to elicit patient self-directed paretic arm use in 
their home 
 
Rationale: Results from recently concluded large stroke rehabilitation clinical trials clearly indicate a 
disparity between paretic arm use during (1) therapy vs. (2)  at home or in the community. That is, patients 
safely accomplish hundreds of paretic arm movement repetitions during a structured therapy session. Yet, 
they fail to translate motor skills from clinic to home. As documented by wrist-worn activity monitors, 
patients rarely move the paretic arm during non-structured (non therapist initiated) real-world 
home/community activities despite having had intensive in-clinic arm rehabilitation. Reasons for this 
disparity include patients’ self-reported lack of knowledge regarding optimal ways to care for him/herself 
after therapy has ended. It is likely that the current therapy model of in-clinic therapist-guided arm 
movement practice inhibits patients’ development of self-management skills by reinforcing reliance on the 
therapist’s guidance for arm use. Thus, patients leave therapy without the skills to self-direct their own long 
term recovery. That is, they do not know how to, on their own, overcome the challenges to using their 
paretic arm during real world activities at home and in the community.  In efforts to address this problem, 
we created an online learning module within MUSC’s Moodle e-learning platform for stroke survivors 
designed to bridge the gap between the clinic and home. The purposes of this e-learning module are 
to (1) provide information about stroke motor recovery to elicit cognitive learning for self-management and 
(2) coach stroke survivors during at-home paretic arm use via therapist-patient teleconferences to elicit 
psychomotor learning for self-management.  
 
Design: This is a proof of concept study to ascertain the feasibility of stroke survivors ability to access 
and benefit from the Moodle e-learning module.  
 
Impact: if proven feasible, these data will support a future, properly powered clinical trial to test the e-
learning module’s impact on stroke patients’ self-management skills. At the current time, e-learning is not 
used to bridge the clinic-to-home transition in stroke rehabilitation. Thus, this research is highly innovative, 
and has the potential to completely transform post-rehabilitation care for stroke survivors.  
 
 
2.0 
Background 
 
Background: Stroke is a problem nationally, but especially in the southeastern USA, a region known as 
the “stroke belt” where stroke incidence is high and age of stroke onset is low. The vast majority, >75%, of 
stroke survivors experience paresis of one arm/hand that does not resolve acutely. Long-term arm 
movement impairment restricts independence with self-care and vocational activities, increases caregiver 
burden and reduces quality of life. Although rehabilitation improves outcomes, systematic financial 

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pressures increasingly limit its duration. Unfortunately, this is happening at a time when strong evidence 
is emerging that traditional therapy programs do not provide adequate amounts of movement practice 
needed for motor recovery. Thus, there is a need for innovative technology to augment traditional stroke 
rehabilitation programs in a way that can provide the necessary movement practice within the constraints 
of current rehabilitation practice. 
  
To meet this need, we developed a prototype Kinect-based post-stroke rehabilitation game called Duck 
Duck Punch (DDP). While maintaining the appeal of a game, DDP has a therapeutic focus because its 
unique design elicits an arm motor recovery process consistent with evidence-based 
stroke rehabilitation principles. The player moves his/her physical arm to control an 
avatar arm to reach and “punch” virtual ducks. Custom features allow tailoring of game 
difficulty to match a player’s impairment level so that the player seeks to accomplish 
optimally challenging movement goals. By design, the avatar does not respond to 
atypical arm motions, which encourages the player to trial and error a variety of 
motions until implicitly learning the more normal strategy. Thus, unlike most 
commercially available “off the shelf” games, success requires “therapist approved” 
healthy arm motions. Success motivates continued game play for extended practice 
of healthy motions. Therapists can integrate DDP into in-clinic or in-home therapies 
for additional quasi-supervised movement practice and receive a performance report 
that quantifies and monitors progress toward recovery goals. Further development of 
this report will enable its integration into a billable rehabilitation program. 
 
We licensed DDP and formed a company, Recovr, which has received investment 
funding for initial start-up and market research. Of note, DDP has also received FDA 510(k) Clearance to 
“support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned 
reach exercises 
for the upper extremities.” In a funded NIH/NIGMS CTR pilot project, we established the technical merit 
and feasibility of DDP as a tool to augment inpatient, outpatient and home-based stroke rehabilitation by 
increasing therapist- and patient-directed movement practice opportunities.  Very promising results 
motivated the current project that seeks to test the functional viability of DDP and determine its commercial 
potential. 
A. SIGNIFICANCE 
A.1. Stroke incidence in rural southeastern states is high, and age of stroke onset is low, thus 
burdening the region. The southeastern US states is known as the “stroke belt” where stroke incidence 
is unusually high and the age of stroke onset is unusually low.1 The overwhelming majority of stroke 
survivors, >75%, exhibit upper extremity (UE) hemiparesis, and only 15% will recover fully.2, 3 Residual 
UE impairment is closely linked to long-term disability4 and reduced quality of life.5 With such a large cohort 
of young disabled stroke survivors, there are significant financial and resource burdens on healthcare 
throughout the region.6 
 
A.2. Rehabilitation can reduce stroke-related disability by improving UE movement skill. Decades 
of research in neuro- and rehabilitation science provides clear evidence of the potential for recovery, even 
many years after stroke.7-9 The existing data strongly suggest that the damaged brain possess remarkable 
ability to reorganize neural networks contributing to functional recovery.10  Stroke rehabilitation provides 
behavioral training to harness learning-dependent neural plasticity and promote functional UE motor skill 
recovery.9, 11   
 
A.3. UE motor recovery requires substantial practice of appropriately challenging movement tasks. 
High numbers of movement repetitions drive neural reorganization in areas of the brain associated with 
improved skills.12-14  However, the greatest neuroplastic changes are associated with the repetition of new, 
progressively more challenging, skills rather than repetition of existing skills.15, 16 Repetitive practice of 
“new” motor skills means practicing movements for which an individual has partial but not complete 
A young stroke 
survivor playing 
Duck Duck Punch. 

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success, or, said differently, practicing movements that are neither too easy nor too difficult. Practice at 
the “just right” level of challenge optimizes the sensorimotor feedback available for learning by offering 
opportunity for implicit error detection and motor strategizing.17 This also means that the level of challenge 
must progress as the individual’s skill level increases.17, 18  
 
A.3. Stroke patients do not receive enough UE movement practice. There has been a failure to 
translate evidence-based guidelines into stroke rehabilitation. For example, several hundred movement 
repetitions/day are required for neural reorganization and behavioral change,14 however current stroke 
rehabilitation programs include ~32 movement repetitions/day.19  Therapy is further under-dosed because 
inpatient rehabilitation length of stay is usually capped at 15-20 days,20 with most patients receiving a total 
of ~20 sessions each lasting ~30 minutes.21 Young working-age stroke survivors, a group without uniform 
healthcare coverage, may have even shorter lengths of stay and less opportunity to practice. Furthermore, 
access to outpatient therapy is poor, especially in rural southeastern states like South Carolina, where 
>75% of the population must drive >30 minutes for specialized stroke services.22, 23  Clearly, there is a 
need for cost effective, high-dose, appropriately challenging UE movement rehabilitation options to reduce 
stroke disability and burden in this region.  
 
A.4. Interactive virtual reality technology can provide low-cost opportunities for UE movement 
practice. Virtual reality technology offers exciting possibilities for low-cost, accessible, and highly 
motivating therapy options to address the need for evidence-based doses of movement practice.24-27 
Gaming systems are divided into two categories; custom designs (e.g., Duck Duck Punch) or commercially 
available “off the shelf” systems.25, 28, 29 Gaming-assisted stroke rehabilitation is a young, rapidly growing 
field. Our team is comprised of experienced technology developers30-33 and stroke rehabilitation 
therapists.34-37 We argue that this partnership will ensure that technology developed by Recovr 
complements evidence-based practice by maintaining a therapeutic focus while remaining engaging.38, 39  
 
B. INNOVATION 
 
B.1. We developed, and licensed an innovative stroke rehabilitation game; Duck Duck Punch. We 
are among the first research teams with expertise in both stroke rehabilitation and computer 
science to leverage Microsoft Kinect skeletal tracking technology for retraining post-stroke UE 
movements.40 Duck Duck Punch (DDP) is an interactive game with an old time carnival theme. 
The patient sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical 
arm; reaching forward to “punch” virtual ducks. Custom features enable patients with all levels of 
impairment to play. Success motivates continued play, so that the user engages in high-repetition UE 
movement practice. Microsoft recognized our innovation when they awarded DDP 2nd place worldwide in 
the prestigious 2012 international Imagine Cup competition held in Australia. Impressively DDP stood out 
from a field of over 500 worldwide applicants, all of whom had proposed novel uses of the Kinect for 
healthcare.  
 
B.2. Why does the (very busy) field of rehabilitation computer gaming need DDP? DDP is unique 
because its design integrates scientifically based principles of post-stroke motor recovery. Specifically, 
DDP is uniquely designed to retrain a healthy movement pattern (forward reach) by constraining 
compensatory (atypical) trunk motions that may interfere with recovery. This is important because stroke 
impairs forward reaching skills. Instead of reaching forward by moving the arm away from the body by 
simultaneously extending the elbow and flexing the shoulder, patients inadvertently pull the paretic arm 
towards the body, i.e., the pathological “flexion synergy” characterized by  simultaneous elbow flexion and 
shoulder abduction/extension.41 When forward reach is impaired, individuals with stroke compensate by 
leaning forward to transport the hand to an object.42 Elbow extension motion is inversely related to trunk 
compensations.43 The ability to reach forward without compensation is an important indicator of recovery 
as it marks the threshold between categories of severe and moderate impairment36 and predicts quality of 
life.44  
 

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Current evidence-based rehabilitation principles specify that motor rehabilitation should promote recovery 
of healthy not compensatory movement patterns because compensatory 
trunk/arm movements are associated with maladaptive plasticity,45 
shoulder pain,46 and reduced potential for long term recovery.47  Therefore 
there is a need to retrain forward reach while discouraging trunk 
compensations. DDP specifically designed so as to assure that it elicits an 
arm movement pattern consistent with current evidence based principles 
of rehabilitation . Specifically, DDP is designed to constrain compensatory 
(atypical, unhealthy) trunk motions because the DDP shoulder avatar is 
fixed in space meaning that the avatar arm does not respond to patients’ 
attempts to use compensatory trunk motion to “punch” the target rather 
than reach forward with the arm. As shown in Figure 1, the avatar hand 
moves toward the target only when patient reaches forward using shoulder 
flexion-elbow extension not when he/she leans forward. Therefore, when 
a more “normal” strategy is used, the patient experiences the reward of successful game play to reinforce 
the movement strategy.   
 
In the very busy field of computer gaming for rehabilitation DDP stands out because of its therapist-like 
focus on training good quality forward reaching movements. Recent systematic reviews48,49 show that only 
13 studies have utilized the Kinect for stroke rehabilitation. The Kinect is controlled by body or limb motion 
rather than a controller and therefore is usable by severely impaired individuals who do not have the 
hand/finger recovery needed to grasp or push controller buttons. To our knowledge, only DDP40 and 3 
others50-52 track arm motion (rather than the hand) with the Kinect to retrain reaching motions, but DDP 
stands alone with its focus on healthy movement patterns only. 
 
DDP is designed to so that the difficulty of game play can be adjusted to match patients’ level of ability and 
facilitate post-stroke motor skill (re)learning that underlies recovery.15, 17 If a task is too difficult, meaning 
that the patient does not have enough skill to achieve the task goal, the patient will utilize compensatory 
trunk and/or arm movement strategies.42, 53 These atypical, poor quality motions, i.e., “learned bad-use”47 
may inhibit overall recovery. Therefore DDP was designed so that the difficulty of game play can be 
adjusted through (1) avatar arm scaling, shown in Figure 2 and (2) target selection, shown in Figure 3. By 
matching game difficulty to player’s ability DDP allows the person to experience a combination of both 
errors and success during repetitive practice54 thereby providing implicit and explicit  feedback to challenge 
the nervous system and promote learning of good quality motions.  
 
Figure 1:  A subject enrolled in the pilot 
study.  On day 1 (left) she continually 
attempted to lean forward to bring the 
avatar hand to the duck, however the 
avatar arm did not respond. On day 5 
(right) she had implicitly (re)learned a 
more normal movement strategy. 

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B.3. DDP provides rehabilitation options for individuals with 
moderate-severe UE impairment and very little hand recovery, an 
underserved group.  Only 25% of stroke survivors recover enough hand 
dexterity to grasp, release and manipulate objects during task practice 
rehabilitation sessions.55 This means that the vast majority of stroke 
survivors do not qualify for “gold-standard”56 task practice therapies. DDP 
provides an option for this underserved population (see Figure 4). This 
makes DDP very different from other computer games that are only 
appropriate for patients with mild impairment because patients must either 
grasp a controller (Wii)57 or utilize full arm range of motion to successfully 
play. 
 
PRELIMINARY STUDIES 
 
With NIH/NIGMS CTR funding, we conducted a preliminary study aimed at translating DDP out of our 
research laboratory and into clinical practice settings. Results are 
summarized here: N=20 inpatient stroke rehabilitation subjects, aged 31-
78 years and 4-53 days post-stroke enrolled. The aim was to test the safety 
and usability of DDP in the inpatient rehabilitation environment. We trained 
subjects’ caregivers to set up and operate DDP, and subjects’ played during 
non-therapy hours (evenings/weekends). Subjects self-directed DDP play 
for 
5-7 
days, 
21 
minutes/day, 
averaging 
219 
arm 
movement 
repetitions/session  with no adverse events, reports of pain, and or fatigue 
that interfered with regular inpatient rehabilitation. Figure 5 presents data 
from a representative subject. who was 6 days post-ischemic stroke with a 
baseline Fugl-Meyer Upper Extremity score of 25 (moderate-severe motor 
impairment). He played DDP while family members operated and coached 
the session. He engaged in 60-309 arm movement repetitions per day over 
6 days, with sessions of 9-28 minutes in duration. At the conclusion, the 
patient’s wife stated; “we are not computer people, but this was so easy and 
fun. Can we take it home?” 
 
N=20 community-dwelling stroke survivors were randomized to either DDP or a standard of care home 
exercise program (HEP). The aim was to document adherence because it is a critical factor contributing to 
the effectiveness of self-directed home based rehabilitation programs. Subjects and their caregivers 
randomized to the DDP group were trained to set up and operate DDP, and the control group was trained 
to carry out shoulder and elbow exercises illustrated in a standard of care HEP. A study therapist phoned 
all subjects daily. Wrist worn accelerometers documented adherence, defined as days and minutes per 
day engaged in the activity. In addition, accelerometry data were used to calculate the arm activity ratio, 
which is a measure of paretic arm use. Higher values indicate greater paretic arm use relative to non-
paretic arm use; values close to 1 indicate bilateral arm use. As reported in Table 1, the results were 
striking; DDP subjects demonstrated statistically greater adherence and paretic arm use.   
 
Figure 6:  A community-
dwelling stroke survivor who 
played DDP in her home.   
 
Days engaged  
range, median  
Minutes per day 
range, median 
Arm Activity Ratio 
range, median 
DDP 
n=10 
5-7, 7.00 
20.43-96.00, 
57.86  
1.49-9.11, 2.85 
HEP 
n=10 
0-7, 5.00* 
9.00-81.57, 
26.82*  
1.04-2.42, 1.90* 
Table 1: When compared to a standard home exercise program, community 
dwelling stroke survivors who played DDP exhibited statistically greater (as 
indicated by asterisks) days and minutes per day engaged in UE movement 
practice and greater arm activity ratios, indicating higher amounts of paretic 
arm vs. non-paretic arm movements. 
 

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The pilot funding enabled DDP installation at several rehabilitation 
hospitals: As shown in the photo, we have trained local stroke therapists to 
incorporate DDP into their rehabilitation sessions for in- and out-patients. We 
have developed and implemented a ~60 minute DDP training seminar that is 
eligible as a CEU course for South Carolina occupational and physical 
therapists. We also have designed a DDP instruction manual that provides 
detailed instructions for tailoring game difficulty using the virtual arm scaling and 
target selection features. The manual is continually updated based on 
therapists, survivors, and caregiver’s suggestions. Therapists have accepted 
DDP into their daily clinical routines and provided overwhelmingly positive 
support for our pilot work.. 
 
Preliminary Data Motivating Aim 2: In another pilot study we examined 
the evolution of elbow extension in   one participant who played DDP in 
our research laboratory 2-3 times per week, ~60 minutes per session, for 
4 weeks. Kinematic analysis on the first and last day of treatment showed 
that she gained 28° of elbow extension. However, repeated measures 
showed that the motor skill acquisition was not linear. Instead, the subject 
demonstrated progressively less elbow extension (greater flexion) over 
the first week. Gains in elbow extension did not occur until session 6. 
These data are interesting because they demonstrate a non-linear dose-
response relationship. This subject did not respond to the intervention 
until she had received approximately 5-6 hours of therapy. This is 
important information for a therapist or stroke survivor because when 
deciding how to incorporate DDP into a stroke rehabilitation program, the 
consumer (therapist or stroke survivor) requires this information to plan 
the frequency, length and dose of the program. 
 
Preliminary Data Supporting the use of a measure of Shoulder-Elbow Interjoint Coordination (IJC) 
as a primary outcome variable for Aim 2: The new dependent variable for Aim 2 will be shoulder-elbow 
interjoint coordination (IJC) which will be calculated as the Pearson’s correlation coefficient between the 
trajectories of shoulder elevation and elbow flexion.53, 58 Joint angles will be obtained through Euler 
decomposition of the relative segment orientations. Segment reference frames and Euler sequences are 
defined following ISB guidelines: shoulder elevation as the rotation of the humerus with respect to the 
thorax along the floating x-axis; elbow flexion as the rotation of the forearm with respect to the humerus 
along the humerus z-axis.59 A healthy individual performing a seated reach-to-target task would generate 
a coordinated increase of shoulder elevation with elbow extension (i.e., decrease of elbow flexion) which 
would be reflected in a correlation value = -1.00. Values = 0 indicate a 
decoupling of shoulder and elbow motion, while values = 1.00 
represent the shoulder elevation-elbow flexion movement pattern 
often observed in more severely impaired stroke survivors.  
 
1) The IJC can differentiate levels of post-stroke arm movement 
impairment: N=83 stroke survivors enrolled in an ongoing 
rehabilitation study were divided into 4 impairment levels according to 
the Fugl-Meyer Upper Extremity Assessment (FMA-UE) score (out of 
60 points)36: mild (FMA-UE>47, n=17), moderate (FMA-UE 32-47, 
n=29), moderate-severe (FMA-UE 16-31, n=29) and severe (FMA-
UE<16, n=11). Kinematics were recorded with a PhaseSpace motion 
capture system while participants performed a seated reach-to-target 
placed at midline and at 80% of arm’s length. IJC was calculated for 
the time window between the start of reach and the point at which the 
hand was closest to the target for all subjects. Results shown in Figure 9: IJC for mild, moderate, 
Figure 7:  An occupational 
therapist 
incorporates 
DDP into a therapy session 
at a local hospital.   
mild
moderate
moderate_severe
severe
-1
-0.5
0
0.5
1
correlation
Figure 9: ICJ index (correlation between 
shoulder elevation and elbow flexion) for
a seated reaching task. The horizontal axis
indicates stroke impairment level. 
Figure 8:  One subject’s evolution of 
voluntary elbow extension over 11 
DDP 60 minute sessions. These data 
suggest a non-linear dose-response 
relationship thus motivating Aim 2 
for the present proposal.  

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moderate-severe and severe groups were -0.92, -0.84, -0.26 and 0.28 respectively. A one-way ANOVA 
showed a main effect (F(3,79)=22.23, p<1E-9). Post-hoc multiple comparisons with Bonferroni correction 
showed a significant difference (p<0.01) between all impairment levels except between the mild and the 
moderate group (p=0.95).  
 
2) The IJC can be measured by the Kinect: N=4 stroke survivors played DDP in our PhaseSpace motion 
capture laboratory. We simultaneously collected Kinect and PhaseSpace data while subjects made 10 
reaches to a virtual target located at the center of the game window at approximately shoulder height. 
Shoulder elevation and elbow flexion joint 
angles were calculated then used to obtain 
IJC values. Figure 10 compares shoulder 
(dotted lines) to elbow (solid lines) joint angle 
trajectories obtained from the Kinect (black) 
to PhaseSpace (red) for one subject. Note 
the similarity between the joint angle 
trajectories. We then calculated an intraclass 
correlation coefficient  for the IJC obtained 
from the two systems for each reach. Figure 
11 shows the similar IJC values for subject 
#4’s 10 reaches. When group data were 
averaged, the IJCs for the 2 systems were 
strongly correlated ICC=0.94. These data 
show that the Kinect can reliably and validly measure IJC and therefore this variable can be used as DDP 
performance measure. 
 
3) The IJC, measured with the Kinect, shows change with DDP game 
play:  N=10 stroke survivors (aged 31-78 yrs, 4-53 days post stroke) played 
DDP in an inpatient stroke rehabilitation setting once/day x7 days. For every 
session of playing DDP we recorded the joint positions and segment 
orientations provided by the Kinect, and used them to calculate the IJC for 
each successful reach (i.e. each reach that resulted in hitting a virtual target). 
Data were averaged for the group and compared with a pairwise two-tailed 
t-test. Results (Figure 12) show a significant change in IJC (p = 0.002). 
Subjects also showed reduced upper extremity impairment (FMA-UE scores 
increased from 33.44 to 39.00, p=0.06) and increased motor function (Wolf 
Motor Function Test time to perform tasks reduced from 46.36 to 30.87 
seconds, 
p=0.02) 
thus 
suggesting 
that 
IJC 
data 
collected with the Kinect is a 
way to monitor participant 
progress.  
 
4) A change in IJC is related to gains in survivor’s self-
reported stroke recovery: N=10 stroke survivors played 
DDP at-home for one week. At the beginning and at the end 
of the program, we evaluated each participant by 
administering the Stroke Impairment Scale. IJC was 
measured with the Kinect. Figure 13 shows that changes in 
IJC were significantly correlated to changes in the perceived 
recovery (r=-0.71, p=0.02).  
 
 
 
Figure 12: Comparison of the IJC measured 
while playing DDP at the first and last day 
of a one-week study 
first day
last day
-1
-0.8
-0.6
-0.4
-0.2
0
0.2
0.4
0.6
0.8
1
IJC (correlation)

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3.0 
Intervention to be studied  
 
Study 1: DDP Intervention 
 
Aim 1: Evaluate whether home use of DDP for 6 weeks improves post-stroke arm motor ability.  
Aim 2: Examine the dose-response relationship by relating movement repetitions to arm motor 
skills. 
 
• 
Rationale: Preliminary studies demonstrated that stroke survivors feasibly used DDP to self-direct high-
repetition arm movement sessions. However, we did not test its usefulness at facilitating gains in arm 
motor skills compared to popular commercially available computer games. Commercialization of DDP, 
a computer game specifically designed for stroke patients, requires an understanding of its effect on 
post-stroke arm motor ability. Specifically, there is a need to understand how playing DDP may be 
more/less/equally beneficial as playing an off-the-shelf commercially available computer game.   
 
• 
Randomization to Treatment Groups: At the pre-treatment visit, after signing informed consent, the 
Fugl-Meyer Upper Extremity Assessment will be administered (see description below). Its summed 
score will be the basis for assignment to an impairment strata. Subjects within each stratum will be 
randomized to play DDP or a commercially available Kinect game, the Kinect Target Shoot.   
 
• 
Duck Duck Punch (DDP): We anticipate that DDP will improve motor skills because the difficulty of the 
game is matched to the player’s level of ability and then continually progressed 
so that there is an ongoing match between task-difficulty and patient-ability. By 
continually matching task-difficulty to current patient-ability, we will assure 
repetition of novel movements, akin to Nudo’s “skill training.16” Repetition of 
progressively more challenging movements is associated with greater levels of 
activity in neural networks supporting motor recovery when compared to 
repetition of “easy” movements.60 
 
• 
Kinect Target Shooting (KTS) was chosen as the comparison because both 
games 
require 
similar 
shoulder 
flexion/abduction 
and 
elbow 
extension/flexion movements. This is a commercially available Kinect-based 
game in the Sports Rivals package. Subjects will remain seated and utilize 
their affected UE to reach and point at targets. The only way to alter the 
difficulty of game play is to switch game levels between easy, moderate and 
expert levels. Although the game is called “target shooting”, the player does 
not hold a physical object in their hand. The “shooting” is accomplished by 
using one’s physical arm to move an on-screen cursor to a target, therefore, 
similar to DDP, the game can be played by patients who have not recovered 
hand dexterity.  
 
• 
Rationale for comparison of DDP to an “off the shelf” commercial game: We custom designed DDP 
with a focus on forward reaching movement quality because, by design, it does not reward (i.e., 
constrains) compensatory atypical motions that may interfere with recovery. We expect that subjects 
will be utilize compensatory motions when playing the commercially available KTS because it does not 
focus on movement quality. Subjects will be able to use atypical trunk or arm motions to play. This 
study is important because it is unknown if custom games like DDP actually are more effective at 
promoting recovery when compared to commercial games.48  It is possible that an “off the shelf” 
computer game is just as, or more effective at promoting motor recovery. If so, then there will be no 
need to continue to develop or commercialize DDP.   
 
• 
Rationale for comparison of DDP to another computer game rather than rehabilitation therapy: We 
chose to compare DDP to a commercial game rather than a standard of care therapy because enrolled 
Kinect 
Target 
Shooting: 
screen shot from a Microsoft 
marketing video 

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subjects will be at least 6 months post-stroke meaning that most will have completed their rehabilitation. 
As found in the EXCITE trial, less than 50% of the “usual and customary care” group who were an 
average of 6 months post-stroke, were participating in rehabilitation.9 We believe that the current 
standard of care at this time point post-stroke is a home exercise program (HEP) with little, if any, 
“regular” in-person therapy involving regular contact with a therapist. Home exercise programs are 
usually written and illustrated handouts61 although commonly provided, with notoriously low 
adherence62 in spite of the fact that stroke survivors understand the importance of 63 and know they 
should be motivated for home exercises. 64 Our preliminary study results compared DDP to a standard 
of care HEP. The results were consistent with the literature and clearly showed subjects in the HEP 
group had low adherence. We seek to compare DDP to another intervention with similar amounts of 
activity, i.e., an “active” control, so as to understand the effects of our custom game, with its focus on 
forward reach vs. another game that requires similar arm motions to play.  
 
• 
Dose: Dose will be matched across groups. All subjects will engage in 18 days (3 days per week over 
6 weeks) of DDP or the commercially available game. All subjects will be instructed to play the game 
for 60 minutes/day. It is likely that some subjects will choose to distribute this dose throughout a day. 
To assure matching does, custom software will be loaded onto the laptop that displays and records the 
duration of game play as it accumulates over a 24-hour period. Subjects will be instructed to “play the 
game until the timer shows that you have been playing for 60 minutes in a day.”  
 
• 
Rationale for the Dose: We chose this dose because it is similar to post-stroke arm rehabilitation 
programs having distributed practice schedules. For example, modified constraint therapy consists of 
15 total hours of treatment; 30-minute sessions, 3 days/week for 10 weeks.65 Similarly, UE functional 
task training consists of 18 total hours of treatment; 1 hour sessions, 3 days/week for 6 weeks.66 and 
impairment oriented training consists of 20 total hours of treatment; 1 hour sessions, 5 days/week for 
4 weeks.67 Because some participants may not be able/ may not choose to complete 60 minutes each 
day, the intensity of training (averaged amount of time per day) will be added as a covariate to the 
primary analysis. 
 
Study 2: Focus Groups: 
 
No intervention.  
 
Study 3: Joint Range of Motion Validation: No intervention 
 
Study 4: E-learning Intervention 
 
Aim 4: Test the feasibility of an e-learning module to elicit patient self-directed paretic arm use in 
their home 
 
Rationale: There is a need to empower stroke survivors’ post-rehabilitation skills for self-managing their 
own long term arm recovery. We created an e-learning module on MUSC’s Moodle e-learning platform for 
stroke survivors designed to bridge the gap between the clinic and home. The purposes of this e-
learning module are to (1) provide information about stroke motor recovery to elicit cognitive learning for 
self-management and (2) coach stroke survivors during at-home paretic arm use via therapist-patient 
teleconferences to elicit psychomotor learning for self-management.  
 
The e-learning course: Subjects will participate in a 4-week online course offered in MUSC’s Moodle 
Platform. Each week the course will offer a/an: 
(1) Lesson: The purpose of the weekly lessons are to provide subjects’ with information about stroke 
and stroke recovery. Lessons will include videos, readings, and/or Panopto-recorded lectures from 
a research team member (or other stroke rehabilitation expert). For example, subjects will learn 

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principles of activity dependent neural plasticity in order to motivate them to use the paretic arm 
more and discourage over use of the non-paretic arm.  
(2) Asynchronous discussion: The purpose of weekly discussions are to enable subjects to gain a 
deeper understanding of the week’s lesson and begin to apply the lesson to his/her own goals. The 
asynchronous discussion will occur via the course Discussion Board and be moderated by study 
team members.  
(3) Video teleconference meeting between the group of subjects and the study’s occupational 
therapist. The teleconference, conducted using Web-x within the Moodle course, will allow subjects 
to interact with each other and the therapist. They will discuss their own arm use goals, receive 
tips/pointers from the therapist for implementing home arm use, and engage in peer support with 
other survivors who are also seeking to use their paretic arm more.  
 
 
4.0 
Study Endpoints  
 
Study 1: DDP Intervention 
 
• 
Primary Outcome Measures:  
 
• 
The Fugl-Meyer Upper Extremity Assessment (FMA-UE) is a 33 item measure of upper 
extremity (UE) impairment; however, the 3 items testing reflex response will not be administered 
because they do not measure a voluntary movement construct.37 Each item will be scored on a 3 
point rating scale (0=unable to perform, 2=near normal performance), item ratings will be summed 
and reported out of 60 points so that larger numbers indicated less UE impairment.   
 
• 
The Wolf Motor Function Test (WMFT) is a 15 item measure of UE functional ability. Performance 
of each item will be timed (seconds) and the average time to perform items will be reported so that 
lower values indicate greater UE function. 
 
• 
Two kinematic variables will quantify the effect of the intervention on UE motor skills; (1) shoulder 
flexion-elbow extension interjoint coordination and (2) trunk displacement.43 Kinematic data 
will be collected from 2 motion capture systems: (1) a PhaseSpace motion capture system in the 
research laboratory and (2) the Microsoft Kinect, a skeletal tracking sensor that used to operate 
DDP.  
 
• 
Laboratory based kinematic analysis: Subjects will be seated on a backless stool in a standardized 
starting position. Using their affected UE, subjects will perform 2 trials of “reach as fast as you can 
to grasp (or touch) the soda can.” The can will placed on a table at 80% of arm’s length at midline, 
a location affording maximum shoulder flexion and elbow extension.68 Table height will be adjusted 
for each individual and no trunk constraint or arm support will be provided during testing. Kinematic 
data will be recorded with a 10-camera PhaseSpace motion analysis system at a sampling 
frequency of 240 Hz. Data will be smoothed with a 4th order Savitky-Golay filter (acting on a 200 
ms window) and numerically differentiated to obtain marker velocities. A custom kinematic model 
consisting of 9 segments (pelvis, thorax, head, upper arm, forearm and hand) and with 54 degrees 
if freedom will be fitted to marker data using Matlab functions. Segment reference frames will be 
defined according to ISB guidelines.59 The velocity magnitude of a marker positioned above the 
base of the third metacarpal bone will be used to define start and end of the movement. Reach 
start will be defined as the instant when wrist velocity increases above 10% of its peak value, and 
reach end as the instant when it falls below the same threshold. Joint angles will be calculated 
through Euler decomposition following ISB guidelines. Shoulder flexion will be defined as the 
rotation around the z-axis between upper arm and thorax, and elbow flexion-extension as the 

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rotation around the z-axis between forearm and upper arm. Trunk displacement will be calculated 
as the displacement of a marker placed at T-10.  
 
• 
Microsoft Kinect based kinematic analysis: The Microsoft Kinect is a skeletal tracking sensor and 
therefore calculates the user’s body segments locations in 3-dimensional space (relative to the 
sensor). We have created a custom software program that translates Kinect body segment data 
into joint coordinates which then can be used to calculate kinematic variables. Analyzing motion 
with the Kinect will allow us to follow the day-by-day progression of each participant as he/she 
recovers arm movement. The procedure is as follows: at the beginning of each DDP or KTS 
intervention session, the program will guide participants through a standardized assessment of 
forward reach. We will calculate the shoulder and elbow joint angles from the recorded kinematic 
data by post processing it with custom Matlab software.  
 
• 
Secondary Outcome Measures:  
 
• 
The impact of the intervention on “real world” arm use will be assessed with the Stroke Impact 
Scale (SIS) Hand and Perceived Recovery subtests. The SIS-hand consists of 5-items regarding 
difficulty of paretic hand use during everyday tasks (i.e., picking up a dime, carrying a heavy object) 
during the previous two weeks. Items will be rated on a 5-point scale (5=not difficult, 1=cannot do) 
and reported as an average item rating, so scores approaching 5 represent less difficulty. The SIS-
recovery subtest is a single-item in which the participant rates his/her perceived post-stroke 
recovery from 0%-100% recovered.  
 
• 
Self-report scales such as the SIS could be limited by recall-bias, therefore accelerometry may 
provide a more accurate assessment of the intervention’s impact on real-world arm use.69-71 During 
the baseline training session subjects will be shown how to don small Actigraph triaxial 
accelerometers on the dorsal aspect of each wrist just proximal to the wrist joint.  Subjects will be 
instructed to don and wear the accelerometers for two days during the first week and two days 
during the final week of the program.  The accelerometers will be programmed to collect data at 
100 HZ summarized over 1 minute epochs. Raw data will be downloaded when the device is 
returned at the end of the study.  We will use these data to calculate a two Arm Activity Ratios 
(AAR) for each subject (first week, final week). This variable is calculated by creating a ratio of 
paretic to non-paretic accelerometer data (i.e., “activity counts”).72 The AAR is an often used UE 
accelerometer variable,69, 73 having a high correlation with an assessment of self-reported paretic 
arm use for daily activities71 which suggests that the AAR it is a valid method for assessing arm 
activity in the home environment. An AAR value of 1 indicates that both UEs were used equally as 
would occur during a bimanual task. A value >1 indicates greater use of the affected UE during the 
task.   
 
Study 3: Joint Range of Motion Validation 
• 
Microsoft Kinect based kinematic analysis: As described above (Aim 1) the Microsoft Kinect is a 
skeletal tracking sensor and therefore calculates the user’s body segments locations in 3-
dimensional space (relative to the sensor). We have created a custom software program that 
translates Kinect body segment data into joint coordinates which then can be used to calculate 
kinematic variables. Recently, we wrote new software codes to measure elbow and shoulder joint 
angles with the Kinect. We expect that these new codes are more accurate than the currently used 
codes. The purpose of this study is to investigate this expectation. 
 
• 
Laboratory based kinematic analysis: As described above (Aim 1) we will utilize our PhaseSpace 
Motion Capture (MoCap) system to collect arm motion data. Our MoCap system is considered the 
“gold standard” instrument with which to measure joint ranges of motion. MoCap data are analyzed 
with a state of the art biomechanical model according to industry standards. The Kinect measures 

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will be made concurrently and thus allow direct comparison in order to understand how similar 
(valid) Kinect-based measures are to MoCap measures.  
 
Study 4: E-learning for At-Home Paretic Arm Use 
 
• 
Feasibility will be assessed  
o Quantitatively by documenting the effect of the e-learning module on subjects’ arm motor 
ability, self-reported arm use at home, and self-efficacy as defined by the following 
standardized assessments administered before and after the 4 week learning module:   
 
Fugl-Meyer Upper Extremity Assessment (FMA-UE) as described above. 
 
Stroke Impact Scale (SIS) Hand and Perceived Recovery subtests as described 
above.  
 
The A Self-Efficacy Questionnaire as described above.  
 
A Stroke Knowledge Exam which will test the survivors’ understanding of stroke and 
stroke recovery. 
o In addition, we will document  
 
The primary problems (if any) that subjects report having with accessing the course. 
 
Subjects’ anecdotal comments/narrative made to study staff about their experiences 
using the course.  
o Qualitatively by informally analyzing the discussion board posts for themes that indicate the 
feasibility of the course (e.g., challenges subjects have with course access), subjects’ 
satisfaction with the course, and content that subjects say is meaningful.  
 
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
Inclusion Criteria  
(1) Inclusion Criteria for Study 1: DDP Intervention:   
(a) experienced unilateral hemispheric ischemic or hemorrhagic stroke at least 3 months but no 
more than 7 years prior 
(b) exhibit voluntarily shoulder flexion of the affected arm ≥30° with simultaneous elbow extension 
≥20°. We reason that persons at this motor ability level have residual arm activation and enough 
ability to engage in treatment-related reaching movements elicited by the computer games 
(c) baseline FMA-UE score of at least 19 points but no more than 52 points (out of 60 points) based 
on our previous published research in which we defined categories of post-stroke UE motor 
impairment 
(d) passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal 
values 
(e) 21-90 years of age 
(f) a caregiver or friend who is willing to assist with the set up and operation of the computer game 
throughout the 6 week intervention.   
 
(2) Inclusion Criteria for Study 2: Focus Groups: 
(a) Subjects with stroke who have played Duck Duck Punch at least 3 time 
(b) The caregiver of someone who has played Duck Duck Punch at least 3 times 
(c) A therapist (occupational or physical) who has utilized Duck Duck Punch in at least 3 treatment 
sessions. 
 
(3) Inclusion Criteria for Study 3: Joint Range of Motion Validation 
(a) Subjects with stroke will be included as per the inclusion criteria identified above (Aim 1) 
(b) Neurologically healthy individuals will be included if they are aged 21-90 (age matched to our 
stroke sample) and without any neurologic or orthopedic condition that would interfere with shoulder 
and elbow motion.  

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(4) Inclusion Criteria for Study 4: E-learning 
a. Completed the DDP intervention study  described above (Study 1). 
 
 
Exclusion Criteria 
(1) Exclusion Criteria for Study 1: DDP Intervention:   
a) lesion in brainstem or cerebellum because lesions in these locations my interfere with the 
visual-perceptual and cognitive skills needed for motor re-learning as is expected to occur as a 
result of the intervention 
b) presence of other neurological disease that may impair motor skills (e.g., Parkinson’s Disease) 
c) pain in the affected arm that interferes with reaching movements 
d) significant cognitive impairment, defined as Montreal Cognitive Assessment score < 22 
e) orthopedic condition or impaired corrected vision that alters the kinematics of reaching 
a) unable to travel to the UE Motor Function Laboratory in Charleston SC 4 times (pre-, mid- post- 
and retention testing).  
 
(2)  Exclusion criteria for Study 2: Focus groups: 
a) Non-English speaking.  
 
(3) Exclusion Criteria for Study 3: Joint Range of Motion Validation 
(a) Subjects with stroke will be excluded as per the exclusion criteria identified above (Aim 1) 
(b) Neurologically healthy individuals will be excluded if they have a neurologic or orthopedic 
condition that interferes with shoulder and elbow motion such as previous fracture, rotator cuff tear, 
stroke, spinal injury. 
 
• 
The study sample shall be inclusive of the general population of adults with stroke-related arm motor 
impairment in South Carolina with no restriction in regard to gender, race, age, and socioeconomic 
status.  There are no exclusion or inclusion criteria which would exclude or preclude women or 
minorities from participating in this study. Women and minorities will be included in the research as 
they volunteer.   
 
• 
No children will be included in this study; participants will be over 21 years of age. Children will not be 
included because childhood stroke requires a unique theoretical foundation guiding the design of 
rehabilitation therapy programs.  Childhood stroke rehabilitation is beyond the scope of this study. 
 
6.0 
Number of Subjects 
 
Study 1 DDP Intervention: Sample size was calculated based on FMA-UE data obtained from our 
previous work and the preliminary study described above35, 37, 40 which, when the datasets were 
pooled, yielded a common standard deviation of 8 points. The study was powered to detect an 8-
point difference in the pre- to post-training FMA-UE scores, a clinically meaningful change.74  When 
comparing the two extreme groups (mild and moderate-severe impairment) with a Wilcoxon Mann 
Whitney test at a 5% significance level, a sample size of 20 individuals in each strata, for a total 
N=60, will yield 80% power to detect a minimum effect size of 1.00. Anticipating a 10% drop out 
rate evident in rehabilitation studies similar in duration/intensity to ours we will inflate the sample 
size to N=66. 
 
Study 2 Focus Groups: Using Morse’s guidelines,75 8 subjects per focus group will provide 
adequate data to reach saturation. Thus we will enroll a sample of n=64 subjects for focus groups. 

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Rationale: Therapists and stroke survivors/caregivers represent distinct consumer groups. Each 
consumer group will provide different types of feedback based on their needs. Therefore, we will 
have 8 focus groups; 4 comprised of therapists from different practice settings and 4 
comprised of survivors and caregivers. To assure an equal representation from each consumer 
group we will enroll n=16 individuals with stroke, n=16 caregivers of individuals with stroke and 
n=32 stroke rehabilitation therapists to assure 8 subjects per focus group.  
 
Study 3 Joint Angle Validation: 10 subjects with stroke and 10 neurologically healthy individuals 
will be enrolled.  
 
Study 4: E-learning for At-Home Paretic Arm Use: This is a proof of concept study to ascertain 
the feasibility of stroke survivors ability to access and benefit of a newly developed Moodle e-
learning module.  Thus n=3 subjects will be included.  
 
7.0 
Setting 
Study 1 DDP Intervention:   
• 
Research Laboratory: All outcome evaluations will be administered in the MUSC College of 
Health Professions Upper Extremity Function research laboratory.  
• 
Subjects’ Homes: Subjects will be provided with a laptop, Kinect, and/or X-box (depending on 
randomization) to take home. Subjects will play the computer games in their home 
environment. Dr. Woodbury’s research team will phone each subject once per week. If a 
subject has a problem with the computer or software that cannot be resolved via phone, Dr. 
Woodbury or a member of her research team will visit the subject’s home to fix it. 
Study 2 Focus Groups:  There will be a total of 8 focus groups.   
• 
4 will occur in the MUSC College of Health Professions Upper Extremity Function research 
laboratory,  
• 
4 will occur at Recovr headquarters in Clemson SC.  Dr. Woodbury and her research team will 
oversee all focus groups.  
Study 3 Joint Angle Validation 
• 
Research Laboratory: The motion capture evaluation (Kinect and PhaseSpace) will be 
conducted in the MUSC College of Health Professions Upper Extremity Function research 
laboratory.  
 
Study 4 E-learning 
• 
Research Laboratory: The initial e-learning orientation and training session will occur in 
the MUSC College of Health Professions Upper Extremity Function research laboratory. In 
addition, all standardized assessments will be administered before and after the 4 week 
module in this laboratory.  
• 
Subjects’ Homes: Subjects will either use their personal device (phone, tablet or laptop) to 
access the e-learning Moodle course, or will use a laptop from the research laboratory (the 
same laptop used to play the DDP game) to access the Moodle course. Subjects will 
access the e-learning course from home.  
 
 

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8.0 
Recruitment Methods 
 
Study 1: DDP Intervention 
 
Participants with stroke will be recruited from three sources: 
 
• 
The Center for Rehabilitation Research in Neurological Conditions (CRRNC) stroke research 
recruitment database (approved MUSC IRB #15991) which currently contains ~250 persons with 
stroke who have signed informed consent and agreed to be contacted for research participation. 
Center affiliated investigators (such as the PI) can recruit subjects from this database.  
 
• 
The COBRE Stroke Recovery Research Center (SRRC) stroke research recruitment registry called 
RESTORE (approved MUSC IRB #37803). The Registry currently contains the contact information 
for ~200 individuals with stroke who have provided consent to be contacted for potential 
participation in research studies. Importantly, the Center supports a dedicated project coordinator 
who enrolls 5-10 new participants into the registry per month and also supports information 
technology resources needed to maintain/update the Registry’s infrastructure as needed.  
 
• 
The South Carolina Young Stroke Survivors Support Group is supported in part by the MUSC 
College of Health Professions Department of Health Science and Research (the PI’s home 
department) and the Roper-St. Francis Healthcare Network. It is a group of stroke survivors, 
caregivers and healthcare providers (therapists, nurses and research scientists) who provide 
emotional support, resource and educational support to persons whom have sustained a stroke at 
a young age.  Approximately 30 survivors and their family/caregivers attend monthly in-person 
meetings in Charleston SC.  Approximately 150 survivors are members of the group via Facebook. 
Information about the current study will be provided to this group for study recruitment.  
 
• 
Flyers in stroke rehabilitation facilities and written advertisements in stroke recovery newsletters 
(e.g., Most stroke support groups have a newsletter). 
 
Study 2: Focus Groups 
 
Focus group participants will be recruited in the following ways: 
 
• 
Individuals with stroke who participated in Study 1 (DDP intervention) will be offered opportunity to 
participate in the focus groups via a written recruitment letter.  
• 
Caregivers of the individuals with stroke who participated in Study 1 (DDP intervention) will be 
offered opportunity to participate in the focus groups via a written recruitment letter. 
• 
DDP is currently being used in several stroke rehabilitation facilities across South Carolina.  A letter 
(to be developed once this project begins and will be approved in a future amendment to this 
project) will be sent to each of these facilities inviting their therapists to participate in the focus 
groups.  
 
Study 3 Joint Angle Validation (a single evaluation visit of ~1 hour) 
• 
Individuals with stroke who participated in Study 1 (DDP intervention) will be offered opportunity to 
participate in this study after their final parent study evaluation session.  
• 
Caregivers of the individuals with stroke who participated in Study 1 (DDP intervention) will be 
offered opportunity to participate in this study.  The project team will give caregivers information 
about this study during conversations with caregivers who typically accompany survivors to testing 
sessions in our research laboratory. In the past, we have found that caregivers are eager to 
participate in simple cross sectional evaluation sessions like this. A recent caregiver stated “I like 

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to do these evaluations too, it is exciting to be a part of things rather than just sit here and wait for 
(survivor’s name) to finish!” 
• 
Colleagues of the research team will be provided with broad information about this study during 
informal conversations and email correspondence.  If a colleague expresses interest in 
participating, more detailed information will be provided verbally and/or in email.  
• 
If the colleague would like to be considered for the study, he/she will schedule an in-person 
appointment with the PI or study therapist at the research laboratory. The potential participant will 
be read the inclusion/exclusion criteria for healthy participants (specified above).  If he/she agrees 
that he/she meets those criteria, then informed consent will proceed as described below.  
 
Study 4 E-learning 
Three (n=3) participants who have completed the DDP intervention study described above (Study 1 
above) will be recruited.  Study team members will verbally inform subjects of the e-learning study 
during the final DDP intervention study visit.  
 
 
9.0 
Consent Process 
Study 1: DDP Intervention 
• 
Once a potential subject expresses interest in study participation, he/she will schedule an appointment 
to meet with the research team in the CHP upper extremity motor function research laboratory at a 
convenient time for the stroke survivor/caregiver’s schedule.  At that appointment, Dr. Woodbury (the 
PI) or an approved member of her research team will meet with the potential subject in a quiet, private 
room in the CHP Research Building. Several such rooms have been designated in this building for 
informed consent purposes. Dr. Woodbury or the research team member will read the informed consent 
form to the potential participant and his/her caregiver. To assure that the potential participant 
understands the study procedures, specifically the requirement for regular self-directed interaction with 
the computer game at home, Dr. Woodbury or the research team member will carefully explain these 
procedures and watch the potential participant and caregiver for signs of non-comprehension. The 
researcher will pause frequently to ask if there are any questions, and will answer those questions 
promptly. If needed, the potential subject and his/her caregiver will be shown a demonstration of the 
computer game (a demonstration console is located in Dr. Woodbury’s research laboratory). The 
potential subject will be told that he/she can take as much time as needed to decide on study 
participation. If he/she seems unsure or hesitant, he/she will be encouraged to take the form home to 
re-read and call back with any questions. When ready, the subject will sign the informed consent form. 
It is possible that the stroke-related arm paresis may occur on his/her dominant hand which will make 
it impossible to use the dominant hand to sign the form. In that case, the subject will be encouraged to 
sign the form with his/her non-dominant hand. 
 
Study 2: Focus Groups 
• 
4 focus groups will be held at MUSC. Once a potential subject expresses interest in study participation, 
he/she will schedule an appointment to meet with the research team in the CHP upper extremity motor 
function research laboratory at a convenient time for the potential participant’s schedule.  At that 
appointment, Dr. Woodbury (the PI) or an approved member of her research team will meet with the 
potential subject in a quiet, private room in the CHP Research Building. Several such rooms have been 
designated in this building for informed consent purposes. Dr. Woodbury or the research team member 
will read the informed consent form to the potential participant. Dr. Woodbury or the research team 
member will carefully explain the focus group procedures and watch the potential participant for signs 
of non-comprehension. The researcher will pause frequently to ask if there are any questions, and will 
answer those questions promptly. The potential subject will be told that he/she can take as much time 

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as needed to decide on study participation. If he/she seems unsure or hesitant, he/she will be 
encouraged to take the form home to re-read and call back with any questions. When ready, the subject 
will sign the informed consent form. It is possible that the stroke-related arm paresis may occur on 
his/her dominant hand which will make it impossible to use the dominant hand to sign the form. In that 
case, the subject will be encouraged to sign the form with his/her non-dominant hand. 
• 
4 focus groups will be held at Recovr headquarters in Clemson SC. The consent process for these 
participants will follow the same procedure as described in the previous paragraph, except that consent 
will be obtained at Recovr headquarters in Clemson SC rather than at MUSC. There are several small, 
quiet offices at Recovr which will be designated for informed consent.  
Study 3 Joint Angle Validation 
• 
The consent process for the subjects with stroke and neurologically healthy individuals will be the 
same as described above for Study 1.  Note: this study will utilize its own informed consent because 
of the small sample size needed and that we do not expect all subjects enrolled in the parent study 
to participate in this smaller study.  
• 
No children will be enrolled in this study, therefore there are no procedures for obtaining parental 
consent.  
• 
No cognitively impaired adults will be enrolled in this study. As per the exclusion criteria, subjects’ will 
be excluded if the Montreal Cognitive Assessment score <22 points. 
 
Study 4: E-learning for At-Home Paretic Arm Use 
• 
Once a subject completed the DDP intervention study described above (study 1), he/she will be 
told about this e-learning study by the study team. If he/she expresses interest, an initial session 
will be scheduled to obtain informed consent. The consent process will the same as per the 
procedures described above.  
 
10.0 
Study Design / Methods 
 
Study 1: DDP Intervention 
• 
Study Design: This is a prospective single-blind randomized trial with parallel arm design. N=66 
individuals with post-stroke UE hemiparesis will be enrolled; 20 participants each per 3 UE impairment 
levels (mild, moderate, moderately-severe) as defined by the Fugl-Meyer Upper Extremity Assessment 
(FMA-UE) categories described in our previous publication.36 A block randomization procedure will 
assure equal group size by assigning each patient to an impairment level based on the baseline FMA-
UE. Within each stratum, a simple randomization procedure will be used to assign to treatment group 
(DDP vs. commercially available Kinect game).  
 
• 
Research Procedures: All procedures described here are research procedures. There are no non-
research procedures that will occur during study visits. All visits will be only for research purposes.   
 
• 
Procedure: Subjects will travel to Dr. Woodbury’s MUSC research laboratory 4 times for evaluation; 
pre-, mid-, post-treatment and 30 days post-treatment to test retention.   
 
• 
Randomization to Treatment Groups: At the pre-treatment visit, after signing informed consent, the 
Fugl-Meyer Upper Extremity Assessment will be administered (see description below). Its summed 
score will be the basis for assignment to an impairment strata. Subjects within each stratum will be 
randomized to play DDP or a commercially available Kinect game, the Kinect Target Shoot.  Both 
computer game interventions are described above in the section titled 3.0 Intervention to be Studied.  

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• 
To assure retention of enrolled subjects: During our preliminary study, we experienced unexpected 
post-randomization subject drop out. Each subject who dropped out reported that upon learning that 
he/she had not been randomized to the DDP group, he/she was no longer motivated to continue the 
study because he/she had hoped to play DDP. Therefore, for this proposed study we will offer DDP 
to all subjects enrolled in the Kinect Target Shoot group. We will not change the design of this 
prosed study, but instead offer the opportunity to play DDP for an additional 6 weeks after conclusion 
of the study, (i.e., after they have completed the 30 day retention testing) as a proactive way to address 
potential subject drop out. Data obtained from this additional DDP game-play will provide additional 
data for estimating effect sizes.  
 
 
• 
Orientation to the computer game: At the pre-treatment visit, subjects will receive 30-60 minutes of 
training and for their assigned computer game, an instruction manual, laptop, and Kinect. Subjects in 
the Target Shooting group will also receive an X-box as is required for this game (but not for DDP). 
The study therapist will review the manual, demonstrate game set-up and play and provide instructions 
regarding study procedures. With therapist supervision, subjects will play the game while the caregiver 
operates the computer and provides coaching. Subjects will take the equipment home. The therapist 
will call the subject to verify successful at-home installation, and if needed, the therapist will travel to 
the subject’s home to assist with in-home set up and provide further instruction. No further home visits 
will be provided unless the subject/caregiver encounters equipment or software problems that cannot 
be resolved via phone or email contact with study staff. Subjects will return the equipment at the final 
assessment session. 
 
• 
Weekly Phone Calls: The therapist will phone each subject (both groups) weekly. During this phone 
call, the therapist will remind subjects of the importance of their participation in the activity, provide 
assistance with adjusting the game difficulty (see above), to document pain or fatigue (see below) and 
also will address concerns, questions, or technical difficulties.  
 
• 
Dose: Dose will be matched across groups. All subjects will engage in 18 days (3 days per week over 
6 weeks) of DDP or the commercially available game. All subjects will be instructed to play the game 
Schedule of Events 
 
Pre-
intervention 
visit 
 
Intervention 
Mid-
intervention 
visit 
Intervention 
Immediately 
post-
intervention 
visit 
30 day 
follow up 
retention 
visit 
 
For non-DDP 
players who cross 
over to DDP, 
immediately post-
DDP intervention 
visit 
Informed Consent 
X 
Either KTS 
or DDP for 9 
sessions; 60 
minutes per 
day, 3 days 
per week 
over 3 
weeks 
 
Weekly 
phone calls 
from study 
therapist to 
participant 
 
Either KTS 
or DDP for 9 
sessions; 60 
minutes per 
day, 3 days 
per week 
over 3 
weeks 
 
 
Weekly 
phone calls 
from study 
therapist to 
participant 
 
 
Non-DDP 
players will 
cross over 
and play DDP 
for 6 weeks 
(see section 
10.0 of 
protocol for 
description) 
 
Weekly phone 
calls from 
study 
therapist to 
participant 
 
Screening 
Patient-reported: 
• 
stroke type 
• 
demographics 
• 
pain  
• 
orthopedic 
condition(s) 
X 
 
 
 
 
Montreal Cognitive 
Assessment 
X 
 
 
 
 
Orientation to 
computer game 
X 
 
 
 
 
Fugl Meyer 
Assessment of the 
Upper Extremity 
X 
X 
X 
X 
X 
Wolf Motor Test 
X 
X 
X 
X 
X 
Kinematic Analysis 
X 
X 
X 
X 
X 
Stroke Impact Scale 
X 
X 
X 
X 
X 
Accelerometry 
X 
X 
X 
X 
X 

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for 60 minutes/day. It is likely that some subjects will choose to distribute this dose throughout a day. 
To assure matching does, custom software will be loaded onto the laptop that displays and records the 
duration of game play as it accumulates over a 24-hour period. Subjects will be instructed to “play the 
game until the timer shows that you have been playing for 60 minutes in a day.”  
 
• 
Rationale for the Dose: We chose this dose because it is similar to post-stroke arm rehabilitation 
programs having distributed practice schedules. For example, modified constraint therapy consists of 
15 total hours of treatment; 30-minute sessions, 3 days/week for 10 weeks.65 Similarly, UE functional 
task training consists of 18 total hours of treatment; 1 hour sessions, 3 days/week for 6 weeks.66 and 
impairment oriented training consists of 20 total hours of treatment; 1 hour sessions, 5 days/week for 
4 weeks.67 Because some participants may not be able/ may not choose to complete 60 minutes each 
day, the intensity of training (averaged amount of time per day) will be added as a covariate to the 
primary analysis. 
 
• 
Possible Fatigue and/or pain: The treatment program may induce fatigue and/or pain. Possible 
fatigue/pain is addressed in the following ways:  
 
• 
(1) Subjects will self-direct completion of the Borg Rating of Perceived Exertion (RPE)76 
each day. The RPE and instructions will be incorporated into the study’s instruction manual 
which will be provided to subjects during the 1st baseline visit. Ratings of 12-14 on the Borg 
scale suggest that the activity requires moderate exertion. Because subjects will self-direct 
their own treatment we expect that they will self-monitor and take breaks as needed and 
therefore we do not expect ratings to reach or exceed this level. However, we will provide 
clear instructions that if an RPE rating is above 14, the subject should rest and contact the 
study therapist.  
• 
(2) The study therapist will phone each participant weekly to inquire about and document 
client self-reported pain, especially pain in the paretic shoulder on a 0-10 ordinal pain 
scale.77 If a client reports pain ≥5 (moderate), he/she will be instructed to cease the study 
intervention for the day. If the subject reports that pain has been moderate or severe (≥5) 
for several consecutive days, the subject will be counseled to stop the study and to contact 
his/her physician.  
 
Study 2: Focus Groups 
 
Aim 3: Determine the treatment validity of the DDP report as a measure of impairment and response 
 
• 
Rationale: A review of the literature and therapy practice guidelines did not provide a template to guide 
a clinically useful performance report, thus motivating this aim. The purpose is to answer two questions: 
what information about the session does a therapist need, and what information does the 
patient/caregiver need?  From a therapists’ perspective, useful output will guide documentation and/or 
treatment planning. From a survivors’ perspective, useful output will increase knowledge of their own 
impairments to empower future interactions with the medical team (e.g., ask informed questions, co-
plan subsequent treatments). Informal feedback from therapists, patients and caregivers that we have 
received on the current report suggests a need to optimize this report.  
 
• 
Focus Groups: To develop an informative DDP performance report we will elicit the perspectives and 
opinions of the consumer group by78 conducting 8 focus groups; 4 each at the (1) Medical University 
of South Carolina, Charleston, SC and (2) Recovr headquarters in the Greenville SC area. Each group 
will last ~2 hrs.  
 
• 
Procedure: During the first 30 minutes, we will provide participants with an overview of DDP 
background/development.  During the subsequent 90 minutes, we will show de-identified 
videos of stroke patients playing DDP. The Focus Group leader (Dr. Woodbury) will guide 

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a discussion about (1) what elements of the player’s performance would a clinician select 
as most relevant for documenting patient status/progress in his/her practice setting, and (2) 
what elements would a patient/caregiver select as most informative to him/her.   
• 
The group discussion will be guided with a Focus Group Guide79 to address the core 
elements of the performance report’s utility,80 i.e., ease of interpretability, format, meaning 
to the therapist, meaning to the patient/caregiver). Dr. Jillian Harvey, who is an experienced 
qualitative researcher, will oversee development of the Focus Group Guide.  
• 
Audio recording: The focus group will be audio recorded. The rationale for audio recordings 
is to develop a transcript of the discussion that will be used to establish critical discussion 
themes. These themes will then guide the design of the performance report’s elements. 
Woodbury will lead the groups and a designated project member will monitor an audio 
recorder. Immediately after each session, we will upload the digital files into a dedicated 
secure file on the MUSC network. Audio files will be transcribed by a professional 
transcription service. 
• 
Field Notes: A project member will take detailed Field Notes to record the sequence of 
speakers, notable consumer reactions (facial expressions, etc.) and any other non-verbal 
activities.  
 
Study 3 Joint Angle Validation (a single evaluation visit of ~1 hour) 
Aim: To validate a new method of measuring shoulder and elbow range of motion.  
• 
Rationale: We have written new software codes to analyze Microsoft Kinect arm motion tracking. 
We anticipate that the new calculations of joint ranges of motion are more accurate than our 
previous measurements, but have no evidence to support this hypothesis.  
• 
Study Design: A single cross sectional evaluation session that will be ~1 hour duration. 
• 
Procedure:  10 neurologically healthy individuals and 10 individuals with stroke will attend a single 
evaluation session in our motion capture laboratory. Each subject will be seated on a backless stool 
in a standardized starting position. Subjects will be instructed to “reach as fast as you can” to touch 
virtual targets on a computer screen. The subject will view an arm avatar on the computer screen 
which is controlled by a Kinect motion sensor (as in the Duck Duck Punch computer game 
described above). Subjects will reach to hit the virtual targets by moving his/her physical arm. The 
targets will be positioned at a location of ~80% of arm’s length and located in each of 9 locations: 
at, below and above the horizon at midline and at 30 degree angles to the right and left of midline. 
The purpose of this 9 target grid is to measure shoulder and elbow angles throughout the reaching 
workspace in order to understand how our joint angle calculations with the Kinect may be affected 
by arm configuration relative to the Kinect sensor. Moreover, all of these target locations will afford 
maximum shoulder flexion and elbow extension68 and thus elicit maximum and minimum joint angle 
measures. The Microsoft Kinect will record arm location at the same time that kinematic data are 
recorded with a 10-camera PhaseSpace motion analysis system. The PhaseSpace data will be 
analyzed as described in the Aim 1 procedures above. The Kinect joint angles will be calculated 
using our new computer software codes, then Kinect measurements will be compared to the same 
joint angle measurements made with the  PhaseSpace system.  
• 
Data Analysis: The concurrent validity of the Kinect-based measures compared to the 
PhaseSpace measures will be assessed with an Intra Class Correlation Coefficient (ICC). 
Acceptable measures will be defined as similar within a 10 degree measurement error. 
 
Study 4: E-learning for At-Home Paretic Arm Use 
 
Aim 4: Test the feasibility of an e-learning module to elicit patient self-directed paretic arm use in 
their home 
 
Rationale: Results from recently concluded large stroke rehabilitation clinical trials clearly indicate a 
disparity between paretic arm use during (1) therapy vs. (2)  at home or in the community. That is, patients 

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safely accomplish hundreds of paretic arm movement repetitions during a structured therapy session. Yet, 
they fail to translate motor skills from clinic to home. As documented by wrist-worn activity monitors, 
patients rarely move the paretic arm during non-structured (non therapist initiated) real-world 
home/community activities. Reasons for this disparity include patients’ self-reported lack of knowledge 
regarding optimal ways to care for him/herself after therapy has ended. It is likely that the current therapy 
model of in-clinic therapist-guided arm movement practice inhibits patients’ development of self-
management skills by reinforcing reliance on the therapist’s guidance for arm use which renders patients’ 
unskilled in self-directed skill implementation.  In efforts to address this problem, we created an online 
learning module within MUSC’s Moodle e-learning platform for stroke survivors designed to bridge the gap 
between the clinic and home. The purposes of this e-learning module are to (1) provide information about 
stroke motor recovery to elicit cognitive learning for self-management and (2) coach stroke survivors during 
at-home paretic arm use via therapist-patient teleconferences to elicit psychomotor learning for self-
management.  
 
Study Design: This is a proof of concept study to ascertain the feasibility of stroke survivors ability to 
access and benefit from the Moodle e-learning module.  
 
Subjects: Three (3) stroke survivors who have completed the DDP study described above will be recruited 
to test the e-learning module.   
 
Procedure: After obtaining informed consent, the 3 subjects will begin the study together as a group.  
• 
Subjects will attend an in-person e-learning orientation/training session. The learning module’s 
purpose and objectives will be reviewed. Subjects will be shown how to access the e-learning 
module (e.g., sign on, click through the course menu, access a lesson, contribute to a discussion, 
sign into a tele-conference), and then practice these tasks under the in-person supervision of study 
staff who can answer questions and provide extra training as needed. The e-learning module is 
offered on Moodle, the MUSC e-learning platform. Subjects will use their own device (laptop, tablet 
or phone) for the course. However, if they do not have a device, a laboratory laptop computer 
(dedicated for laboratory research studies with its configuration already approved by MUSC OCIO 
and CHP IT) will be made available for participants to take home for the duration of the study. 
MUSC students and faculty easily and routinely access Moodle learning modules from personal 
devices, thus we do not expect that participants will have difficulty accessing the course once they 
become familiar with the environment.  
• 
After this training session, subjects will be tested for paretic arm motor ability (Fugl-Meyer Upper 
Extremity Assessment), self-reported difficulties with at-home arm use (Stroke Impact Scale), and 
self-efficacy with home arm use (Self Efficacy Scale).  
• 
Subjects will then participate in the course for 4 weeks at home. Each week the course will offer 
(1) a lesson such as a video, reading, or Panopto-recorded lecture from a research team member 
(or other stroke rehabilitation expert), (2) an asynchronous discussion about the lesson via the 
course Discussion Board, and (3) a video teleconference meeting between the 3 subjects and the 
study’s occupational therapist. The overall idea is that the lesson will address reasons why at-home 
paretic arm use is important (e.g., to facilitate long term neural plasticity), facilitate the subjects to 
set arm use goals for themselves, receive tips/pointers from the therapist for implementing home 
arm use, and engage in peer support with other survivors who are also seeking to use their paretic 
arm more.  
• 
At the end of the 4 week course, subjects will return to MUSC for a final testing session where the 
measures of paretic arm movement ability, self-reported at home arm use, and self efficacy will be 
re-administered.  
 
 
11.0 
Specimen Collection and Banking  
• 
No specimens will be collected or banked. 

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12.0 
Data Management  
 
Study 1: DDP Intervention 
• 
Sample size was calculated based on FMA-UE data obtained from our previous work and the 
preliminary study described above35, 37, 40 which, when the datasets were pooled, yielded a common 
standard deviation of 8 points. The study was powered to detect an 8-point difference in the pre- to 
post-training FMA-UE scores, a clinically meaningful change.74  When comparing the two extreme 
groups (mild and moderate-severe impairment) with a Wilcoxon Mann Whitney test at a 5% 
significance level, a sample size of 20 individuals in each strata, for a total N=60, will yield 80% 
power to detect a minimum effect size of 1.00. Anticipating a 10% drop out rate evident in 
rehabilitation studies similar in duration/intensity to ours we will inflate the sample size to N=66. 
• 
Hypothesis: We hypothesize that DDP will improve arm motor skills more than the commercially 
available game. The rationale for this hypothesis is that the difficulty of DDP game play can be 
adjusted according to the patient’s level of ability in order to elicit arm movement practice at the 
“just-right” level of difficulty, neither too difficult nor too easy, to maximize post-stroke motor skill 
relearning and skill reacquisition.  
• 
Missing Data: Since each patient will be observed over a 3-month period, it is possible that the 
patient will miss a visit and/or drop out. If a patient misses a testing session we will make all 
attempts to reschedule. If the patient drops out an intent-to-treat analysis will be applied and the 
missing data will be treated as missing at random (MAR). If missing occurs, multiple imputation 
methods will be used for data analysis (PROC MI and PROC MIANALYZE, in SAS version 9.3). 
The biostatisticians will oversee this process.  
• 
Dependent Variables: Five dependent variables will measure arm motor skills; (1) reduction of arm 
motor impairment as measured by the FMA-UE, (2) improved arm motor function as measured by 
the WMFT, (3) improved voluntary shoulder and (4) elbow ranges of motion, and (5) reduced trunk 
(T-10) movement compensation as measured by kinematic analyses.  
• 
Independent Variables: The independent variables are Treatment and Time. The between subjects 
factor “Treatment” has 2 levels (DDP vs. Kinect Target Shoot) with 3 impairment levels nested 
within each level (mild, moderate, severe). The within subjects factor “Time” has 4 levels; Pre, Mid, 
Post and Retention.   
• 
Data Analysis of Primary Outcome Variables:  
o Two, two-way mixed model ANOVAs will be used to assess the main effects of Treatment 
on the primary outcome measures (FMA-UE, WMFT and kinematic variables). The intensity 
of training (averaged number of minutes of game play per day) will be a covariate. 
Significance for all comparisons will be alpha = 0.05.  
o Segmented Regression Modeling: For each DDP subject, we will estimate specific 
thresholds that mark the number of movement repetitions associated with a change in the 
Interjoint Coordination (IJC) treatment response using segmented regression analyses. To 
understand the relevance of this analysis, consider the pilot data presented in Figure 8 
above. As shown, this subject seemed to have a negative treatment response in the first 
week of the DDP program. That is, she exhibited more elbow flexion than elbow extension 
when reaching forward to hit DDP targets as evidenced by a downward slope in the curve. 
Then, on day 5 she exhibited dramatic gains in elbow extension as evidenced by the upward 
slope of the curve. The shift from a downward to an upward slope is marked by the day 5 
data point which is like a joint between the segments of the curve. The segmented 
regression model will capture this phenomenon. In this analysis we will essentially fit two 
linear (or polynomial) regression models that meet at a common value called the joint-point 
(threshold). The threshold will be defined as the number of movement repetitions at which 
this joint-point occurs. In addition, we will calculate the average rate at which each individual 
improves elbow extension (slope of the line) after reaching the threshold.   

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o Growth mixture modeling (GMM): We will follow the segmented regression modeling with 
GMM, which offers a robust statistical procedure to “uncover” heterogeneous treatment 
response patterns. While conventional statistical modeling assumes a single mean value 
and variance, GMM allows several mean values around which subgroups vary thereby 
showing how different people recover in different ways. The GMM will calculate “growth 
classes” of subject groups who show similar patterns of change in IJC. Our a-priori 
hypothesis that subjects in each impairment strata (mild, moderate, moderate-severe) will 
show distinct patterns of recovery, i.e., we expect 3 classes of recovery. We will test whether 
there is one overall pattern of recovery that describes the entire sample (1-class), whether 
there are two patterns of recovery within the sample (2-classes) or whether there are three 
patterns of recovery in the sample (3-classes). The models are not nested (a 1-class model 
is not a subset of the 2-class model) because different individuals will make up each class 
and so we will define the best fitting model as the one having the lowest Bayesian 
Information Criteria (BIC) and an entropy value closest to 1.0.   
o Relating Dose to Response: After separating the sample into classes, we will average the 
threshold movement repetition values for each class (identified in the segmented analysis) 
and calculate a 95% confidence interval for of repetition values for each class. In addition, 
we will calculate the average rate at which each class improves IJC (slope of the line) after 
reaching the threshold.  This will allow us to determine the relationship between dose and 
response for each group.  
• 
Data Analysis of Secondary Outcome Variables: We will utilize ANOVAs to test the effect of 
Treatment on the average SIS-hand item rating and the average SIS-recovery scores. In addition, 
we will analyze the accelerometry data using a within-group repeated measures analysis to 
compare subjects’ first week AAR to final week AAR in order to determine if the treatment program 
elicited gains in subjects’ use of the paretic arm relative to the non-paretic arm. The secondary 
outcome data have an important purpose. At the conclusion of this study we anticipate a 
subsequent Phase III SBIR proposal of a larger, multi-site RCT that will enable clear decisions 
regarding the clinical utility and commercialization of DDP to therapists and stroke survivors. Our 
plan is to power that study on a measure of “real-world” paretic arm use. We reason that successful 
commercialization of DDP requires a clear understanding of how DDP elicits a motor recovery 
process that enables stroke survivors to integrate his/her paretic arm within the context of a 
meaningful daily activities. Therefore, obtaining SIS and accelerometry data in the present study 
will inform our decisions about which tool is the best measure of real-world use, and also inform 
future sample size calculations.  
 
Study 2: Focus Groups 
 
• 
Sample Size: Using Morse’s guidelines,75 8 subjects per focus group will provide adequate data to 
reach saturation. Thus we will enroll a sample of n=64 subjects for focus groups. Rationale: 
Therapists and stroke survivors/caregivers represent distinct consumer groups. Each consumer 
group will provide different types of feedback based on their needs. Therefore, we will have 8 focus 
groups; 4 comprised of therapists from different practice settings and 4 comprised of 
survivors and caregivers. To assure an equal representation from each consumer group we will 
enroll n=16 individuals with stroke, n=16 caregivers of individuals with stroke and n=32 stroke 
rehabilitation therapists to assure 8 subjects per focus group.  
• 
Coding of Data: Once checked, the transcripts will be imported into QSR International's NVIVO 8 
software for coding. The coding process involves reviewing text, line by line, to identify embedded 
concepts in order to develop a coding framework hierarchy. Drs. Harvey and Woodbury will be 
responsible for coding. They will develop the initial coding framework then meet with the research 
team to review and discuss. The team will recommend revisions as necessary.  
• 
Analysis: Data will be analyzed using the constant, comparative method commonly used in 
qualitative analysis.82 All data will be subject to the coding framework; if an existing code is found 
to be representative, it will be coded accordingly. If existing codes are not representative, a new 

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Page 26 of 32 
 
code will be added, and then the data recoded. As data are coded, the investigators will review the 
text related to individual codes to define patterns among themes. We will use the themes to identify 
aspects of treatment validity that can provide the basis for modifications of the performance report, 
review potential modifications, and finalize the reports.  
• 
Efforts to ensure the trustworthiness of data: We will follow guidelines for ensuring the 
trustworthiness and quality of conclusions drawn from qualitative data.83 Definitions of codes, 
revisions to the coding framework, and project member debriefings will provide continuing 
documentation to ensure that project findings are objective and can be replicated.  
• 
Multiple Iterations: We will obtain consensus on the report’s content and design using a Delphi 
method because it gauges usefulness of opinions based on repeated feedback.84 Procedure: 
Working at each step with a graphic designer (who will be employed by the company Recovr), we 
will conduct the Delphi via a website for participant convenience (the same participants as for the 
focus groups). The prototype report, as initially designed based on focus group feedback, will be 
posted at an MUSC supported (secure) site. Participants will be asked to rate their endorsement of 
each section on a 4-point scale (strongly dislike, dislike, endorse, strongly endorse) and provide a 
brief rationale. Using Green’s criterion, sections that obtain a rating of 3 (endorse) or higher by 70% 
of the participants or a median of ≥3.25 will be retained from the 1st round and not presented in the 
next round.86 Sections that do not reach this criterion will be re-designed based on comments 
provided, and re-presented to panelists in the next round. Our goal is to meet consensus on all 
sections.  If we cannot meet consensus, we end the rounds once panelists report an average of 
<15% change in their responses over the repeated rounds87 and select the sections with the highest 
median ratings.   
• 
The information from the focus groups + Delphi method will then be incorporated into a finalized 
report and incorporated into DDP. 
 
Study 4: E-learning for At-Home Paretic Arm Use 
• 
Study Data: This is a proof of concept feasibility study. Prior to, and immediately following the 4 
week e-learning course, data will be collected to document subjects’ (1) paretic arm movement 
ability via the Fugl Meyer Upper Extremity Assessment; (2) self-reported difficulties using the 
paretic arm via the Stroke Impact Scale; and (3) self efficacy via the Self Efficacy Scale. In addition, 
subjects’ comments on the feasibility of accessing the course will be documented.  
• 
Analysis: No statistical analysis will be done. Instead, only descriptive data will be presented so as 
to provide an indication of the feasibility of an e-learning module to elicit self management skills. 
These data will provide pilot data for a future, properly powered clinical trial of the e-learning self-
management course.  
 
 
Describe the steps that will be taken to secure the data to maintain confidentiality 
• 
The above data will be collected by study staff all of whom will have documentation of human 
subjects training.  
 
• 
All data will be de-identified prior to storage on the MUSC network. That is, PHI will separated from 
the data prior to its storing. After signing informed consent, subjects will be assigned a study specific 
identification code that will not contain PHI. This de-identified code will be used to identify the 
participant throughout the study.  
 
• 
There will be one hard-copy file that will link the study code to the participant’s name.  The only 
people having access to this file will be the PI and study coordinator.  The hard-copy file will be 
stored in a locked cabinet in the study coordinator’s office. 
 

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• 
All electronic records will be stored in password protected files on the MUSC network with the 
highest level of security available at the time. 
 
• 
Identifiable data will not leave MUSC, documents with identifiers (e.g., ICF, enrollment log) will be 
kept at MUSC and stored in a locked cabinet in the study coordinator’s office.  Only de-identified 
data will be shared with Recovr for the purposes of scientific presentations, manuscripts, and 
continued commercialization of DDP.  
13.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects  
• 
What will be monitored: Study subjects will be monitored for fatigue and pain. 
• 
How frequently: Subjects will be monitored weekly during phone calls from the study therapist to 
the participant. As per procedures described above, each subject will keep a record of fatigue using 
the Borg Rating of Perceived Exertion scale in his/her study manual. He/she will be instructed to 
record this value daily throughout the study. The study therapist will phone each participant weekly 
to inquire about and document these fatigue ratings. In addition the study therapist will document 
client self-reported pain on a 0-10 ordinal pain scale. Recommendations will be made based on the 
input received.   
• 
Ratings of 12-14 on the Borg scale suggest that the activity requires moderate exertion. Because 
subjects will self-direct their own treatment we expect that they will self-monitor and take breaks as 
needed and therefore we do not expect ratings to reach or exceed this level. However, we will 
provide clear instructions that if an RPE rating is above 14, the subject should rest.  
• 
If a client reports pain ≥5 (moderate) on the pain scale, he/she will be instructed to cease the study 
intervention for the day. If the subject reports that pain has been moderate or severe (≥5) for several 
consecutive days, the subject will be counseled to stop the study and to contact his/her physician. 
• 
Any and all adverse events will be reported to the MUSC IRB as per regulations.  
• 
Who will monitor: Subjects will be monitored by research therapist who will phone each subject 
weekly. The research therapist will report on each participant to the study PI weekly, or daily if the 
therapist judges that the subject is having pain or fatigue. The PI and research therapists are 
licensed occupational therapists with extensive experience providing rehabilitation programs to 
persons with stroke. 
• 
Endpoint: For subjects initially randomized to DDP, the study endpoint will be the 30 day follow up 
retention test. For subjects initially randomized to KTS, the study endpoint will be the immediately 
post-DDP play visit which will occur 6 weeks after the 30 day follow up (or approximately 4 months 
from study enrollment). Subjects will be able to terminate the evaluation sessions and/or 
rehabilitation protocol at their request at any time without prejudice.  
 
14.0 
Withdrawal of Subjects  
• 
Subject Withdrawal: 
As participation in this study is voluntary, the subject has the right to withdraw from the study 
at any time for any reason without prejudice to his/her future stroke rehabilitation care. For the 
subject who withdraws consent, the date and reason for withdrawal will be documented. Subject 
data will be included in the analyses up to  the date of withdrawal and no further data will be 
collected.  
• 
Subject removal from the study: 
The PI may stop study therapy if there is a safety concern (e.g., excessive pain/fatigue), if the 
subject fails to attend evaluation sessions or adhere to study procedures. Subject data will be 
included in the analyses up to  the date of withdrawal and no further data will be collected. 

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15.0 
Risks to Subjects 
Repetitive arm motions may cause fatigue or pain: Participation in any movement activity program 
may cause fatigue and/or muscle soreness. As per the procedures described the study therapist 
will phone each participant weekly to monitor fatigue and pain.  
 
Randomization: The subjects will be assigned to a treatment group by chance. The treatment group 
they receive may prove to be less effective than the other activity group.  
 
Loss of confidentiality: Dr. Woodbury’s team will take appropriate steps to protect subject data. 
However there is a slight risk that information could be revealed inappropriately or accidentally. All 
hard-copy information with the subjects name on it will be stored in a locked cabinet in a locked 
office in a secure building at the MUSC (77 President Street, Charleston, SC).  All electronic 
information will be stored in a secured database on the firewall protected MUSC network. No PHI 
will be transmitted outside of MUSC, stored on portable electronic devices, shared or sold at any 
time. All of the data from the test results will be de-identified before it is stored in a research 
database 
 
16.0 
Potential Benefits to Subjects or Others 
 
• 
Although we anticipate that subjects will benefit from this study by gaining arm/hand motor function, 
there is no guarantee of benefit. However others may benefit from our increased understanding of 
how computer games may be used to elicit repetitive practice of arm movement for stroke recovery. 
Future therapies may be improved upon by this knowledge 
 
17.0 
Sharing of Results with Subjects 
• 
Subjects may submit a written request for their arm movement assessment results. This information 
will be provided to them in hard copy form.  
 
18.0 
Drugs or Devices  
• 
DDP has FDA 510(k) clearance (K151446). The clearance notification letter from the FDA 
indicates that the software is cleared “for use with the Microsoft Kinect motion tracking 
system that is indicated to support physical rehabilitation of adults in the clinic and at home 
via performance of therapist-assigned reach exercises for the upper extremities. Patient 
assessment, exercise guidance, and approval by the medical professional are required prior 
to use.” 
References 
 
1. 
Magarik JA, Jauch EC, Patel SJ, Adams RJ, Turner RD, Chaudry MI et al. MUSC's comprehensive 
stroke program: changing what's possible in stroke care across South Carolina. Journal of the South 
Carolina Medical Association 2012;108(5):128-31. 
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