Infusing Robot-Assisted Therapy With Motor Learning Principles: An Active Learning Program for Stroke
Phase: NA
Conditions: Stroke
Sponsor: Spaulding Rehabilitation Hospital

Cover Page 
 
Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke 
 
NCT02747433 
Study Protocol and Statistical Analysis Plan 
 
Document Date: September 14, 2016 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
ORGANIZATION AND DETAILED PROTOCOL 
 
Title: Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning 
Program for Stroke (ALPS) 
 
NCT02747433 
 
Protocol #: 2015-P-002107 
 
Version Date:  9/14/16 
 
PI: Susan E. Fasoli, ScD OTR/L 
 
I. 
Background and Significance 
Stroke is the leading cause of long-term disability in older adults in the United States. At 
six months after stroke, up to 65%1 of the more than 795,000 persons2 who experience a stroke 
each year continue to have upper extremity (UE) impairments that inhibit functional use of the 
paretic arm during daily activities. Stroke-related motor deficits can persist long term, contributing 
to loss of independence in activities of daily living (ADL) in more than 70% of stroke survivors3 
and negatively impacting quality of life. In order to advance rehabilitative practice and optimize 
satisfaction and participation after stroke, improved methods are needed to optimize the recovery 
of UE motor function for home and community activities.  
 
Rehabilitation robots and passive gravity-assist orthoses provide clinicians with new 
treatment options to improve upper extremity (UE) motor capacity and performance after stroke. 
Previous studies have shown that robot-assisted therapy is as effective as more labor-intensive 
interventions at increasing motor capacity, as measured by standardized clinical assessments.4 
While systematic reviews of robot-assisted therapy for the paretic UE confirm gains in motor 
capacity as measured by clinical assessments, they provide little evidence of improved UE 
performance during daily tasks and occupations.5,6,7 This disparity between UE motor capacity 
and daily use of the paretic arm and hand is a significant clinical issue8 and critical barrier to the 
integration of robotic technology into clinical practice. These findings may be attributed to the 
limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity 
of practice with little regard for other principles of motor learning and experience-dependent 
neuroplasticity.9,10 These principles, including the salience of training tasks, transfer of acquired 
skills to similar activities, and active engagement and problem solving, are key to task-oriented 
training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well 
integrated into robot-assisted therapy protocols. The transfer of robot-trained movements to UE 
activities within the home and community needs further exploration before widespread use in 
rehabilitation practice is expected.  
 
The purpose of this pilot project is to develop and refine a stroke therapy protocol that 
infuses robot-assisted therapy with a structured Active Learning Program for Stroke (ALPS) and 
patient-targeted home action plan for the paretic arm and hand. The intent of this protocol is to 
teach stroke survivors ways to better use their weaker arm after stroke during daily activities. This 
project has the potential to improve the effectiveness of robot-assisted therapy by facilitating UE 
self-management through active problem identification and problem solving, and specifically 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
addressing the transfer of acquired skills (e.g. UE motor capacity) to the performance of UE tasks 
during activities of daily living (ADL). The ALPS protocol will be relevant to clinical practice 
because it will provide clinicians with a structured, patient-centered motor learning approach to 
facilitate use of the paretic arm and hand. In addition, comparisons between our two intervention 
groups (robot-assisted therapy vs. robot-assisted therapy [RT] and task-oriented training [RT-
TOT]) will add to our scientific knowledge of whether the combination of robot therapy and 
therapist-directed task-oriented training provides added benefit to RT alone. We will examine 
participant outcome measures across domains of the International Classification of Functioning 
(ICF)11 to provide insights regarding mechanisms that underlie the recovery of motor function after 
stroke.  
 
II. 
Specific Aims 
The specific aims of this pilot study are: 
 
Aim 1: To develop and refine a structured Active Learning Program for Stroke (ALPS) that 
integrates motor learning strategies with a patient-targeted home action plan to be used with 
either 1) robot-assisted therapy (RT) or 2) combined robot-assisted therapy and task-oriented 
training (RT-TOT) for the paretic arm and hand after stroke, in preparation for a larger clinical trial.  
 
Hypothesis 1.1: RT and combined RT-TOT protocols that incorporate ALPS training will 
be feasible and well-tolerated by participants. 
Hypothesis 1.2:  After intervention, participants in both treatment groups will identify and 
implement a greater number of motor learning strategies during UE tasks in clinic and home 
settings and will report increased self-efficacy as measured by the Confidence in Arm and Hand 
Movement (CAHM) scale.   
 
Aim 2: To examine effects of ALPS training and a patient-targeted home action plan combined 
with either 1) RT or 2) RT-TOT on paretic UE motor capacity and performance during daily 
activities, using outcome measures across ICF domains. 
 
Hypothesis 2.1: Compared to RT alone, RT-TOT will yield similar outcomes on clinical 
measures of UE motor capacity (e.g. Fugl-Meyer Assessment, Wolf Motor Function Test), but 
greater gains on measures of UE function in the home and community (e.g. Motor Activity Log, 
UE accelerometry data via wearable sensors).  
 
III. 
Subject Selection 
We will recruit up to 20 adults between the ages of 18 and 82 years and diagnosed with 
unilateral stroke more than 6 months prior to study enrollment. Stroke type will include both 
ischemic and hemorrhagic stroke. Eligible participants will be screened and enrolled in the study 
if they meet all inclusion and exclusion criteria. Protocol approval will be obtained from the SRH 
Institutional Review Board (IRB) and all participants will provide their informed consent prior to 
study participation.  
 
Inclusion criteria:  
• 
Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow & hand and initial 
score on the Fugl-Meyer Assessment (FMA) between 21-50/66)) 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
• 
Intact cognitive function to understand and actively engage in the ALPS robotic therapy 
procedures (Montreal Cognitive Assessment Score >/=26/30)12 during initial evaluation 
visit   
Exclusion criteria:  
• 
No more than moderate impairments in paretic UE sensation, passive range of motion, 
and pain that would limit ability to engage in therapy 
• 
Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;  
• 
Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on 
the Cognitive Linguistic Quick Test 13 
• 
Aphasia sufficient to limit comprehension and completion of the treatment protocol 
• 
Currently enrolled or has plans to enroll in other upper limb therapy/research during the 
study period  
• 
Contraindications for robot-assisted therapy including recent fracture or skin lesion of 
paretic UE 
 
IV. 
Subject enrollment 
 
Recruitment Methods: 
Potential subjects may be identified by the following sources: 
• 
Printed flyers given to rehabilitation departments of local hospitals. 
• 
Flyers posted in the outpatient clinics, therapy gyms and in public spaces inside and 
outside of the hospital. 
• 
The Partners RSVP for health website. 
• 
Contact with support groups and conferences. 
• 
Research recruitment emails, for example Spaulding Rehabilitation Network Research 
Recruitment emails, and Social Medias.  
• 
Contact to patients listed in the Partners Research Patient Data Registry (RPDR).  
• 
Stroke Survivors who previously volunteered to be contacted about opportunities to 
participate in research studies at SRH may be contacted by phone by a study staff. 
• 
Attending physicians and therapists may refer their stroke inpatients/outpatients to the 
study. We will provide the physicians with study flyers.  
 
Eligible patients will contact or give permission to be contacted by study staff to obtain more 
information about the study and informed consent. 
 
At the first point of contact (usually a phone call), study staff will administer a phone-
screening questionnaire to see if subjects are eligible for the study. Potential subjects who are 
deemed eligible during this initial contact will be invited to attend an in-person screening to ensure 
that all inclusion and exclusion criteria are met. If a prospective subject fails this screening, he/she 
will be excluded from the study. 
 
Informed consent will be obtained by study staff members who have completed the 
Partners Healthcare System’s human subject protection educational requirements, and the CITI 
Program in Protection of Human Subjects, in compliance with all Federal regulations regarding 
such training. Prospective subjects will be interviewed to determine preliminary eligibility. 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
Informed consent will be obtained and subjects will be enrolled in the study prior to any clinical or 
laboratory testing. Subjects will be given a copy of the IRB approved consent form during the 
initial interview, and study staff will explain in detail the nature of the informed consent process, 
study purpose and procedures, time commitments, risks, potential benefits, treatment 
alternatives, rights as research participants, study staff contact information, confidentiality 
procedures, and arrangements for medical care provided in case of injury during the study. 
Subjects will be given adequate time to consider their decision and encouraged to ask questions, 
both during the initial interview and throughout the study. The subject’s decision-making capacity 
and ability to give consent will be assessed by the PI (Fasoli) or Catherine Adans-Dester, 
Research Coordinator/Manager in the Motion Analysis Lab at SRH, using the University of California 
at San Diego (UCSD) Brief Assessment of Capacity for Consent Questionnaire. The subject must 
demonstrate an understanding of the study, that it is research, and answer questions re: the risks 
and benefits involved in the procedures.  
 
Specifically, the informed consent will be obtained by the principal investigator (Fasoli) or 
Catherine Adans-Dester, Research Coordinator/Manager in the Motion Analysis Lab at SRH. The 
testing and intervention protocol will be described and the research space and equipment will be 
shown to the subject. Study staff will clearly explain all procedures and risks of the protocol 
outlined in the informed consent form (ICF). The subject will be given adequate time to consider 
his/her decision and encouraged to ask questions, both during the initial interview and throughout 
the study. A member of the study staff will answer any questions regarding the study at the time 
consent is given.  Enrollment will begin when the subject thoroughly understands and signs the 
informed consent form.  Participants will be provided with a signed copy of the completed consent 
form. Once enrolled, the subject may pause or terminate his/her participation at any time during 
the study. Participants will be randomized to one of two treatment groups (robot-assisted therapy 
[RT] or robot-assisted therapy plus task-oriented training [RT-TOT]) according to a randomization 
sequence prepared by Dr. Fasoli. 
 
V. 
Study Procedures 
 
Study procedures will occur in the Motion Analysis Lab (MAL). The study involves up to 24 visits in total to 
be completed within a 16 week period. The total duration may vary within this 16 week period to 
accommodate missed study visits.  
1. MAL Visit Day 1: Screening and enrollment  
2. MAL Visit Days 2-3: Baseline outcomes assessment battery. We will equip participants 
with Actical wearable sensors for home-based accelerometry data collection.  
3. MAL Visit Days 4-21: Intervention. We will retrieve Actical wearable sensors at after 
baseline data collection at the onset of intervention visits.  
4. MAL Visit Days 22-23: End-of-intervention outcomes assessment battery. We will 
equip participants with Actical wearable sensors for home-based accelerometry data 
collection. 
5. MAL Visit Day 24: Follow-up outcomes assessment battery. We will equip participants 
with Actical wearable sensors for home-based accelerometry data collection. 
 
 

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Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
Kinematic data indicative of movement quality will be collected via 3-D motion capture (Vicon 
Motion Systems Ltd. UK) in the Motion Analysis Laboratory (MAL) during reach/grasp tasks 
with the paretic arm. Variables of interest may include index of curvature (IOC) (ratio of actual 
distance the hand travels to the most direct distance), movement smoothness (number of 
times hand trajectory = 0 during reach), trunk displacement (degrees of movement in sagittal, 
planar, and transverse planes), and interjoint coordination (range of angular motion at the 
shoulder, elbow and wrist).17,18 The kinematic testing protocol will be collaboratively developed 
by Dr. Fasoli and Dr. Bonato and his MAL staff. This may include reach and grasp movements 
directed toward targets positioned in front of the subject to elicit functional movements, 
including upward reach, forward reach, shoulder abduction, shoulder rotation, pronation of the 
forearm, wrist extension, and finger flexion/extension. We anticipate that this quantitative 
assessment will require an additional 1-1/2 hour/session at baseline and discharge.  
Surface electromyographic (SEMG) data may be gathered during the kinematic testing 
protocol above to study the characteristics of muscle activation patterns in stroke survivors 
during the performance of arm reaching movements. Data will be collected using Cometa 
WavePlus wireless surface electrodes with 16 channels (www.cometasystems.com) for the 
detection of EMG activity from muscles that are involved in the performance of upper extremity 
movements. We will follow the SENIAM (Surface Electromyography for the Non-Invasive 
Assessment of Muscles) guidelines to place electrodes on several muscles involved in the 
performance of the arm reaching movements. Muscles may include the following: rhomboid 
major, latissimus dorsi, infraspinatus, superior trapezius, deltoid - anterior part, deltoid - medial 
part, deltoid - posterior part, pectoralis major, clavicular head, triceps brachii, lateral/medial 
heads, biceps brachii (short heads), biceps brachii (long heads), brachialis, brachioradialis, 
pronator teres, extensor carpi radialis and extensor carpi ulnaris. The EMG on the back, 
shoulder, upper arm and forearm will be attached using bio-adhesive double sided tape and 
secured with Coban. 
We may ask permission from study participants to video record them during the performance 
of the above-described clinical tests and the lab-based assessments. 
Home Based Accelerometry – Wearable Sensors:  The Actical physical activity monitoring 
system (http://www.philips.com)is a multi-directional, waterproof sensor used to quantitatively 
measure UE activity during everyday living situations. Sensors will be worn on both wrists 
during 72-hour periods at each assessment point to allow comparisons between paretic and 
intact UE activity in the home/community.19 A single page user guide for the wrist sensors will 
be provided to participants, and sensors may be removed at any time due to discomfort. There 
will be no penalty for loss or damage to a wrist sensor, subjects will be given a pre-stamped 
envelope to return the Actical at the end of the 72-hour period. Staff in Dr. Bonato’s Motion 
Analysis Laboratory (MAL) at SRH have used this device and will analyze de-identified raw 
data in order to examine changes in arm movement pre- to post-intervention (e.g. the amount 
and laterality of use).   
 
The proposed assessment timeline is below (Table 1). 
 
 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
ICF Domain/Assessments 
Baseline  Discharge 
1-month 
Follow-up 
UE Function: 
Fugl-Meyer Assessment – UE, pain, sensation subtests 20,21 
Modified Ashworth Scale 22 
MAL: 3-D motion capture/SEMG analysis UE reach/grasp          
                            
  
X 
X 
X 
 
X 
X 
X 
 
X 
X 
 
Activities & Participation: 
Wolf Motor Function Test 23 
Motor Activity Log 24 
Stroke Impact Scale 25 
Confidence in Arm & Hand Movement (CAHM) 26 
Home-Based Accelerometry/Wearable Sensors 
 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
Table 1. Assessment Timeline. 
 
3) MAL Visit Days 4-21: Intervention. Retrieve Actical wearable sensors.  
Participants will be randomly assigned to one of two treatment groups: 
A. Robot-Assisted Therapy (RT) + ALPS protocol to enhance active problem solving, 
confidence in UE use, and transfer of training to functional UE tasks, and all will be 
provided a home action plan. 
B. Robot-Assisted Therapy (RT) + Task-Oriented Training (TOT) + ALPS protocol to 
enhance active problem solving, confidence in UE use, and transfer of training to 
functional UE tasks, and all will be provided a home action plan. 
 
Robot-Assisted Therapy (RT): Participants will receive robot-assisted UE therapy using two 
commercially-available rehabilitation devices available for use at SRH: the Armeo®Spring 
(Hocoma AG, Switzerland) and Amadeo (Tyromotion. Graz. AU)(Figure 1). The Armeo®Spring is 
a passive exoskeletal spring suspension system that provides repetitive practice of virtual goal-
directed reaching tasks for the paretic UE. A distal sensor that detects grasp pressure allows the 
grasp/release of virtual objects during games. The amount of gravity assist and virtual task 
demands are adjusted by the clinician to provide challenging yet achievable movement therapy. 
During the first treatment session, the Armeo®Spring will be adjusted for the participant’s arm 
size and required angle of suspension (approximately 45° shoulder flexion, 25° elbow flexion) and 
the workspace will be measured via standard procedures.  
 
The Amadeo robotic system provides position-controlled exercises during computerized games 
that emphasize grasp and release of the paretic hand.  Participants will be seated comfortably 
with the forearm/wrist strapped to an adjustable splint attached to the robot device with the wrist 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
in approximately neutral position. A small magnetic disc is secured to the distal phalanx of each 
digit for connection to the robotically controlled 
slide that guides movement. Each one hour 
session will include visually evoked games that 
provide active-assistive training of collective, 
sequential and individual flexion and extension 
of 
the 
digits 
as 
well 
as 
isometric 
flexion/extension contractions. Rest periods 
will be offered between games, as needed. 
Task challenge for each training device will be 
incrementally increased or decreased based 
on participant performance.  
 
All participants will receive 1 hour sessions, 2-
3x/week for 6-9 weeks (total 18 sessions), 
divided into two 9 session treatment blocks. The two treatment blocks will be given in order, with 
all participants receiving proximal training via Armeo®Spring during the first block followed by 
Amadeo distal training during block 2. All training sessions for one treatment block will be 
completed before proceeding to the next. The robot training sessions will follow standard 
protocols that provide highly repetitive movement training, and the number of games/repetitions 
completed in each session will be recorded. Participants may miss up to 3 appointments, and we 
will reschedule the following day or week at a time that is mutually convenient. Participants who 
miss 4 consecutive appointments may be removed from the study.  
 
Active Learning Program for Stroke (ALPS): ALPS development and implementation will be 
based upon principles of experience dependent neuroplasticity as described by Kleim & Jones;9 
empirical evidence from UE motor learning and task-oriented training programs for individuals 
with stroke;10,27,28 and a conceptual framework for integrating skill, capacity and motivation as 
described in multiple publications by Winstein et al.10,29,30 While principles of repetition, intensity, 
and specificity of training are active ingredients of the RT and RT-TOT protocols to improve motor 
capacity, other motor learning constructs have not been well-infused into prior robot training 
programs. These constructs will be implemented during RT and RT-TOT sessions and will be an 
integral component of the home action plan. Preliminary examples of protocol components are 
highlighted in Table 3 below. 
 
Motor Learning Principles 
Example 
Use it or lose it 9,10,27 
 
Identify interfering and changeable impairments 
Provide targeted UE training based on individual’s 
motor capacity 
Salience of training tasks 9,10 
Establish clear patient-centered goals 
Transference 9,10 
Facilitate UE self-management through active 
problem identification and problem solving  
Feedback 28,31 
Provide knowledge of performance 
Encourage self-assessment and discovery 
Motivation 10,29,30 
 
Assure challenging and meaningful practice 
Address self-efficacy and confidence 
Table 3. ALPS Motor Learning Principles. 
 
Task-Oriented Training (TOT): Participants randomized to the robot and task-oriented training 
(RT-TOT) group will receive therapist-guided task-oriented training in addition to RT during 20-30 
 
Figure 1. Armeo and Amadeo. 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
minutes of each 1 hour treatment session. The participant’s baseline performance on the FMA 
will be reviewed, and the FMA keyform and patient-targeted treatment activities outlined by 
Woodbury 32,33 may aid the selection of UE tasks with greatest potential for improvement during 
TOT. The treatment dose (duration and frequency of therapy sessions) will be equivalent across 
RT and RT-TOT groups. 
  
Home Action Plan: All participants in the RT and RT-TOT groups will be provided a home action 
plan to encourage implementation of ALPS principles during practice of patient-targeted tasks in 
the home and community. 
 
The tasks selected for the home action plan (HAP) will be based on the participant’s identified 
upper extremity (UE) goals and/or therapist input based on a) the current focus of robot therapy 
(i.e. shoulder/elbow, hand) and b) scores on the FMA key form. Because of this participant-
centered approach there will be no core tasks included in every HAP, however, similarities may 
be observed across individuals. Participants will identify an UE task to be completed at home and 
the ALPS strategy or strategies they will use to facilitate performance weekly. A brief self-report 
questionnaire to collect ordinal data on ALPS strategy use, HAP performance, frequency, & 
perceived difficulty will be administered by research staff after every 3rd therapy session. 
Participant’s engagement in the home action plan will be rated using a 3 point Likert type scale29 
and patient-targeted UE tasks will be updated as needed. A similar questionnaire will be 
administered during the follow-up assessment to gain information regarding the participant’s 
engagement in home practice after formal therapy has ended. Participants will be instructed that 
completion of the HAP is voluntary and will not affect their therapy in any way. The intent of the 
HAP is to provide documentation of home carry-over. It is not designed to be a comprehensive 
home exercise program.  
 
 
4) MAL Visit Days 22-23: End-of intervention outcomes assessment battery 
(administered at discharge assessment after 18 treatment sessions) Equip with Actical 
wearable sensors.  
 
The same assessment battery as the one performed at baseline will be re-administered. 
 
5) MAL Visit Day 24 (Final Visit): Follow-up outcomes assessment battery 
(administered at 1 month post-therapy) Equip with Actical wearable sensors.  
The same assessment battery as the one performed at baseline will be re-administered, except 
for the Motion Capture and EMG analysis.  
 
VI. 
Biostatistical Analysis 
 
Separate repeated measures analyses of variance (2 group x 3 time points) will examine 
changes in scores for each outcome measure across a) baseline, b) discharge and c) follow-up 
assessments. Descriptive statistics will be used to compare key group characteristics, including 
age, hand dominance, side of lesion, and years of education. Group comparisons will be 
assessed by chi-square analyses for categorical data and t-tests for continuous data. The data 
collected from this pilot study may be used for a power analysis of a larger clinical trial.  
 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
VII. 
Risks and Discomforts 
 
Subjects will not be at higher risk for injury during the research protocol than during their 
usual daily activities, and they will be supervised by study staff at all times during study 
assessments and intervention procedures. Staff in Dr. Bonato’s MAL and Dr. Fasoli have 
extensive experience with the measurement tools (e.g. motion capture, wearable sensors) and 
intervention devices (Armeo & Amadeo) used in this study, and have maintained excellent safety 
records at SRH and at institutions outside the Partners network. Research staff will be trained in 
the proper use of all study devices prior to use with participants to assure safety. Potential risks 
and discomforts are described below: 
During the camera-based motion analysis assessments, it is possible that the use of 
adhesive tape to secure reflective markers or electromyographic sensors to the skin may cause 
skin irritation. We will minimize this risk by using hypoallergenic adhesive tape approved for 
medical use. 
 
The Actical wearable sensors used in this study are powered by low voltage batteries and 
are completely isolated from other electrical sources such as power lines. Black velcro straps 
from the manufacturer will be used to secure the sensors to the participants’ wrists. For persons 
with sensitive skin, we will modify these straps with Velfoam strapping as needed to increase 
comfort and prevent skin irritation.  
 
All laboratory equipment meets or exceeds hospital standards for electrical safety. 
Robot-assisted therapy with the Armeo device is very unlikely to cause injury as the Armeo has 
no actuated components. The straps of the device may cause redness of the skin. We will assure 
proper upper limb positioning during intervention and will pad the straps as needed so they are 
comfortable for the subject.  
 
Unlike the Armeo, the Amadeo is equipped with actuated components (i.e. motors) 
capable of independent motion. As stated in the manufacturer’s instruction manual, risks are 
minimal when the Amadeo is used according to instructions. Small injuries, such as pinching or 
bruising can occur in rare cases, however, numerous safety features and procedures have been 
implemented to minimize risk of injury. These include a system controller designed to avoid 
excessively fast movements of the fingers/thumb; safety limits set for the estimated interaction 
forces during finger motions, and two emergency switches to immediately shut off robot power in 
the event of a malfunction. Height adjustments of the Amadeo will be performed with caution so 
injury does not occur when lowering the device to ensure proper positioning for therapy. We will 
ensure that fingers are not in contact with the finger slides during reference runs when initializing 
the device. During intervention, small magnets are attached to the subject’s fingers and thumb 
via medical tape to provide a safe and easily removed connection to Amadeo’s actuated finger 
slides. This tape can be replaced by custom made velcro or velfoam strips in the event of skin 
irritation or discomfort. During task-oriented training in which subjects are asked to perform 
several sets of common, task-oriented movements, it is possible that they will feel discomfort due 
to fatigue or muscle soreness as they increase their tolerance to exercise. During robot-assisted 
therapy and task-oriented training, participants may take rest breaks as needed to minimize 
possible fatigue or muscle soreness following multiple repetitions of upper limb movements.  
 
VIII. 
Potential Benefits 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
Potential benefits of robot-assisted therapy for the paretic arm after stroke include 
reductions of motor impairment however, the transfer of robot-trained movements to UE activities 
within the home and community has not been well studied. The proposed study aims to develop 
and refine a stroke therapy protocol that infuses robot-assisted therapy with a structured Active 
Learning Program for Stroke (ALPS) and patient-targeted home action plan. If successful, it has 
good potential to improve the effectiveness of robot-assisted therapy by facilitating improved self-
management of the paretic arm and specifically addressing the transfer of acquired skills (e.g. UE 
motor capacity) to everyday UE tasks. These methods could benefit rehabilitation practice by 
providing clinicians with a structured motor learning approach to enhance recovery of UE function 
during stroke intervention.  
 
IX. 
Monitoring and Quality Assurance 
 
Approval of protocol, informed consent procedures, and recruitment will be obtained from 
the IRB during annual reviews.  Because this study’s procedures pose relatively low risk to 
subjects, monthly data and procedural reviews by the PI and/or site responsible investigator (Dr. 
Bonato) in consultation with study staff will be sufficient to identify and ameliorate any potential 
safety issues.  However, any safety concerns about the exercise equipment or clinical protocol 
will be brought to the attention of the P.I. at the time they occur, and immediate action will be 
taken. Dr. Fasoli and Dr. Bonato will be responsible for determining whether the research should 
be altered or stopped in the event that participant safety is at risk. 
 
Study staff will report any adverse event within 24 hours to the PI.  A written report will be 
submitted to the IRB within 48 hours.  Remedial action to prevent reoccurrence of the event will 
be instituted prior to resumption of study procedures. Compliance with regulatory standards for 
study documentation will be closely monitored by the PI. 
Study staff will conduct quarterly audits to ensure compliance with regulatory standards to 
assure the integrity of study documentation and adherence to the IRB-approved protocol. 
Specifically, the accuracy and completeness of case report forms, source documents and 
informed consent forms will be audited by study staff under direct supervision of the PI (Fasoli). 
Although the study evaluator (Adans-Dester) is highly experienced with the administration and 
scoring of the outcome measures used in this study, the PI will review test administration 
procedures with her at study onset and quarterly thereafter to ensure proper use of standardized 
testing procedures.  
 
Subjects will be assigned a study number, which will be used for all documentation, except 
for master lists (electronic and paper) matching subjects’ names and study numbers and intake 
interview forms.  The master list and interview forms will be kept in a secure location in locked 
offices at SRH.  No non-study staff will have access to any identifiable patient study data or 
demographic information.  All participants will be informed of their privacy rights and sign a HIPAA-
compliant authorization form previously approved by the Spaulding IRB. All videotapes of 
assessment sessions will be stored securely in the Motion Analysis Laboratory at Spaulding 
Rehabilitation Hospital; only investigators listed on the study application will have access to them. 
The videotapes will be stored for the duration required by NIH standards; should NIH standards 
change prior to destroying the tapes, we will adhere to new regulatory standards. 
 
 
No personally identifiable data will be sent to or viewed by collaborators outside of SRH 
or MGH Institute of Health Professions (Dr. Fasoli’s home institution).  Only co-investigators and 
study staff will have access to the data from the study.  Study data will be maintained on 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
computers with password-codes accessible only to study staff, and hard data will be kept in locked 
cabinets and offices at SRH.   
 
 
 

Infusing Robot-Assisted Therapy with Motor Learning Principles: An Active Learning Program for Stroke (ALPS)   
Susan Fasoli ScD OTR/L  
 
 
 
 
 
 
 
 
 
 
 
 
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