A Novel Therapy + E-learning Self-management Program for Stroke Survivors
Phase: NA
Conditions: Stroke
Sponsor: Medical University of South Carolina

E-learning+ Rehab Therapy (TEAACH) 
NCT04245449 
Document Date 08/14/2019 

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PROTOCOL TITLE: 
A novel therapy + e-learning self-management program for stroke survivors 
 
PRINCIPAL INVESTIGATOR: 
Michelle L. Woodbury OTR/L, PhD 
 
 
 

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1.0 
Objectives / Specific Aims 
 
Our central premise is that survivors must engage in more in-home paretic arm use and less non-
paretic arm use because real world use drives neural plasticity more than the limited therapy visits 
available. We argue that survivors do not use the paretic arm outside of the clinic to maximize 
beneficial plasticity because post-discharge support from the rehabilitation team is limited, thus 
survivors do not fully understand why or how to use the paretic arm at home. Although current 
in/outpatient rehabilitation provides basic education about stroke and managing impairments, 
current rehabilitation practice does little to empower stroke survivors with knowledge or skills; 
specifically, knowledge of the neurobiological processes causing the impairment and the requisite 
skills to manage their own long-term recovery. Our unique interprofessional research team, 
comprised of experienced stroke rehabilitation providers and a nurse scientist, are award-winning 
educators and passionately believe that survivors can improve outcomes if supported with 
knowledge and skills.  
 
Hence, we created a first of its kind multimodal therapy + e-learning program called Training to 
Empower Activity-dependent-plasticity-based Arm-use-habits in the Community and at Home 
(TEAACH).  Here we test its implementation:  
 
AIM: Implement the TEAACH program 
Rationale: Online training to improve post-discharge self-management skills in community dwelling stroke 
survivors is a new concept, therefore there is a need to test the feasibility of this approach. Method: 
Twelve (n=12) survivors ≥3 months post stroke with moderate arm motor impairment, will be 
enrolled in TEAACH.  TEAACH is a cutting-edge therapy + e-learning program designed to 
gradually transition the stroke survivor away from therapist-management to self-management of 
long term stroke recovery. TEAACH will have 3 essential components; a behavioral contract 
signed before the program begins to assure that its focus is explicit in survivors’ minds; direct 
therapist contact for 3 months (3 months in-clinic therapy with  online guidance); and online course 
activities guided by rehabilitation professionals to engage learning and peer mentorship.  
 
SA1: Determine the feasibility of implementing the TEAACH program: 
The primary endpoint will be a determination of the feasibility of the e-learning + therapy program. 
Primary outcome will be feasibility defined as (1) subjects’ level of engagement in the program, 
(2) acceptability, (3) technological literacy, and (4) practicality. Data will be analyzed qualitatively.  
 
SA2: Determine the initial efficacy of TEAACH: 
Early indication of efficacy will be determined by TEAACH-related changes in measures of (1) 
self-confidence and social support, (2) self-management skills, and (3) paretic arm impairment 
and at-home paretic arm use. Changes scores will be calculated to detect a treatment effect 
measured from baseline (pre-TEAACH) to post TEAACH (3 months), and at 5-months to assess 
retention.  
 
Impact: This project addresses a critical gap in the field because it innovatively addresses 
survivors’ skills needed to be the self-managers of their own recovery for the long term. TEAACH 
has an online platform which means that it could be immediately incorporated into clinical practice, 
modules could be added to meet other needs such as ongoing wellness education, or it could 
easily be redesigned to meet similar needs in other patient populations.  
 

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2.0 
Background 
 
A. SIGNIFICANCE  
A.1. Arm paresis from stroke is a long-term impairment that reduces quality of life: Most 
stroke survivors, >75%, exhibit upper extremity (UE) hemiparesis, and only 15% recover fully.1,2 
The majority of daily activities require 2 hands,3 thus paresis of one hand reduces independence4 
and quality of life.5  
A.2. Paretic arm movement can improve during in-clinic 
therapy, but survivors fail to use the paretic arm outside 
of the clinic: Intensive task-practice therapies enable 
survivors to recover UE skill.6-8 But, as shown in Figure 1 
patients demonstrate persistent hyper-reliance on the non-
paretic arm for daily activities.9-11  
A.3. Non-paretic arm use is a behavioral compensatory 
strategy: The natural response to impairment of one arm is 
to compensate by using the other arm for critical life activities. 
Survivors learn compensatory strategies from rehabilitation 
therapists12 and a variety of self-help resources.13  
A.4. Over reliance on the non-paretic arm is a behavioral manifestation of an underlying 
activity-dependent maladaptive plasticity that harms 
paretic arm recovery: Repeated behaviors are supported 
through increasingly more efficient neural networks.14 
Rodent stroke models link non-paretic limb use to increased 
neural excitability in the non-lesioned hemisphere through a 
growth response in the basilar dendrites of pyramidal 
neurons15 which triggers new inter-cortical trans-callosal 
connections16 resulting in synaptic reorganization in areas 
that should be associated with paretic arm use.17-19 In other 
words, non-paretic limb use elicits activity-dependent 
plasticity processes that hijack neural reorganization of 
motor networks that otherwise could support paretic limb 
recovery 20 Human TMS studies show that an imbalance 
between the hemispheres and continued maladaptive 
processes are strengthened by ongoing use of the non-paretic arm. By continuing to exclusively 
use the non-paretic arm survivors are impeding their own paretic arm recovery (Figure 2). 
A.5. With paretic arm recovery as the goal, survivors 
must extensively use the paretic arm to reverse 
maladaptive plasticity and drive beneficial plasticity:  
Therapy alone does not elicit a high enough movement dose 
for beneficial plasticity21 because the duration of therapy 
programs22 and sessions23 are limited. To effectively 
actualize restorative plasticity within the constraints of our 
current healthcare system, more paretic arm use must 
happen in the home because therapy alone is not/cannot be 
enough. Our hypothesis is that patient self-directed in-
home paretic arm use drives neural plasticity more than 
the limited therapy visits available (Figure 3). However, 
there are very few effective in-home programs24 except the 
“transfer package”28 element of a Constraint Induced Therapy (CIT)8 program.25 The transfer 

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package is a set of behavioral techniques designed to explicitly address clinic-to-home skill 
transfer including behavioral contracts and therapist-led daily conversations to identify and 
overcome perceived barriers to at home arm use.25,26  However, CIT is resource-heavy and is not 
clinically feasible. A new model of patient-driven in-home therapy is needed. 
 
 
3.0 
Intervention to be studied (if applicable) 
 
The 3-month intervention studied is called Training to Empower Activity-dependent-plasticity-
based Arm-use-habits in the Community and at Home (TEAACH).  TEAACH has two 
components: An Online Educational Course and an In-Clinic Rehabilitation Therapy Program.  
 
The TEAACH design and testing timepoints 
are indicated in the figure to the left. Subjects 
will be tested (see below) at enrollment 
(Baseline, evaluation timepoint 1, E1)), at the 
midpoint of the therapy + online program (1.5 
months, E2), immediately following the in-clinic 
therapy + online program (3 months, E3), and 
2 months after the program for follow up (5 
months, E4).  
 
TEAACH e-learning: 3-months of online educational modules include neuroscience education 
(based on an effective pain educational model37) to improve patient self-efficacy, and strategy-
training38 to improve patients’ problem-solving abilities for at-home arm use. The course is live on 
the MUSC MoodleCE platform. 
 
TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 
times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement 
repetitions per session. In our RCTs, this therapy dose required ~1.0-1.5 hours/session. A critical 
element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm 
use via MoodleCE Learning Activities. 
 
 
Enrollment:  Subjects will begin TEAACH in groups of 4 (ideally. However, as per enrollment 
logistics, the groups may range from 3-5 subjects). The purpose of group enrollment is to afford 
opportunity for peer-to-peer interactions within the online learning environment. Peer interactions 
are strongly beneficial for behavioral change and learning.39 As shown in the above timeline, 
each group of subjects enrolled will form their own “section” of the online Moodle course. New 
subjects, in groups of 4, will be enrolled every 2 months forming a separate course section. The 
purpose of forming new course sections is to assure that the course does not have to pause to 
allow new enrollees to “catch up.” Also, overlapping sections allows peer mentoring by having 
participants who are at a certain stage of health behavioral change mentor other participants who 
are at another stage of change. Mentor/mentee activities have been built into the course activities.  
 
Orientation to the Moodle Learning Platform and the Behavioral Contract: At the baseline 
evaluation session (E1), subjects will be oriented to the TEAACH program and its expectations 
month 1
month 2
month 3
month 4
month 5
month 6
month 7
month 8
month 9
month 10
month 11
month 12
Group1 f/u tests
TEAACH Group 2 (n=4) 
Group2 f/u tests
TEAACH Group 3 (n=4)
Group3 f/u tests
N=12
TEAACH Group 1 (n=4)

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via an in-person orientation session. They will be shown how to access the Moodle Online Course 
through the MUSC secure network using either a computer, tablet or phone. Although we intend 
to have participants use their own preferred device and wifi connection, the budget includes 
monies for 10 tablets to afford opportunity for subjects without technology to participate. Security: 
The MUSC MoodleCE platform is behind the MUSC firewall and will allow password protected 
access only to the research team and participants enrolled in TEAACH. The investigative team 
has extensive experience with the Moodle platform. Once oriented to the TEAACH program 
subjects will sign a behavioral contract (akin to the course syllabus) that clearly outlines the 
program goals, scientific premise and expected behaviors. A behavioral contract is considered a 
critical element of a “transfer package” method to enhance real-world use of the paretic arm.37 
 
 
Theory guiding TEAACH e-learning design and implementation: Every aspect of the course has 
been thoughtfully designed for consistency with current theories of health behavior change 
(Transtheoretical Model)60 and methods of instructional design (Constructivism operationalized 
as the revised Blooms Taxonomy).61  To our knowledge we are the first to fit theories from the 
typically disparate fields of health behavior and education into a framework guiding a stroke 
rehabilitation program. Stroke survivors do not use their paretic arm during non-clinic times, a 
learned behavior with a maladaptive plasticity substrate. Increased use of the arm to elicit a 
beneficial activity-dependent plasticity to support further arm recovery requires that the survivor 
undergo a behavioral change, from paretic arm dis-use to paretic arm use. New patterns of 
behavior must be learned, i.e., must be taught.  The Transtheoretical Model of Health Behavior 

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Change60 defines 5 stages of behavioral change, which applied to stroke survivors are; (1) 
precontemplation, a stage in which stroke survivors are unaware of the negative neural 
consequences of ongoing paretic arm disuse, they await the rehabilitation team’s intervention to 
provide a “cure”, and thus have no reason to drive their own long term recovery; (2) contemplation: 
through the interactions with study team and peers, survivors become aware of the need to self-
manage paretic arm recovery but may be ambivalent and lack self-confidence; (3) preparation: 
as the course and in-clinic therapy sessions begin, survivors take small steps toward self-
management as they begin to develop skills and intentional behaviors; (4) action: as the course 
gets underway the survivor overtly engages in paretic arm use both in-clinic and at home as 
he/she acquires the new skills needed to manage arm use; (5) maintenance: the survivor 
demonstrates sustained self-management skills, is able to use his/her paretic arm in daily life 
activities. The educational theory of Constructivism,61 operationalized in the revised Bloom’s 
Taxonomy, provides an overall framework from which to develop learning activities to progress 
survivors through the 5 stages of change. Constructivist theorists propose that learning is 
optimized when the learner seeks to accomplish a clear goal then engages in a problem-solving 
process to achieve that goal.  As the learner iteratively engages in this problem solving process, 
he/she receives feedback from him/herself, instructors and peers about his/her skill or 
understanding which empowers the learner to construct his/her own knowledge.62 The revised 
Booms Taxonomy operationalizes Constructivism principles with verbs to indicate progressively 
more complex problem solving learning processes. Bloom’s taxonomy guided TEAACH learning 
objectives and learning activities.  
 
TEAACH MoodleCE Course Organization: The table above presents the course organization. 
There will be 6 instructional units (A-F) incorporated into this 3-month e-learning course. Each 
unit is tailored to a stage of behavioral change. Columns 1-3 illustrate how course units relate to 
stages of behavioral change and instructional design processes. Example learning objectives 
(column 4) and learning activities (column 5) show the link to the corresponding stage of 
behavioral change. Each unit’s learning activities will leverage various features of the Moodle 
platform to address the unit objectives through engaging learning activities to (a) develop 
survivors’ knowledge of concepts and facts about stroke recovery and (b) enable acquisition of 
survivors’ problem-solving skills for paretic arm use. 
 
TEAACH In-Clinic Therapy:  Subjects will receive 24 in-clinic Targeted Task Practice rehabilitation 
sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2), 1 time/week 
for 4 weeks (month 3) with 
200 movement repetitions 
per session which, in our 
recently completed RCT of 
this intervention, required 
~1.0-1.5 
hours/session, 
consistent 
with 
the 
literature.57 The content of 
the therapy sessions will 
be individualized according 
to each participants’ score 
on 
the 
Fugl-Meyer 
Assessment of the Upper 
Extremity 
Keyform 
according 
to 
the 
procedures followed in our 

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previous VA Merit Award, and that we have published.58  We call this therapy approach Targeted 
Task Practice. The distinguishing feature of this intervention is that the Fugl-Meyer Assessment 
of the Upper Extremity (FMA-UE) Keyform is used to individualize the content of therapy sessions 
to assure that all task-practice will occur at the optimal level of difficulty for each patient. The 
procedure for using the keyform to individualize treatment sessions is illustrated above as a 4 
step process which is also detailed in a recent publication.58 (1) First, the FMA-UE54 will be 
administered in a standardized manner and videotaped. The therapist will score the FMA-UE by 
circling item ratings on the keyform. (2) Second, the therapist will identify the transition zone by 
following the consistent pattern of ratings at the bottom of the keyform upwards until it deviated to 
the next lower adjacent rating (e.g., from a rating of 2 to 1, or from a rating of 1 to 0). This deviation 
will mark the lower boundary of the transition zone which is defined as the first 5 consecutive 
items for which 3 of these items received the next lowest rating. These 5 items represent the 
expected next steps in the subject’s transition from a current skill level to a greater skill level,58  
therefore they will be the movements to target in the task practice therapy sessions. (3) Third, to 
assure the functional relevance of the rehabilitation program the 5-transition zone paretic arm 
motions will be practiced within the context of functional activities so that they will not be 
disconnected from their functional application. In our previous Merit project, we developed a 
detailed study-specific Treatment Activity Menu which links each of the 30 FMA-UE voluntary 
movement items to functional tasks that primarily require the item’s arm movement. We will use 
this manual in the proposed study. The therapist and subject will collaborate to identify 2 functional 
activities from the Treatment Activity Menu for each of the 5 target movements identified by the 
keyform transition zone (total of 10 functional activities).  An example of this menu is shown in the 
figure. As shown, the menu links the FMA-UE item “scapular retraction” to the functional tasks 
“Donning a long-sleeved jacket” and “household cleaning” because the tasks naturally require 
repetition of the targeted movement. (4) Finally, as shown in the photos, subjects will perform 20 
repetitions of each movement target within each functional activity for a total of 200 
repetitions/session. The number of repetitions is based on work indicating its feasibility, safety 
and effectiveness.46  The process of scoring the keyform, locating the transition zone, identifying 
targets and choosing functional activities required ~15 minutes in our previous studies. To assure 
systematic task difficulty progression throughout the in-clinic program, subjects will be reassessed 
with the FMA-UE keyform weekly to identify new therapy targets and functional activities. The 
expectation is that as ability increases, the keyform transition zone will shift upwards to identify 5 
new, slightly more difficult targets.  
 
Assurance of patient safety during in-clinic sessions: Therapy sessions will be conducted by a 
licensed occupational therapist. Heart rate and blood pressure will be recorded before, during and 
after each session and the study therapist will closely monitor the subject for possible pain or 
fatigue. In previous work we demonstrated that the functional tasks practiced in a session were 
at a difficulty level that matched or slightly exceeded the subjects’ movement ability level,59 
therefore we do not expect that the patient will show movement compensations. To further assure 
that movement compensations do not emerge and cause pain or injury, aspects of each task such 
as object weight, speed of performance or surface heights will be manipulated by the therapist.  
 
A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world 
paretic arm use via MoodleCE Learning Activities:  In-clinic therapy for TEAACH subjects will 
incorporate “guided training” methods into the task practice therapy sessions to elicit survivors’ 
self-reflection and self-efficacy. Guided training63 is an emerging, effective method to train 
independent problem-solving abilities via self-instruction, self-monitoring, self-evaluation, and 
self-rewarding. The therapist will teach a “goal-plan-do-check” process, which will then be 
practiced throughout therapy. Specifically, before the start of each functional task, with the 

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assistance of the therapist as needed, participants will instruct themselves what to do (set goal) 
and how to do it with the paretic arm (develop a plan). The subject does the task and then checks 
whether the plan worked. For example, if the task is to “set the table” the subject would identify 
the goal (put the plates there, and the cups there) and how to accomplish it (by reaching forward 
and straightening my affected arm). After doing it, the therapist will prompt the participant to 
register if they (1) used the paretic arm, (2) used it in the specified manner (targeted motions), (3) 
could do it better or differently the next time, and (4) give one’s self a pat on the back if it was 
done well. This process will be repeated iteratively throughout in-clinic sessions and progressively 
faded over the 3 months in-clinic program. MoodleCE assignments will reinforce guided training. 
For example, a discussion board activity will ask participants to reflect on one’s skill implementing 
the 
guided 
training 
strategy, 
a 
mentor 
meeting 
will 
center 
sharing 
one’s 
own 
successes/challenges in implementing this strategy, and a video forum will show examples of this 
process in action.  
 
4.0 
Study Endpoints (if applicable) 
 
Primary Endpoint: The primary endpoint will be determined in Specific Aim 1, the baseline to post 
intervention feasibility of the e-learning + therapy program.  Outcome measures will include baseline to 
post intervention changes in participant scores on assessments of health literacy and technological literacy 
as well as their overall qualitative experiences.   
 
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
 
Inclusion Criteria: (1) paresis of one arm/hand because of ischemic or hemorrhagic stroke >2 
mo. and <3 yrs prior; (2) moderate arm impairment defined as a baseline Fugl-Meyer Assessment 
of the Upper Extremity31 score of at least 32±2 points but no more than 47±2 points (out of 60 
points32) based on published impairment categories33; (3) Montreal Cognitive Assessment34 score 
≥22 to assure that the cognitive capacity to benefit from this learning-based intervention; (4) the 
ability to read English; (5) the ability to communicate as per the therapists’ judgement at baseline 
testing; (6) are 21-90 years of age; (7) have a wi-fi connection in the home and either a computer, 
smartphone or tablet.  
 
Exclusion criteria: (1) lesion or injury to brainstem or cerebellum because lesions in these 
locations may interfere with learning; (2) other neurological disease that may impair motor or 
learning skills (e.g., Parkinson’s Disease); (3) pain interfering with reaching; (4) uncorrected vision 
making it difficult to read information on a computer, tablet or phone. 
 
6.0 
Number of Subjects 
N=12 
7.0 
Setting 
 
All in-person testing, and therapy research activities will occur in Dr. Michelle Woodbury’s 
College of Health Professions upper extremity motor function research laboratory located in the 
CHP Research Building at 77 President Street. Dr. Woodbury’s research laboratory is in the 
same building as the other research laboratories in the MUSC NIH Center of Biomedical 

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Research Excellence (COBRE) in Stroke Recovery.  The e-learning course will occur on the 
MUSC MoodleCE Learning Management System.  
 
8.0 
Recruitment Methods 
 
Participants with stroke will be recruited from the MUSC NIH Center for Biomedical Research 
Excellence (COBRE) in Stroke Recovery stroke research recruitment registry called RESTORE 
(approved MUSC IRB #37803). The Registry currently contains the contact information for ~800 
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 supports information technology resources 
needed to maintain/update the Registry’s infrastructure as needed.  
 
9.0 
Consent Process 
 
The study project coordinator will work closely with the COBRE in Stroke Recovery’s 
recruitment core. The study project coordinator will query the COBRE research registry 
according to the inclusion criteria for the present proposal. He will identify potential participants 
that meet inclusion criteria and inform the PI, Co-I, or study therapist who will contact 
participants by phone to determine if they want to participate in the current study. If they wish to 
participate they will be scheduled for a time for the PI, Co-I, research therapist or project 
coordinator to obtain informed consent for the study proposed.  Consent will be obtained after 
reviewing the protocol and consent form with each potential subject. If a potential subject is 
deemed unable to participate in informed consent as per the judgement of the PI, co-I, study 
therapist or project coordinator, consent will be obtained from a legally authorized representative 
with the patient present. For patients consenting themselves, every attempt will be made to 
have a relative present during the informed consent. All recruitment and informed consent 
procedures will be approved by the MUSC IRB.  
 
10.0 Study Design / Methods 
 
Study Design: This is a longitudinal cohort design.  
 
Research Methods: All study procedures are for research purposes, that is, there are no non-
research evaluations or interventions.   
 
Intervention Methods and Location: The e-learning and stroke rehabilitation therapy 
intervention to be studied is described above in section 3.0.  All in-person procedures will occur 
either in the PI’s stroke rehabilitation research laboratory (College of Health Professions, 77 
President Street). The e-learning intervention will occur via a MoodleCE online learning 
platform.  
 
Duration of Subjects’ Participation: After enrollment, subjects will participate in a 3-month e-
learning + in-clinic stroke rehabilitation program.  Subjects will complete a follow up assessment 
~60 days after the end of the 3-month program.  Thus, subjects will be involved with this study 
for 5 months.   
 
Audio and Video Recording:  

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• Audio Recording:  Each subject will participate in 3 focus groups; one at baseline, 
immediately following the end of the 5-month intervention, and at the post-intervention 
follow up.  The purpose of the focus groups will be to understand the participants’ 
experiences with regards to the feasibility of the program and changes in his/her self-
management skills. Each focus group will be audio recorded. The audio recording will be 
transcribed. The transcription will be analyzed using qualitative data analyses techniques 
to ascertain thematic data.  
• Video Recording:  Subjects will be video recorded during administration of two arm 
movement tests: the Fugl Meyer Assessment of the Upper Extremity and Wolf Motor 
Function Test.  Trained assessment raters who are blind to testing time point will score 
the assessments from the video tapes.  All videos will be stored on secured, password 
protected servers behind the MUSC firewall.  The procedure for training raters and 
scoring from videos was developed in the PIs research laboratory and has been used in 
past and ongoing stroke rehabilitation research clinical trials. Of note- the only people 
having access to the videos are laboratory personnel who have been approved by the 
IRB to be part of this study, and who have completed all required IRB privacy and 
university training.  
 
Primary and Secondary outcome measures are identified in the schedule of events table 
below.  
 
Measurement 
Construct  
Assessment method 
Baseline 
(E1) 
Mid 
(E2) 
Post 
(E3) 
Follow up 
(E4) 
SA1: Primary Endpoint: Feasibility 
Health Literacy 
Short Assessment of Health Literacy 
X 
 
X 
 
Tech Literacy 
Technology Literacy self-evaluation 
X 
 
X 
 
Participants’ 
experiences 
Qualitative (focus group) 
X 
 
X 
 
SA2: Secondary Outcomes: Initial efficacy in the following areas: 
SA2a. Effect on self-confidence and social-support  
Self-Efficacy 
PROMIS Self-Efficacy for 
Managing Daily Activities 
assessment 
X 
 
X 
X 
Social Isolation 
PROMIS Social Isolation 
assessment 
X 
 
X 
X 
Emotional Support PROMIS Emotional support 
assessment 
X 
 
X 
X 
SA2b. Effect on self-management skills 
Self-Management 
Skills 
Qualitative (focus group) 
X 
 
X 
X 
SA2c. Effect on arm movement abilities 
Arm movement 
Impairment 
Fugl-Meyer Assessment of the 
Upper Extremity (FMA-UE) 
X 
X 
X 
X 
Arm motor 
function 
Wolf Motor Function Test (WMFT) 
X 
X 
X 
X 
Paretic arm use in 
the home 
Wrist Worn Accelerometry 
X 
X 
X 
X 
Difficulty using 
the paretic arm  
Stroke Impact Scale – Hand 
subsection (SIS-H) 
X 
X 
X 
X 

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Procedures to lessen the probability or magnitude of risks: 
 
• Possible risk: Pain and/or Fatigue during stroke rehabilitation therapy.  
o Therapy sessions will be conducted by a licensed occupational therapist. Heart rate 
and blood pressure will be recorded before, during and after each session and the 
study therapist will closely monitor the subject for possible pain or fatigue. Subjects 
will complete pain and fatigue rating scales at the start, middle and end of each 
therapy session.  If pain and/or fatigue ratings exceed minimal (e.g., greater than 4 
on a 0-10 rating scale), the therapy session will be stopped, and the subject provided 
a rest period. If needed, the session will be rescheduled. In previous work we 
demonstrated that the functional tasks practiced in a session were at a difficulty level 
that matched or slightly exceeded the subjects’ movement ability level,59 therefore 
we do not expect that the patient will show movement compensations (movement 
compensations are known to cause pain and fatigue). To further assure that 
movement compensations do not emerge and cause pain or fatigue, aspects of 
each task such as object weight, speed of performance or surface heights will be 
manipulated by the therapist.  
 
• Possible risk: Embarrassment during the online learning course 
o Subjects enrolled in this study will participate in an online learning course. Other 
stroke survivors will also be enrolled at the same time. Learning activities will 
include peer-to-peer asynchronous discussions via the forums, and synchronous 
discussions via the WebEx Collaborate virtual classroom. It is possible that a 
subject may feel embarrassed during these discussions. To lessen the probability 
of embarrassment, subjects will be given the option of choosing a username. If 
desired, the username can be one that does not reveal the subjects’ name. In this 
way, he/she can remain anonymous during discussion posts. Also, the “guidelines 
and expectations” for the course (a document posted and reviewed during the first 
week) will clearly specify that a subject has a choice whether to reveal personal 
details during peer-to-peer discussions during virtual classroom sessions. This 
expectation will be repeated before each virtual classroom session.  
 
• Possible risk: Loss of privacy due to the focus groups. A focus group is a discussion 
group and therefore it is possible that a stroke survivor may reveal information about 
him/herself during the discussion. This information may cause embarrassment.  It is also 
possible that a focus group member inadvertently shares information outside the focus 
group.  The focus group leader will remind members of this possible risk, that 
participation is voluntary, and to respect each other’s privacy.  
 
Source Records:  All data about subjects will be collected from the subjects themselves. No 
other medical records will be accessed in this study.  
 
Data Collection Procedures:  Subjects will be assessed by trained evaluators who will be 
members of the study team.  The following constructs will be measured by the following 
methods:  
• Short Assessment of Health Literacy is an 18-item test designed to assess an adult’s 
ability to read and understand common medical terms. It will be administered by the 

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study therapist in a standardized manner.  Subjects’ receive 1 point for each correct item. 
A score below 14/18 indicates poor health literacy.   
 
• Technology Literacy self-evaluation is a 23-item questionnaire in which the subject 
answers true/false to questions about his/her readiness to participate in an online course.  
Any items in which the subject answers “false” will be reviewed with the subject by the 
study team in efforts to remedy the lack of technological confidence or literacy.  
 
• Participants’ Experiences and Participants’ Self-Management Skills: Participants’ 
viewpoints on the course will be assessed qualitatively using focus groups. A focus group 
guide will structure these sessions. The focus groups will be led by the co-I, Dr. Michelle 
Nichols who is an experience focus group leader and has the necessary expertise for 
qualitative data analyses.  
 
• Self-Efficacy will be assessed using the NIH PROMIS Self-Efficacy for Managing Daily 
Activities assessment. This is an 8-item assessment where a participant reports his/her 
level of confidence in doing 8 daily activities such as performing household chores, 
lift/carry groceries and shop/run errands.  
 
• Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. 
This is an 8-item patient self-report assessment indicating patients’ frequency (never, 
rarely, sometimes, usually, always) having feelings such as being left out, detached, 
isolated etc.  
 
• Emotional Support will be assessed using the NIH PROMIS Emotional Support 
assessment. This 8-item assessment records patient’s self-reported view of the 
frequency (never, rarely, sometimes, usually, always) with which he/she has emotional 
support from others in areas such as listening, someone to confide it, someone who 
understands one’s problems etc.  
 
• Arm movement impairment will be measured with the Fug-Meyer Assessment of the 
Upper Extremity, a 30-item assessment that indicates how well a stroke survivor is able 
to move his/her paretic arm into/out of various postures. Each assessment item is scored 
on a 3 point ordinal scale (0=unable, 1=partial ability, 2=near normal ability), and the item 
ratings are totaled and reported out of 60 points so that higher scores indicate less 
impairment (i.e., more ability).  
 
• Arm motor function will be measured with the Wolf Motor Function Test (WMFT), a 15-
item assessment indicating the speed at which a stroke survivor can move the paretic 
arm to complete functional tasks such as stacking checkers or picking up a soda can. 
Each assessment item is timed, and the average time per item is reported in seconds so 
that lower scores indicate greater functional ability.  
 
• Paretic arm use in the home will be measured with wrist worn accelerometers.  Subjects 
will be issued 2 accelerometers which are worn on each wrist for 48 hrs. They are the 
size of an Apple Watch. Subjects will either bring the devices back to the research center 
at their next visit or mail them back in mailers that we will provide (we pay postage). 3-D 
acceleration data will be downloaded and used to calculate variables that indicate the 
acceleration of the paretic arm relative to the non-paretic arm. A neurologically healthy 

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individual will have values close to 1 to indicate bimanual arm use, smaller numbers 
indicate less use of the paretic arm, i.e., over-reliance on the non-paretic arm.  
 
• Difficulty using the paretic arm during daily activities will be assessed with the Stroke 
Impact Scale – Hand subtest. This is a 5-item assessment in which the patient reports 
the amount of difficulty using the paretic hand along an ordinal scale (0=no difficulty, 
5=great difficulty). 
 
 
 
11.0 Specimen Collection and Banking (if applicable) 
 
N/A.  No specimens will be collected or banked.  
 
12.0 Data Management  
 
Data Analysis: Feasibility will be described. Early indication of efficacy will be described by 
plotting repeated measures of the secondary outcomes at each assessment timepoint to indicate 
the longitudinal impact of the interventions on paretic arm impairment and function.  
 
Sample Size: The primary outcome measure is feasibility.  One aspect of feasibility will be 
subjects’ “engagement” in the program which  will be defined as a point estimate35 by creating a 
nominal variable to describe subjects’ engagement level: “Engaged” defined as completing ≥80% 
of the in-clinic/online activities, “Less Engaged” as completing <80% of the activities.  This project 
is a step towards a full roll out of this program in which estimating engagement is critical for both 
future sample size estimates and understanding/planning for the possible pitfalls of a subsequent 
implementation trial. We anticipate that 5% or fewer will demonstrate non-engagement based on 
previous low attrition rates in our RCTs. A point estimate calculation yielded N=12 to give us 95% 
confidence that ~90% of a sample should be “engaged” in the TEAACH course if the true rate of 
engagement is 3%.  
 
Data Security and Confidentiality:  The IRB-approved study team will be the only people with 
access to PHI.  All hard-copy PHI (e.g., signed ICFs) will be stored in a locked cabinet in a locked 
office in the PIs research laboratory office space on the 2nd floor of CHP-C. All e-copy PHI (e.g., 
enrollment logs) will be stored on the MUSC network in the PI’s dedicated network space which 
is behind the MUSC firewall with MUSC approved security.  All files will be password protected 
and accessible only to the study team with the correct passwords. All subjects will be assigned a 
study specific code that will not relate to any of his/her PHI. This code will be used on all CRFs. 
No PHI will appear on CRFs. The link between PHI and the subject ID code will be separated 
from data during storage and data use.  
 
Quality Control of Collected Data: One study team member will be assigned the task of routinely 
reviewing data entry to assure its completeness.  In addition, all data will be entered into a study 
specific Redcap dataset which will be designed to provide alerts if the data are missing or entered 
incorrectly.  
 
No data will leave MUSC.  

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13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects (if applicable) 
 
Overall framework for monitoring: Participant safety will be monitored by the research 
therapist and PI who are licensed, registered occupational therapists as well as the study co-I 
who is an experience stroke rehabilitation nurse.  The risks of this study include subject fatigue. 
Pain, embarrassment, and loss of privacy.  
 
Frequency of monitoring: Therapy sessions will be conducted by a licensed occupational 
therapist. Heart rate and blood pressure will be recorded before, during and after each session 
and the study therapist will closely monitor the subject for possible pain or fatigue by having 
subjects complete a self-reported summary of pain and fatigue using a Borg rating scale. In 
previous work we demonstrated that the functional tasks practiced in a session were at a 
difficulty level that matched or slightly exceeded the subjects’ movement ability level, therefore 
we do not expect that the patient will show movement compensations. To further assure that 
movement compensations do not emerge and cause pain or injury, aspects of each task such 
as object weight, speed of performance or surface heights will be manipulated by the therapist. 
 
Process for reporting adverse events: The PI, Co-I, research therapist and/or project 
coordinator will be responsible for reporting adverse events as per the policies and procedures 
of the MUSC Institutional Review Board.  
 
Trial monitoring: the PI and co-I will be responsible for trial monitoring and assure that the trial 
is conducted according to the approved protocol. Because this trial is low risk, i.e., no greater 
risk than a traditional outpatient occupational therapy rehabilitation program, the PI and co-PI 
are appropriate monitors. The study team will meet at a minimum each week to identify and 
address any safety issues but can meet immediately if an urgent issue arises. In addition, the 
building in which this study will take place has offices for several of the MUSC COBRE in Stroke 
Recovery investigators who are experienced stroke MDs. As needed, an MD can immediately 
be consulted.  
 
14.0 Withdrawal of Subjects (if applicable) 
Subject Voluntary 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, hospitalization), 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. 
 
15.0 Risks to Subjects 
The risks to the subjects are related to the therapy intervention are no greater than an 
outpatient stroke rehabilitation program. These risks include fatigue and pain. 

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• Fatigue:  Although most of the upper extremity rehabilitation activities will occur 
while the subject is seated, it is possible that subjects become fatigued as a result 
of participating the therapy intervention.  In our past studies (including an RCT with 
n=103 stroke survivors) using the same or similar therapy protocol, subjects 
routinely reported fatigue during and immediately following the therapy session.  
However, the level of fatigue was rated as an average of 3-5/10 on a self-report 
Likert scale.  This was considered low to moderate fatigue, and in no case limited 
subjects’ ability to carry on with their day.  If subjects in the present study report 
fatigue during therapy,  
• Pain:  In our past stroke rehabilitation RCT (n=103) ~60% of subjects reported 
some level of pain in the paretic arm. In 10% of those cases (n=11), the pain was 
severe enough that the therapist recommended that the see a primary care 
physician. In most of cases, the therapist adjusted the intensity of therapy to 
reduce pain level (e.g., reduced the height of the tasks practiced, provided 
assistance).  
• Loss of confidentiality due to e-learning course participation: it is possible 
that participating in the online course will cause subjects to lose confidentiality 
because others in the course will know their name.  To mitigate this risk, we will 
offer subjects opportunity to choose their own username when logging into the 
course. This will enable them to remain anonymous.  
• Embarrassment: It is also possible that subjects will be embarrassed by the e-
learning course because lessons or assignments may showcase a weak area 
(e.g., something the subject has difficulty doing).   Subjects will be informed that 
they can “opt out” of any assignment or discussion as they wish.  Also, subjects 
will be shown how to delete a post in the e-learning course forum and discussion 
boards in case they have second thoughts about something they wrote.  
• Loss of privacy due to focus group discussions. It is possible that a focus 
group member may share information about another focus group member outside 
of the group. The study team will remind focus group members that participation is 
voluntary and to respect each other’s privacy.   
• Loss of confidentiality due to breach of data: 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 subject’s 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 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 
We expect that subjects will improve their own skills for managing their stroke.  For 
example, we anticipate that subjects will know more about stroke, stroke recovery, and 
develop skills that promote increased use of the paretic arm in the home and community 
environments.  However, it is possible that subjects do not have any direct benefit. 

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Although the subjects may not benefit individually, we will understand more about the 
feasibility of providing online education to this patient population.  
 
 
17.0 Sharing of Results with Subjects 
The study will be registered as a clinical trial at clinicaltrials.gov.  All data will be shared 
as per clinicaltrials.gov requirements.  In addition, each subject can request a copy of 
his/her own data at any time during the study.  
 
18.0 Drugs or Devices (if applicable)  
 
N/A.  There are no drugs or devices studied. 
 
 
 
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