E-learning+ Rehab Therapy

Study Overview
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Brief Summary
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Stroke survivors with arm paresis because of stroke use their good arm for daily activities, but in doing so may be self-limiting their own recovery of the bad arm. Traditional models of stroke rehabilitation fail to fully engage the survivor and care partner(s) in actively planning post-discharge habits that improve their capacity to live well over their entire lives. This study will test a cutting-edge in-person therapy + online training program designed to progressively transfer the responsibility of driving post-stroke recovery from the therapist to the survivor.

Official Title
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A Novel Therapy + E-learning Self-management Program for Stroke Survivors

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: TEAACH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: paresis of one arm/hand because of ischemic or hemorrhagic stroke >2 mo. and <3 yrs prior moderate arm impairment defined as a baseline Fugl-Meyer Assessment of the Upper Extremity score of at least 32±2 points but no more than 47±2 points (out of 60 points) Montreal Cognitive Assessment score ≥22 ability to read English ability to communicate as per the therapists' judgement at baseline testing 21-90 years of age wi-fi connection in the home and either a computer, smartphone or tablet. Exclusion criteria: lesion or injury to brainstem or cerebellum other neurological disease that may impair motor or learning skills (e.g., Parkinson's Disease); pain interfering with reaching uncorrected vision making it difficult to read information on a computer, tablet or phone.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: e learning+therapy (TEAACH)<br>TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home | Behavioral: TEAACH<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health Literacy From Baseline to 3 Months | Health Literacy will be assessed via a standardize 18-item test designed to assess an adult's ability to read and understand common medical terms. Minimum = 0, Maximum = 18. Higher scores indicate greater health literacy. | Baseline Visit and 3 months | 
| Change in Self Management Skills From Baseline to 3 Months | Participants' ability to manage their chronic condition (their stroke) will be assessed qualitatively using interview questions. Participants' narratives will be analyzed and reported as a description of how their own skills have changed. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months | Self-Efficacy will be assessed using the NIH PROMIS Self-Efficacy for Managing Daily Activities assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater self efficacy. | Baseline Visit, 3 months and 5 months | 
| Change in Social Isolation From Baseline to 3 Months and 5 Months | Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation. | Baseline Visit, 3 months & 5 months | 
| Change in Emotional Support From Baseline to 3 Months and 5 Months | Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support. | Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days) |