Back to resultsE-learning+ Rehab Therapy (TEAACH)
Primary Purpose
Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TEAACH
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
e learning+therapy (TEAACH)
Arm Description
TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04245449
First Posted
January 21, 2020
Last Updated
March 15, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT04245449
Brief Title
E-learning+ Rehab Therapy
Acronym
TEAACH
Official Title
A Novel Therapy + E-learning Self-management Program for Stroke Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 and loss of funding
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
e learning+therapy (TEAACH)
Arm Type
Experimental
Arm Description
TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home
Intervention Type
Behavioral
Intervention Name(s)
TEAACH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Health Literacy From Baseline to 3 Months
Description
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.
Time Frame
Baseline Visit and 3 months
Title
Change in Self Management Skills From Baseline to 3 Months
Description
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.
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months
Description
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.
Time Frame
Baseline Visit, 3 months and 5 months
Title
Change in Social Isolation From Baseline to 3 Months and 5 Months
Description
Social Isolation will be assessed using the NIH PROMIS Social Isolation assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate less social isolation.
Time Frame
Baseline Visit, 3 months & 5 months
Title
Change in Emotional Support From Baseline to 3 Months and 5 Months
Description
Emotional Support will be assessed using the NIH PROMIS Emotional Support assessment. Minimum score = 0, Maximum score = 8. Higher numbers indicate greater emotional support.
Time Frame
Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Woodbury, PT, PhD
Organizational Affiliation
Medical University of SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
E-learning+ Rehab Therapy
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