E-learning+ Rehab Therapy

Stroke Clinical Trial

— TEAACH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04245449
• Other study ID #: 00081749
• Secondary ID: P20GM109040-06
• Status: Terminated
• Phase: N/A
• Start date: August 8, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• TEAACH
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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)