E-learning+ Rehab Therapy

NCT04245449 | Terminated Results

• 2 other identifiers: 00081749P20GM109040-06
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Self-Efficacy for Managing Daily Activities From Baseline to 3 Months and 5 Months

  Baseline Visit, 3 months and 5 months

• Change in Social Isolation From Baseline to 3 Months and 5 Months

  Baseline Visit, 3 months & 5 months

• Change in Emotional Support From Baseline to 3 Months and 5 Months

  Baseline Visit, 3 months (Post Treatment+/- 3 days), & 5 months (Follow up +/- 3 days)

Study Arms (1)

e learning+therapy (TEAACH)

EXPERIMENTAL

TEAACH-Training to Empower Activity-dependent plasticity-based Arm-use habits in the Community and at Home

Behavioral: TEAACH

Interventions

TEAACH BEHAVIORAL

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.

e learning+therapy (TEAACH)

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• wi-fi connection in the home and either a computer, smartphone or tablet.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Michelle Woodbury, PhD
• Organization: Medical University of South Carolina

woodbuml@musc.edu

843-792-0651

Study Officials

• Michelle Woodbury, PT, PhD

  Medical University of SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 29, 2020
• Study Start: August 8, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 17, 2023
• Results First Posted: January 26, 2023

Record last verified: 2023-03

Locations

US (1)