N/A
N=48
Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format
Stroke · Hemiparesis
Bottom Line
View on ClinicalTrials.gov: NCT02665052 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Wolf Motor Function Test Performance Time (WMFT) — 3.6; 2.9; 3.1 log (seconds) — p=0.64
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-Based BATRAC plus TTT (Device); Lab-based BATRAC plus TTT (Device); Delayed Entry Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wolf Motor Function Test Performance Time (WMFT) |
3.6; 2.9; 3.1 | 0.64 |
| SECONDARY Fugl-Meyer Assessment Scale-Upper Extremity |
32.3; 40.7; 32.0 | 0.01 sig |
| SECONDARY Stroke Impact Scale (SIS)-Hand Domain |
31.9; 45.0; 39.4 | 0.31 |
Summary
Loss of arm use and strength are common problems after stroke that greatly affects independence in activities of daily living. Arm rehabilitation using robot-assisted repetitive task training has shown to improve motor recovery. However, this type of exercise cannot be done at home as these devices are large and expensive. This study will test whether a more portable, less costly, non-robotic repetitive training device called Bilateral Arm Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation format will lead to improvement in arm and hand use in patients with chronic stroke. The investigators plan to test the effectiveness of home based tele-rehabilitation with the BATRAC compared to a home and a clinic based approach.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Have a clinically defined unilateral hemiparetic stroke with radiologic exclusion of other diagnosis
- Stroke onset of at least 6 months prior to enrollment
- Present with moderate to severe arm impairment based on a Fugl-Meyer score ranging from 19-50 out of 66
- No previous experience using the BATRAC
- Ability to use and interact with the tele-rehabilitation platform according to study protocol
- Have an identified individual/caregiver to perform the TTT exercises if randomized to the Home Telerehabilitation group
Exclusion Criteria
- Musculoskeletal diagnosis or significant arm pain that would interfere with positioning and use of the intervention (BATRAC) devices
- Cognitive impairment such that the participant is unable to understand the study requirements to answer the Evaluation to Sign Consent Form tool accurately
- Absence of a working telephone line or cell phone for telerehabilitation set-up if randomized to this group
- Enrollment in a concurrent rehabilitation study or actively receiving therapy for their stroke affected (study) arm
- Having received a botulinum toxin injection to the stroke affected (study) arm within 3 months of enrollment
Data sourced from ClinicalTrials.gov (NCT02665052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.