CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Home-Based BATRAC plus TTT +2 moredevice
Likely dose
60 minutes of training per session (45 minutes BATRAC plus 15 minutes transition-to-task training)AI-extracted
Key inclusion· 7
  • Age 18 years or older
  • Clinically defined unilateral hemiparetic stroke with radiologic exclusion of other diagnoses
  • Stroke onset ≥6 months prior to enrollment
  • Moderate to severe arm impairment: Fugl-Meyer score 19–50 out of 66
Key exclusion· 5
  • Musculoskeletal diagnosis or significant arm pain that would interfere with positioning and use of BATRAC devices
  • Cognitive impairment such that participant is unable to understand study requirements and answer the Evaluation to Sign Consent Form tool accurately
  • Absence of working telephone line or cell phone for telerehabilitation setup if randomized to home group
  • Enrollment in concurrent rehabilitation study or actively receiving therapy for stroke-affected arm

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02665052
NCT02665052N/ACompleted

Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format

VA Office of Research and Development·interventional·Posted Jan 27, 2016·Updated Mar 17, 2021

In Brief

A clinical study evaluating Home-Based BATRAC plus TTT, Lab-based BATRAC plus TTT, and 1 other intervention for Stroke and Hemiparesis. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Hemiparesis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 27, 2016
Enrollment StartMay 1, 2017
Primary CompletionJan 16, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 10.4 years ago

Interventions

Home-Based BATRAC plus TTTdevice

Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.

Lab-based BATRAC plus TTTdevice

Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist.

Delayed Entry Usual Carebehavioral

Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level.