Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation

Active, not recruiting

Phase N/A Results N/A

Trial Description

Constraint-Induced Movement therapy, also known as CI therapy, is an approach to physical rehabilitation derived from basic behavioral and neuroscience research. It has been shown to be efficacious for rehabilitating use of the more-affected arm in individuals more than one year after stroke with mild to moderate motor impairment. The first component of the therapy is intensive training in use of the more-affected arm on functional tasks for 3 hours daily for 10 consecutive weekdays. The second is wearing a protective safety mitt on the less-affected hand for all waking hours of the approximately 2-week treatment period that it is safe to do so. The purpose of the mitt is to discourage use of the less-affected arm. The third is a group of behavioral techniques designed to transfer gains from the treatment setting to the real world, which takes a therapist, on average, 30 minutes to implement on each treatment day.
The purpose of this project is to develop and test a method for automating the delivery of this efficacious treatment in a way that the therapy can be provided in stroke patients' homes. After developing an automated CI therapy workstation that has tele-health capabilities, the investigators will conduct a randomized controlled trial to evaluate whether CI therapy delivered in the home using this workstation with remote supervision by a therapist via an Internet-based audiovisual link provides outcomes that are just as good as CI therapy delivered by a "live" therapist.

Conditions

Interventions

  • Tele-AutoCITE Behavioral
    Intervention Desc: Automated, remotely-administered form of CI therapy
    ARM 1: Kind: Experimental
    Label: Tele-AutoCITE
    Description: AutoCITE stands for Automated Constraint Induced Therapy Extender.
  • CI therapy Behavioral
    Intervention Desc: CI therapy is a behavioral approach to physical rehabilitation that has three components: 1. intense training of the more affected arm for several hours daily for multiple consecutive days, 2. restraint of the less affected arm during training hours and afterwards during the treatment period, 3. A package of behavioral techniques designed to transfer gains from the treatment setting to daily life. In this trial, CI therapy will be administered for 3 1/2 hours per day for 10 consecutive weekdays.
    ARM 1: Kind: Experimental
    Label: CI therapy

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Bio-equivalence Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor Activity Log (MAL) Arm Use Scale 2 weeks (average) No
Secondary Wolf Motor Function Test (WMFT) Performance Time 2 weeks (average) No
Secondary MAL Arm Use Scale 6 months and 1 year (average) No
Primary Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks Baseline to 2 weeks (average) No
Secondary Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks Baseline to 2 weeks (average) No
Secondary Change in MAL Arm Use Scale at 6 months Baseline to 6 months (average) No
Secondary Change in MAL Arm Use Scale at 12 months Baseline to 12 months (average) No

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