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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gitendra Uswatte, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01157195
First received: June 17, 2010
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Stroke
Behavioral: Tele-AutoCITE
Behavioral: CI therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks [ Time Frame: Baseline to 2 weeks (average) ] [ Designated as safety issue: No ]
    Well-validated structured interview that assesses how much and how well the more-affected arm after stroke has been used to accomplish everyday activities over a specified period.


Secondary Outcome Measures:
  • Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks [ Time Frame: Baseline to 2 weeks (average) ] [ Designated as safety issue: No ]
    Well-validated laboratory motor performance test that assesses how quickly an individual can perform upper-extremity tasks with the more-affected arm after stroke.

  • Change in MAL Arm Use Scale at 6 months [ Time Frame: Baseline to 6 months (average) ] [ Designated as safety issue: No ]
    See primary outcome.

  • Change in MAL Arm Use Scale at 12 months [ Time Frame: Baseline to 12 months (average) ] [ Designated as safety issue: No ]
    See primary outcome.


Enrollment: 25
Study Start Date: June 2010
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CI therapy Behavioral: CI therapy
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.
Experimental: Tele-AutoCITE
AutoCITE stands for Automated Constraint Induced Therapy Extender.
Behavioral: Tele-AutoCITE
Automated, remotely-administered form of CI therapy

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • more than 1 year after stroke
  • some ability to voluntarily open fingers on more affected side of body
  • some ability to voluntarily raise wrist on more affected side of body
  • ability to stand independently for two minutes
  • ability to transfer from sit to stand independently

Exclusion Criteria:

  • serious, concurrent medical conditions including frailty
  • excessive spasticity (high muscle tone) in more affected arm
  • impairment in thinking that makes compliance with study activities difficult
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157195

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Gitendra Uswatte, PhD Psychology Department, University of Alabama at Birmingham
  More Information

Publications:
Responsible Party: Gitendra Uswatte, Associate Professor of Psychology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01157195     History of Changes
Other Study ID Numbers: F071227003, R01HD053750
Study First Received: June 17, 2010
Last Updated: December 4, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
stroke
chronic
arm
rehabilitation
tele-health

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 26, 2014