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

June 17, 2010
December 4, 2013
June 2010
August 2013   (final data collection date for primary outcome measure)
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.
Motor Activity Log (MAL) Arm Use Scale [ Time Frame: 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.
Complete list of historical versions of study NCT01157195 on ClinicalTrials.gov Archive Site
  • 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.
  • Wolf Motor Function Test (WMFT) Performance Time [ Time Frame: 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.
  • MAL Arm Use Scale [ Time Frame: 6 months and 1 year (average) ] [ Designated as safety issue: No ]
    See primary outcome.
Not Provided
Not Provided
 
Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
  • Behavioral: Tele-AutoCITE
    Automated, remotely-administered form of 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.
  • Active Comparator: CI therapy
    Intervention: Behavioral: CI therapy
  • Experimental: Tele-AutoCITE
    AutoCITE stands for Automated Constraint Induced Therapy Extender.
    Intervention: Behavioral: Tele-AutoCITE
Taub E, Uswatte G, Pidikiti R. Constraint-Induced Movement Therapy: a new family of techniques with broad application to physical rehabilitation--a clinical review. J Rehabil Res Dev. 1999 Jul;36(3):237-51. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
August 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01157195
F071227003, R01HD053750
Yes
Gitendra Uswatte, University of Alabama at Birmingham
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Gitendra Uswatte, PhD Psychology Department, University of Alabama at Birmingham
University of Alabama at Birmingham
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP