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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-AutoCITE
CI therapy
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, chronic, arm, rehabilitation, tele-health

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CI therapy

Tele-AutoCITE

Arm Description

AutoCITE stands for Automated Constraint Induced Therapy Extender.

Outcomes

Primary Outcome Measures

Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
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
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
See primary outcome.
Change in MAL Arm Use Scale at 12 months
See primary outcome.

Full Information

First Posted
June 17, 2010
Last Updated
September 26, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01157195
Brief Title
Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Official Title
Home-Based Automated Therapy of Arm Function After Stroke Via Tele-Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, chronic, arm, rehabilitation, tele-health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CI therapy
Arm Type
Active Comparator
Arm Title
Tele-AutoCITE
Arm Type
Experimental
Arm Description
AutoCITE stands for Automated Constraint Induced Therapy Extender.
Intervention Type
Behavioral
Intervention Name(s)
Tele-AutoCITE
Intervention Description
Automated, remotely-administered form of CI therapy
Intervention Type
Behavioral
Intervention Name(s)
CI therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Motor Activity Log (MAL) Arm Use Scale at 2 weeks
Description
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.
Time Frame
Baseline to 2 weeks (average)
Secondary Outcome Measure Information:
Title
Change in Wolf Motor Function Test (WMFT) Performance Rate at 2 weeks
Description
Well-validated laboratory motor performance test that assesses how quickly an individual can perform upper-extremity tasks with the more-affected arm after stroke.
Time Frame
Baseline to 2 weeks (average)
Title
Change in MAL Arm Use Scale at 6 months
Description
See primary outcome.
Time Frame
Baseline to 6 months (average)
Title
Change in MAL Arm Use Scale at 12 months
Description
See primary outcome.
Time Frame
Baseline to 12 months (average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitendra Uswatte, PhD
Organizational Affiliation
Psychology Department, University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10659807
Citation
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.
Results Reference
background

Learn more about this trial

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

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