Bilateral Movement Training for People With Stroke

September 19, 2014 updated by: Chueh-Ho Lin

Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke

The investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To investigate the training effects of interlimb force coupling training on paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the relationship between motor recovery of paretic hand, arm and functional abilities.

Design: A double-blind randomized controlled trial with outcome assessment at baseline and after 4 weeks intervention.

Setting: Department of physical medicine and rehabilitation in Taipei Veterans General Hospital.

Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were recruited and randomized assigned to training (n=16) and control group (n=17).

Interventions: Interlimb force coupling training task included different gripforce generation on the both hands.

Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function Test (WMFT). All assessment was executed by a blinded evaluator, and data management and statistical analysis was also conducted by a blinded statistic researcher.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. at least 6 months since stroke
  2. three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
  3. ability to flex and extend the paretic arm and hand
  4. Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
  5. Mini-Mental State Examination (MMSE) score should 24 or higher
  6. no other orthopedic neurological disorders
  7. Brunnstrom stage 3 or 4
  8. no joint in other experimental rehabilitation or drug studies 21

Exclusion Criteria:

  1. unstable cardiovascular conditions
  2. uncontrolled hypertension (190/110 mm Hg)
  3. severe orthopedic or pain conditions
  4. dementia (Mini-Mental State Examination score < 22)
  5. aphasia with inability to follow researcher's commands
  6. severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Education & training consultation
Education and training consultations were provided for subjects in control group during study period.
Procedure: Bilateral movement training
Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
Other Names:
  • Coupling movement
Experimental: Bilateral movement training
Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
Procedure: Bilateral movement training
Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
Other Names:
  • Coupling movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
Time Frame: before and after 4 weeks intervention
Outcome measure was assessed before and after 4 weeks intervention.
before and after 4 weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index (BI)
Time Frame: before and after 4 weeks intervention
Outcome measure was assessed before and after 4 weeks intervention.
before and after 4 weeks intervention
Motor Assessment Score (MAS)
Time Frame: before and after 4 weeks intervention
Outcome measure was assessed before and after 4 weeks intervention.
before and after 4 weeks intervention
Wolf Motor Function Test (WMFT)
Time Frame: before and after 4 weeks intervention
Outcome measure was assessed before and after 4 weeks intervention.
before and after 4 weeks intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chueh-Ho Lin

Collaborators

National Yang Ming University

Investigators

  • Study Chair: Wen-Hsu Sung, PhD, Department of Physical Therapy and Assistive Technology, National Yang-Ming University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 31, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYMU20140829

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Bilateral movement training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe