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Bilateral Movement Training for People With Stroke

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ClinicalTrials.gov Identifier: NCT02247674
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
Chueh-Ho Lin, National Yang Ming University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident Cardiovascular Disease Brain Injury Procedure: Bilateral movement training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : October 2013

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 Name: 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 Name: Coupling movement




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Barthel Index (BI) [ Time Frame: before and after 4 weeks intervention ]
    Outcome measure was assessed before and after 4 weeks intervention.

  2. Motor Assessment Score (MAS) [ Time Frame: before and after 4 weeks intervention ]
    Outcome measure was assessed before and after 4 weeks intervention.

  3. Wolf Motor Function Test (WMFT) [ Time Frame: before and after 4 weeks intervention ]
    Outcome measure was assessed before and after 4 weeks intervention.



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Ages Eligible for Study:   28 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247674


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Chueh-Ho Lin
National Yang Ming University
Investigators
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Study Chair: Wen-Hsu Sung, PhD Department of Physical Therapy and Assistive Technology, National Yang-Ming University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chueh-Ho Lin, Dr., National Yang Ming University
ClinicalTrials.gov Identifier: NCT02247674     History of Changes
Other Study ID Numbers: NYMU20140829
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Chueh-Ho Lin, National Yang Ming University:
Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
Additional relevant MeSH terms:
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Stroke
Brain Injuries
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries