Bilateral Movement Training for People With Stroke

• Sponsor: Chueh-Ho Lin (Other)
• Overall Status: Completed
• CT.gov ID: NCT02247674
• Collaborator: National Yang Ming University (Other)
• Enrollment: 33
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 3

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE) [before and after 4 weeks intervention]

   Outcome measure was assessed before and after 4 weeks intervention.

Secondary Outcome Measures

1. Barthel Index (BI) [before and after 4 weeks intervention]

   Outcome measure was assessed before and after 4 weeks intervention.

2. Motor Assessment Score (MAS) [before and after 4 weeks intervention]

   Outcome measure was assessed before and after 4 weeks intervention.

3. Wolf Motor Function Test (WMFT) [before and after 4 weeks intervention]

   Outcome measure was assessed before and after 4 weeks intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 28 Years to 81 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	112

Sponsors and Collaborators

• Chueh-Ho Lin
• National Yang Ming University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chueh-Ho Lin, Dr., National Yang Ming University
• ClinicalTrials.gov Identifier: NCT02247674
• Other Study ID Numbers: NYMU20140829
• First Posted: Sep 25, 2014
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Chueh-Ho Lin, Dr., National Yang Ming University: Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
• Additional relevant MeSH terms: Stroke; Brain Injuries; Cardiovascular Diseases

Study Results

No Results Posted as of Sep 25, 2014