Bilateral Movement Training for People With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247674
• Other study ID #: NYMU20140829
• Status: Completed
• Phase: N/A
• First received: August 31, 2014
• Last updated: September 19, 2014
• Start date: November 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 81 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injury
• Cardiovascular Disease
• Cardiovascular Diseases
• Cerebrovascular Accident
• Stroke

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chueh-Ho Lin	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)	Outcome measure was assessed before and after 4 weeks intervention.	before and after 4 weeks intervention	No
Secondary	Barthel Index (BI)	Outcome measure was assessed before and after 4 weeks intervention.	before and after 4 weeks intervention	No
Secondary	Motor Assessment Score (MAS)	Outcome measure was assessed before and after 4 weeks intervention.	before and after 4 weeks intervention	No
Secondary	Wolf Motor Function Test (WMFT)	Outcome measure was assessed before and after 4 weeks intervention.	before and after 4 weeks intervention	No