Bilateral Movement Training for People With Stroke
Primary Purpose
Stroke, Cerebrovascular Accident, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Bilateral movement training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
Eligibility Criteria
Inclusion Criteria:
- at least 6 months since stroke
- three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
- ability to flex and extend the paretic arm and hand
- Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
- Mini-Mental State Examination (MMSE) score should 24 or higher
- no other orthopedic neurological disorders
- Brunnstrom stage 3 or 4
- no joint in other experimental rehabilitation or drug studies 21
Exclusion Criteria:
- unstable cardiovascular conditions
- uncontrolled hypertension (190/110 mm Hg)
- severe orthopedic or pain conditions
- dementia (Mini-Mental State Examination score < 22)
- aphasia with inability to follow researcher's commands
- severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities
Sites / Locations
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Education & training consultation
Bilateral movement training
Arm Description
Education and training consultations were provided for subjects in control group during study period.
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)
Outcomes
Primary Outcome Measures
Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
Outcome measure was assessed before and after 4 weeks intervention.
Secondary Outcome Measures
Barthel Index (BI)
Outcome measure was assessed before and after 4 weeks intervention.
Motor Assessment Score (MAS)
Outcome measure was assessed before and after 4 weeks intervention.
Wolf Motor Function Test (WMFT)
Outcome measure was assessed before and after 4 weeks intervention.
Full Information
NCT ID
NCT02247674
First Posted
August 31, 2014
Last Updated
September 19, 2014
Sponsor
Chueh-Ho Lin
Collaborators
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT02247674
Brief Title
Bilateral Movement Training for People With Stroke
Official Title
Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chueh-Ho Lin
Collaborators
National Yang Ming University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, Cardiovascular Disease, Brain Injury
Keywords
Stroke, Cerebrovascular accident, Rehabilitation, Upper extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education & training consultation
Arm Type
Placebo Comparator
Arm Description
Education and training consultations were provided for subjects in control group during study period.
Arm Title
Bilateral movement training
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Bilateral movement training
Other Intervention Name(s)
Coupling movement
Intervention Description
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)
Primary Outcome Measure Information:
Title
Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)
Description
Outcome measure was assessed before and after 4 weeks intervention.
Time Frame
before and after 4 weeks intervention
Secondary Outcome Measure Information:
Title
Barthel Index (BI)
Description
Outcome measure was assessed before and after 4 weeks intervention.
Time Frame
before and after 4 weeks intervention
Title
Motor Assessment Score (MAS)
Description
Outcome measure was assessed before and after 4 weeks intervention.
Time Frame
before and after 4 weeks intervention
Title
Wolf Motor Function Test (WMFT)
Description
Outcome measure was assessed before and after 4 weeks intervention.
Time Frame
before and after 4 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 6 months since stroke
three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
ability to flex and extend the paretic arm and hand
Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
Mini-Mental State Examination (MMSE) score should 24 or higher
no other orthopedic neurological disorders
Brunnstrom stage 3 or 4
no joint in other experimental rehabilitation or drug studies 21
Exclusion Criteria:
unstable cardiovascular conditions
uncontrolled hypertension (190/110 mm Hg)
severe orthopedic or pain conditions
dementia (Mini-Mental State Examination score < 22)
aphasia with inability to follow researcher's commands
severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Hsu Sung, PhD
Organizational Affiliation
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26193492
Citation
Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.
Results Reference
derived
Learn more about this trial
Bilateral Movement Training for People With Stroke
We'll reach out to this number within 24 hrs