Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke
2 other identifiers
interventional
42
1 country
1
Brief Summary
This proposed project aims to
- compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with bilateral upper limb rehabilitation based on task-related practice
- compare the effects of unilateral vs bilateral training based on robot-assisted devices
- study the predictors of treatment outcomes and clinimetric properties of the biomechanical measures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 30, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 8, 2015
June 1, 2015
4.2 years
January 30, 2012
June 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Movement time
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. MT is the interval between movement onset and offset.
Baseline and change from baseline in movement time at 4 weeks
Motor units
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. One MU consists of 1 acceleration and 1 deceleration phase of reaching and can be used to characterize movement smoothness.
Baseline and change from baseline in motor units at 4 weeks
Elbow extension angle
The movement time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. The angular degree of elbow extension will be calculated by subtracting the angle at the start of the movement from the angle at the end of the movement
Baseline and change from baseline in elbow extension angle at 4 weeks
Lateral index
The fMRI will be performed on a 3T Magnetom Vision MRI scanner (Siemens, Erlangen, Germany) before and after intervention. The change of Blood oxygenation level-dependent (BOLD) functional images in regions-of-interest will be collected. The laterality index (LI) will be calculated to provide an estimation of the relative hemispheric activation.
Baseline and change from baseline in lateral index at 4 weeks
Secondary Outcomes (10)
Test of center of pressure (CoP) displacement
Baseline and change from baseline in test of CoP displacement at 4 weeks
Hand strength
Baseline and change from baseline in hand strength at 4 weeks
Electromyography (EMG)
Baseline and change from baseline in EMG at 4 weeks
Modified Ashworth Scale (MAS)
Baseline, change from baseline in MAS at 2 weeks, and change from baseline in muscle tone at 4 weeks
Fugl-Meyer Assessment (FMA)
Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks
- +5 more secondary outcomes
Study Arms (5)
Task-Related UAT
EXPERIMENTALTherapist conducted unilateral arm training Task-related unilateral arm training
Task-Related BAT
EXPERIMENTALTherapist conducted bilateral arm Training Task-related bilateral arm training
Task-Related UAT coupling BAT
EXPERIMENTALTherapist conducted task-related unilateral training for 45 minutes, followed by task-related bilateral arm training for another 45 minutes during each training session
Robot-assisted UAT
EXPERIMENTALRobot-assisted unilateral arm training
Robot-assisted BAT
EXPERIMENTALRobot-assisted bilateral arm training
Interventions
The training tasks will involve daily activities with unilateral proximal or distal upper extremity movements for 5 days/week for 1.5 hours/day for 4 consecutive weeks.
This intervention emphasizes UE movements (gross or fine motor tasks) involved in daily activities but focus on both UEs moving synchronously. The duration and intensity of treatment will also be 5 days/week for 1.5 hours/day for 4 consecutive weeks.
The Bi-Manu-Track used in this project (Reha-Stim Co., Berlin, Germany) enables the symmetric practice of 2 movement patterns: forearm pronation-supination and wrist flexion-extension. Each movement has 3 computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed, range of motion, and resistance individually adjustable; (2) active-passive, with the unaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance.
The robot-assisted unilateral arm training group will use mode 1 and 3: (1) passive, affected arm being moved by the machine with speed and range of motion individually adjustable; and (2) active, with the affected arm actively moving. This training program will add an additional mode: active-resistance, with the affected arm/wrist actively moving against resistance.
Eligibility Criteria
You may qualify if:
- to 75 years old
- to 24 months after stroke onset from a first-ever unilateral stroke
- An initial 26 to 56 scores on the UE subsection of the
- Premorbid right-hand dominance evaluated by the Edinburgh Handedness Inventory
- No excessive spasticity in the shoulder and elbow joints of the affected UE (Modified Ashworth Scale score ≤ 3 in each joint)
- Sufficient cognitive ability, defined as a score of more than 24 on the Mini Mental State Examination
You may not qualify if:
- Physician-determined major medical problems or poor physical condition that would interfere with participation
- Excessive pain in any joint that might limit participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Related Publications (1)
Wu CY, Yang CL, Chuang LL, Lin KC, Chen HC, Chen MD, Huang WC. Effect of therapist-based versus robot-assisted bilateral arm training on motor control, functional performance, and quality of life after chronic stroke: a clinical trial. Phys Ther. 2012 Aug;92(8):1006-16. doi: 10.2522/ptj.20110282. Epub 2012 Apr 19.
PMID: 22517782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching-yi Wu, ScD
Chang Gung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2012
First Posted
February 3, 2012
Study Start
January 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 8, 2015
Record last verified: 2015-06