Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke
NCT ID: NCT01525979
Last Updated: 2015-06-08
Study Results
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Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2011-01-31
2015-04-30
Brief Summary
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* 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
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Detailed Description
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The long-term objective is to conduct comparative efficacy research to identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches of fully defined-, evidence-based, and theory-grounded approaches. This proposed project aims to (1) compare the effects of dose-matched unilateral vs bilateral vs unilateral combined with bilateral upper limb rehabilitation based on task-related practice; (2) compare the effects of unilateral vs bilateral training based on robot-assisted devices; and (3) study the predictors of treatment outcomes and clinimetric properties of the biomechanical measures. The outcome measures will span the spectrum of health-related functioning, including motor and neural control, movement performance, daily functions, and quality of life. Motor and neural control mechanisms involving movement strategies, muscle and force output, and brain reorganization will be evaluated using kinematic, electromyographic (EMG), and kinetic analyses, and also functional magnetic resonance imaging (fMRI) examinations. Clinical outcomes will include movement performance, daily functions, and quality of life, measured by MYOTON-3, Modified Ashworth Scale, the Fugl-Meyer Assessment, Wolf Motor Function Test, Functional Independence Measure, ABILHAND questionnaire, accelerometers, and Stroke Impact Scale. This 5-year project will recruit an estimated 200 patients with stroke. For Part 1, 120 patients with mild-to-moderate motor impairment will be randomized to the dose-matched unilateral, bilateral, or combined group. For Part 1, 80 stroke patients with moderate motor impairment will be randomized to the dose-matched unilateral or bilateral robot-assisted therapy group. Treatment regimens will be designed to ensure that patients in the 3 groups in Part 1 and 2 groups in Part 2 receive an equivalent intensity of treatment (5 days/week for 1.5 hours/day for 4 consecutive weeks). The intervention will be provided at 4 hospitals. Two certified occupational therapists will be trained in the administration of the 5 types of rehabilitation protocols by the PI and a co-PI and will complete a written competency test before subject treatment.
Biomechanical (kinematic, EMG, and kinetic) and fMRI examinations will be performed before, immediately after the 4-week intervention period, and at the 3-month follow-up period (no fMRI examination at follow-up). Clinical measures will be administered before, at midterm (2 weeks after intervention), immediately after, and 3 months after the intervention. At least 3 examiners (1 research assistant, 1 graduate student, and 1 post-doc fellow) blind to group allocation will be in charge of biomechanical, fMRI, and clinical measures. Each type of measure will require 2 evaluators to collaborate for completing the assessment. Before being allowed to work with participants, the examiner's competence will be assessed by the PI and co-PI, and interrater reliability for clinical tests established.
Multivariate analysis of covariance will be used to examine changes in all outcome measures as a function of treatment while controlling for baseline data. Multiple regression models will be established to determine the potential predictors for different functional outcomes of each intervention (unilateral and bilateral training approach). The responsiveness and validity of the biomechanical measures relevant for clinimetric scrutiny will be examined by the index of standardized response mean and Spearman correlation coefficients. The clinical important differences of the biomechanical parameters will be determined by the anchor-based and the distribution-based clinical important differences estimate.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Task-Related UAT
Therapist conducted unilateral arm training Task-related unilateral arm training
Task-related unilateral arm training
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.
Task-Related BAT
Therapist conducted bilateral arm Training Task-related bilateral arm training
Task-related bilateral arm training
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.
Task-Related UAT coupling BAT
Therapist conducted task-related unilateral training for 45 minutes, followed by task-related bilateral arm training for another 45 minutes during each training session
Task-related unilateral arm training
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.
Task-related bilateral arm training
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.
Robot-assisted UAT
Robot-assisted unilateral arm training
Robot-assisted unilateral arm training
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.
Robot-assisted BAT
Robot-assisted bilateral arm training
Robot-assisted bilateral arm training
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.
Interventions
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Task-related unilateral arm training
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.
Task-related bilateral arm training
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.
Robot-assisted bilateral arm training
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.
Robot-assisted unilateral arm training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 6 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
Exclusion Criteria
* Excessive pain in any joint that might limit participation
40 Years
75 Years
ALL
No
Sponsors
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National Science and Technology Council, Taiwan
OTHER_GOV
National Health Research Institutes, Taiwan
OTHER
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Ching-yi Wu, ScD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung University
Locations
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Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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References
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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.
Other Identifiers
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NHRI-EX100-10010PI
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
99-0832B
Identifier Type: -
Identifier Source: org_study_id
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