Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke

Completed

Phase N/A Results N/A

Trial Description

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

Detailed Description

An estimated 30% to 66 % of stroke victims have poor upper extremity function at 6 months after stroke, which contributes to long-term disability in these patients. Training the affected UE of stroke patients has thus been a mainstay of neurorehabilitation. The goal of the intervention is to restore motor and daily functions. New therapeutic strategies have been developed based on principles of neurorehabilitation and motor learning. The need for comparative effectiveness research of the innovative treatments has been called for to promote evidence-based practice and translational science in stroke motor rehabilitation. Wolf and Whitall called for rigorous comparisons between unilateral and bilateral training. McCombe Waller and Whitall also indicated the importance of combining unilateral with bilateral training. For low-functioning patients, robot-assisted training is a possible approach. Identifying possible determinants for unilateral and bilateral training outcomes may also elucidate the factors that influence treatment outcomes. Outcome measures are required that have good clinimetric properties for measuring the effects of the rehabilitation strategies.
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

Interventions

  • Task-related unilateral arm training Behavioral
    Other Names: Task-related UAT
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Therapist-conducted treatment
    Description: Three groups will be involved in this part of the whole project: task-related unilateral arm training, task-related bilateral arm training, and combined therapy coupling task-related unilateral with bilateral arm training.
    ARM 2: Kind: Experimental
    Label: Task-Related UAT
    Description: Therapist conducted unilateral arm training Task-related unilateral arm training
    ARM 3: Kind: Experimental
    Label: Task-Related UAT coupling BAT
    Description: 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 bilateral arm training Behavioral
    Other Names: Task-related BAT
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Therapist-conducted treatment
    Description: Three groups will be involved in this part of the whole project: task-related unilateral arm training, task-related bilateral arm training, and combined therapy coupling task-related unilateral with bilateral arm training.
    ARM 2: Kind: Experimental
    Label: Task-Related BAT
    Description: Therapist conducted bilateral arm Training Task-related bilateral arm training
    ARM 3: Kind: Experimental
    Label: Task-Related UAT coupling BAT
    Description: Therapist conducted task-related unilateral training for 45 minutes, followed by task-related bilateral arm training for another 45 minutes during each training session
  • Combined uni- and bi-lateral arm training Behavioral
    Other Names: Combined UAT and BAT
    Intervention Desc: Based on the described treatment principles for unilateral and bilateral training, the participants will receive unilateral training for 45 minutes, followed by bilateral training for another 45 minutes during each training session.
    ARM 1: Kind: Experimental
    Label: Therapist-conducted treatment
    Description: Three groups will be involved in this part of the whole project: task-related unilateral arm training, task-related bilateral arm training, and combined therapy coupling task-related unilateral with bilateral arm training.
  • Robot-assisted bilateral arm training Behavioral
    Other Names: Robot-assisted BAT
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Robot-assisted treatment
    Description: The part of this project will involve 2 treatment groups undergoing robot-assisted unilateral and bilateral training.
    ARM 2: Kind: Experimental
    Label: Robot-assisted BAT
    Description: Robot-assisted bilateral arm training
  • Robot-assisted unilateral arm training Behavioral
    Other Names: Robot-assisted UAT
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Robot-assisted treatment
    Description: The part of this project will involve 2 treatment groups undergoing robot-assisted unilateral and bilateral training.
    ARM 2: Kind: Experimental
    Label: Robot-assisted UAT
    Description: Robot-assisted unilateral arm training

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Movement time Baseline and change from baseline in movement time at 4 weeks No
Primary Motor units Baseline and change from baseline in motor units at 4 weeks No
Primary Elbow extension angle Baseline and change from baseline in elbow extension angle at 4 weeks No
Primary Lateral index Baseline and change from baseline in lateral index at 4 weeks No
Secondary Test of center of pressure (CoP) displacement Baseline and change from baseline in test of CoP displacement at 4 weeks No
Secondary Hand strength Baseline and change from baseline in hand strength at 4 weeks No
Secondary Electromyography (EMG) Baseline and change from baseline in EMG at 4 weeks No
Secondary Modified Ashworth Scale (MAS) Baseline, change from baseline in MAS at 2 weeks, and change from baseline in muscle tone at 4 weeks No
Secondary Fugl-Meyer Assessment (FMA) Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks No
Secondary Wolf Motor Function Test (WMFT) Baseline, change from baseline in WMFT at 2 weeks, and change from baseline in WMFT at 4 weeks No
Secondary Functional Independence Measure (FIM) Baseline, change from baseline in FIM at 2 weeks, and change from baseline in FIM at 4 weeks No
Secondary ABILHAND Questionnaire Baseline, change from baseline in ABILHAND Questionnaire at 2 weeks, and change from baseline in ABILHAND Questionnaire at 4 weeks No
Secondary Accelerometers Baseline, change from baseline in accelerometers data at 2 weeks, and change from baseline in accelerometers data at 4 weeks No
Secondary Stroke Impact Scale Version 3.0 (SIS 3.0) Baseline, change from baseline in SIS 3.0 at 2 weeks, and change from baseline in SIS 3.0 at 4 weeks No

Sponsors