Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

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
    

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.
    

Intervention name(s): Task-related unilateral arm training; Task-related bilateral arm training; Robot-assisted bilateral arm training; Robot-assisted unilateral arm training
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Other intervention name(s): Task-related UAT; Task-related BAT; Robot-assisted BAT; Robot-assisted UAT
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke rehabilitation; Unilateral arm training; Bilateral arm training; Robot-assisted arm training; Kinematic analysis; Functional magnetic resonance image; Motor recovery; Quality of life