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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Chang Gung Memorial Hospital
Sponsor:
Collaborators:
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01525979
First received: January 30, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention
Cerebrovascular Accident
Behavioral: Task-related unilateral arm training
Behavioral: Task-related bilateral arm training
Behavioral: Robot-assisted bilateral arm training
Behavioral: Robot-assisted unilateral arm training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Efficacy Research of Uni- vs Bi-lateral Arm Training Poststroke: Task-Related or Robotic

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Movement time [ Time Frame: Baseline and change from baseline in movement time at 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Motor units [ Time Frame: Baseline and change from baseline in motor units at 4 weeks ] [ Designated as safety issue: No ]
    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.

  • Elbow extension angle [ Time Frame: Baseline and change from baseline in elbow extension angle at 4 weeks ] [ Designated as safety issue: No ]
    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

  • Lateral index [ Time Frame: Baseline and change from baseline in lateral index at 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Test of center of pressure (CoP) displacement [ Time Frame: Baseline and change from baseline in test of CoP displacement at 4 weeks ] [ Designated as safety issue: No ]
    The 2 force plates is adopted to obtain the center of pressure (CoP) displacement representing balance performance during standing reaching.

  • Hand strength [ Time Frame: Baseline and change from baseline in hand strength at 4 weeks ] [ Designated as safety issue: No ]
    Hand-held dynamometers will be the devices that measure the hand strength.

  • Electromyography (EMG) [ Time Frame: Baseline and change from baseline in EMG at 4 weeks ] [ Designated as safety issue: No ]
    Raw EMG activities from the muscles of interest during unilateral and bilateral reaching while the patient is sitting and standing will be recorded using the AcqKnowledge data analysis software.

  • Modified Ashworth Scale (MAS) [ Time Frame: Baseline, change from baseline in MAS at 2 weeks, and change from baseline in muscle tone at 4 weeks ] [ Designated as safety issue: No ]
    The MAS scale is an ordinal scale (0-5 points) assessing spasticity of skeletal muscle in UE. A higher score indicating more spasticity.

  • Fugl-Meyer Assessment (FMA) [ Time Frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks ] [ Designated as safety issue: No ]
    The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.

  • Wolf Motor Function Test (WMFT) [ Time Frame: Baseline, change from baseline in WMFT at 2 weeks, and change from baseline in WMFT at 4 weeks ] [ Designated as safety issue: No ]
    The WMFT is a function-based motor assessment of 17 tasks, including 15 timed and functional ability tasks (fine and gross motor tasks) and 2 strength tasks (lifting and handgrip).

  • Functional Independence Measure (FIM) [ Time Frame: Baseline, change from baseline in FIM at 2 weeks, and change from baseline in FIM at 4 weeks ] [ Designated as safety issue: No ]
    The FIM consists of 18 items grouped into 6 subscales. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks.

  • ABILHAND Questionnaire [ Time Frame: Baseline, change from baseline in ABILHAND Questionnaire at 2 weeks, and change from baseline in ABILHAND Questionnaire at 4 weeks ] [ Designated as safety issue: No ]
    ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.

  • Accelerometers [ Time Frame: Baseline, change from baseline in accelerometers data at 2 weeks, and change from baseline in accelerometers data at 4 weeks ] [ Designated as safety issue: No ]
    Accelerometers quantitatively record the amount of activity in free-living conditions and will be used to reflect the amount of affected arm use over time.

  • Stroke Impact Scale Version 3.0 (SIS 3.0) [ Time Frame: Baseline, change from baseline in SIS 3.0 at 2 weeks, and change from baseline in SIS 3.0 at 4 weeks ] [ Designated as safety issue: No ]
    The SIS 3.0 contains 59 items measuring 8 domains. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Task-Related UAT
Therapist conducted unilateral arm training Task-related unilateral arm training
Behavioral: 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.
Other Name: Task-related UAT
Experimental: Task-Related BAT
Therapist conducted bilateral arm Training Task-related bilateral arm training
Behavioral: 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.
Other Name: Task-related BAT
Experimental: 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
Behavioral: 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.
Other Name: Task-related UAT
Behavioral: 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.
Other Name: Task-related BAT
Experimental: Robot-assisted UAT
Robot-assisted unilateral arm training
Behavioral: 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 Name: Robot-assisted UAT
Experimental: Robot-assisted BAT
Robot-assisted bilateral arm training
Behavioral: 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.
Other Name: Robot-assisted BAT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40 to 75 years old
  • 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:

  • Physician-determined major medical problems or poor physical condition that would interfere with participation
  • Excessive pain in any joint that might limit participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525979

Contacts
Contact: Ching-yi Wu, ScD 886-3-2118800 ext 5761 cywu@mail.cgu.edu.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan County, Taiwan
Contact: Chia-ling Chen, MD/PhD    886-3-3281200 ext 8148    ccl1374@adm.cgmh.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: Ching-yi Wu, ScD Chang Gung University
  More Information

No publications provided by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01525979     History of Changes
Other Study ID Numbers: 99-0832B, NHRI-EX100-10010PI
Study First Received: January 30, 2012
Last Updated: January 29, 2014
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Stroke rehabilitation
Unilateral arm training
Bilateral arm training
Robot-assisted arm training
Kinematic analysis
Functional magnetic resonance image
Motor recovery
Quality of life

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014