Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebrovascular Accident
- Sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Locations
- 1
- Primary Endpoint
- Change in Fugl-Meyer Assessment (FMA)
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief Summary
In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate clinical trials: one to recruit subacute stroke patients and another to recruit chronic stroke patients. The two trials will have identical study designs and interventions. The overall goal of this research project is to provide scientific evidence of the treatment effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients and thus to contribute to evidence-based stroke rehabilitation and translational research for neurorehabilitation.
Detailed Description
The first aim of the project will be to compare treatment effects between hybrid rehabilitation and conventional rehabilitations (CR) on motor function, daily functions, mobility, quality of life, and kinematic variables. We hypothesize that patients receiving hybrid rehabilitation will gain more recovery than patients receiving CR in proximal (e.g., motor function) and in distal outcomes (e.g., quality of life) and that patients in the hybrid rehabilitation groups will show more genuine upper extremity motor recovery than those in conventional rehabilitation groups, as indicated by kinematic measures. The second aim will be to examine the comparative treatment effects between unilateral hybrid and bilateral hybrid rehabilitation on various aspects of outcomes. We hypothesize that the unilateral group will improve more on outcomes associated with distal upper limb (UL) control and that the bilateral rehabilitation group will improve more on outcomes associated with proximal UL control. Third, we will collect biomarker indexes before and after the interventions to monitor the changes of oxidative stress and inflammatory levels.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 to 6 months onset from a first-ever unilateral stroke for the subacute randomized controlled trial (RCT), and more then 6 months after onset for the chronic RCT
- •minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits)
- •an initial FMA-UE score of 18 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment
- •no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers)
- •able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 24)
- •without upper extremity fracture within 3 months
- •no participation in any rehabilitation experiments or drug studies during the study period
- •willing to provide written informed consent
Exclusion Criteria
- •acute inflammatory disease
- •major health problems or poor physical condition that might limit participation
Outcomes
Primary Outcomes
Change in Fugl-Meyer Assessment (FMA)
Time Frame: Baseline, 3 weeks, 6 weeks, and 18 weeks
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
Change in Wolf Motor Function Test (WMFT)
Time Frame: Baseline, 3 weeks, 6 weeks, and 18 weeks
The WMFT was originally designed to assess the effects of CIT on the return of arm function for stroke and traumatic brain injury. The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients.
Secondary Outcomes
- Change in Functional Independence Measure (FIM)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Motor Activity Log (MAL)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Physiologic Response Measures (Biomarkers)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in MyotonPro(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in 10-Meter Walk Test (10MWT)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Actigraphy(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Stroke Impact Scale Version 3.0 (SIS 3.0)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Kinematic analysis(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in ABILHAND Questionnaire(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Nottingham Extended Activities of Daily Living Scale (NEADL)(Baseline, 3 weeks, 6 weeks, and 18 weeks)