Clinical trial NCT01908361: Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke
Official title: Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: comparative efficacy research
combination therapy
neurorehabilitation
robotic rehabilitation
restraint therapy
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Fugl-Meyer Assessment (FMA)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Wolf Motor Function Test (WMFT)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
Secondary outcomes:
measure: Change in MyotonPro
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in 10-Meter Walk Test (10MWT)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Actigraphy
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Functional Independence Measure (FIM)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Motor Activity Log (MAL)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in ABILHAND Questionnaire
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Physiologic Response Measures (Biomarkers)
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
measure: Change in Kinematic analysis
timeFrame: Baseline, 3 weeks, 6 weeks, and 18 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Buddhist Tzu Chi General Hospital Taipei Branch
Study officials:
affiliation: School of Occupational Therapy, College of Medicine, National Taiwan University, Taiwan
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buddhist Tzu Chi General Hospital Taipei Branch
name: Yi-shiung Horng, PhD
role: PRINCIPAL_INVESTIGATOR
References: