Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients

Not Applicable

Completed

• Conditions: Cerebrovascular Accidents
• Interventions: Other: Hospital-based mCIT; Other: Hospital-based BIT; Other: Hospital-based TR; Other: Home-based BAT; Other: Home-based TR; Other: Home-based mCIT

• Registration Number: NCT00778453
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from certain treatment approach. Accordingly, the results of this project may help us move quickly to design and develop efficient and effective rehabilitation programs for individualized patients.

Detailed Description

The first purpose is to investigate the relative effects of modified constraint-induced therapy (mCIT) vs. bilateral isokinematic training (BIT) vs. traditional or therapist-based training (TR) on movement reorganization, motor performance, functional ability, and quality of life (QoL) immediately and six months later after treatment delivered at hospitals. Movement reorganization will be evaluated by kinematic instrument. Motor performance, functional ability, and QoL will be assessed using clinical assessment tools. By the same token, we also investigate the relative effects of these two approaches delivered at home. The second purpose is to study whether home-based mCIT is efficacious in various aspects of outcomes described above immediately and six months later following treatment, compared to home-based TR, and hospital-based mCIT and TR.We also study the same question regarding home-based BIT efficacy. The third purpose is to establish predictive models to predict functional and QoL outcomes immediately and six months later following mCIT and BIT.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-10-05
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-23
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• the onset duration more than 6 months
• Brunnstrom stage III above for the proximal part and distal part of UL
• no serious cognitive deficits
• no balance problems sufficient to compromise safety when wearing the project's constraint device
• no excessive spasticity in any of the joints of the affected UL exclusion criteria:
• a score of less than 24 on the Mini Mental State Exam

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital-based mCIT	Hospital-based mCIT	Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based BIT	Hospital-based BIT	Hospital-based bilateral isokinematic training (BIT)
Hospital-based TR	Hospital-based TR	Hospital-based traditional rehabilitation (TR)
Home-based BAT	Home-based BAT	Home-based bilateral arm training(BAT)
Home-based TR	Home-based TR	Home-based traditional rehabilitation (TR)
Home-based mCIT	Home-based mCIT	Home-based modified constraint-induced therapy (mCIT)

Primary Outcome Measures

Name	Time	Method
kinematic analysis	2008-2011

Secondary Outcome Measures

Name	Time	Method
clinical measures	2008-2011

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kwei-shan, Toayuan, Taiwan