Clinical trial NCT00778453: Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients
Official title: Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accidents
Keywords: stroke rehabilitation
kinematic analysis
upper extremity training
predictors
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2008-10-23
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: kinematic analysis
timeFrame: 2008-2011
Secondary outcomes:
measure: clinical measures
timeFrame: 2008-2011
Other outcomes:
Locations:
city: Kwei-shan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Toayuan
Study officials:
affiliation: Department of Occupational Therapy, Chang Gung Univ
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.