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

Cerebrovascular Accidents Clinical Trial

Official title:

Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778453
• Other study ID #: NSC97-2314-B-182-004-MY3
• Secondary ID: 96-1754B
• Status: Completed
• Phase: N/A
• First received: October 5, 2008
• Last updated: July 31, 2012
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2012
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accidents
• Stroke

Intervention

Other:
• Hospital-based mCIT
restraint of the unaffected arm and practice of the affected arm
• Hospital-based BIT
bilateral symmetric, repetitive arm training
• Hospital-based TR
hospital-based traditional rehabilitation : OT or PT or therapist-based training
• Home-based mCIT
restraint of the unaffected arm and practices of the affected arm
• Home-based BAT
bilateral symmetric, repetitive arm training
• Home-based TR
home-based traditional rehabilitation:OT or PT or therapist-based training

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kwei-shan	Toayuan

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Health Research Institutes, Taiwan, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kinematic analysis		2008-2011	Yes
Secondary	clinical measures		2008-2011	Yes