Mechanism and Efficacy of Rehabilitation Approaches

Cerebrovascular Accidents Clinical Trial

Official title:

Mechanisms and Long-term Effects of Separate vs. Coupled Rehabilitation Approaches After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564005
• Other study ID #: NHRI-EX97-9742PI
• Secondary ID: 96-0252B
• Status: Completed
• Phase: N/A
• First received: November 25, 2007
• Last updated: February 10, 2015
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2014
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.

Description:

Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• a first-ever clinical cerebrovascular accident patients

• at least 6 months post-stroke onset

• premorbid right-hand dominance

• demonstration of Brunnstrom stage III of the affected upper extremity

• no excessive spasticity in the joints of the affected upper extremity

Exclusion Criteria:

• a score of less than 24 on the Mini Mental State Exam

• poor physical conditions that would interfere with participation

• excessive pain in any joint that might limit participation

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:
• Constraint-induced therapy (CIT)
restraint of the unaffected arm and practice of the affected arm
• Bilateral arm training (BAT)
bilateral symmetric, repetitive arm training
• Combined therapy (CT)
combined different treatment approaches

Behavioral:
• Control intervention
Conventional treatment program

Locations

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

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	Cortical reorganization and kinematic analysis		2008-2010	Yes
Secondary	clinical measures at the impairment, activity, participation levels		2008-2010	Yes