Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Completed NCT00784706 - Effect of Combined Therapy on Neglect Syndrome in Stroke Patients N/A
Recruiting NCT04188457 - Medical-economic Evaluation Comparing Intensive Outpatient Monitoring of Neuro-cardiovascular Diseases by Nurses, Doctors and Hospital and Private-sector Pharmacists, Compared to Usual Monitoring.
Completed NCT03964610 - Multimodal Retinal Imaging of Cerebrovascular Stroke
Recruiting NCT02544672 - Function Benefits of a Myoelectric Elbow-Wrist-Hand Orthosis N/A
Recruiting NCT00917605 - Robot-Assisted Therapy in Stroke Patients N/A
Completed NCT00564005 - Mechanism and Efficacy of Rehabilitation Approaches N/A
Completed NCT03639116 - Spinal Plasticity to Reduce Hand Impairment After Stroke N/A
Completed NCT01409265 - The Impact of Perceptual Impairment on Social Participation in Stroke Patients N/A
Completed NCT00263393 - Rural Andhra Pradesh Cardiovascular Prevention Study (RAPCAPS) Phase 4
Recruiting NCT00173797 - Comparison of Psychometric Properties of Three Depression Measures in Patients With Stroke N/A
Recruiting NCT00173810 - Development of a Refined Version of the Stroke Rehabilitation Assessment of Movement Scale for Stroke Patients N/A
Recruiting NCT00173771 - Development of a Comprehensive ADL Scale for Stroke Patients N/A