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Changes in and Determinants of Movement Performance, Functional Status, and Health-Related Quality of Life After Stroke Rehabilitation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Taiwan University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00780533
First received: October 24, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

A total of 144 stroke patients 6 -24 months post onset who are between 45 and 75 years old will be recruited. A randomized-blocks pretest and posttest control group design will be applied. Four groups will be involved in this project and the subjects will be stratified on two variables: impairment level of the hand and side of lesion. Randomization will be done in blocks of six and each block randomization scheme is within each stratum. Treatment regimens will be designed to ensure that patients in 4 groups receive equivalent intensity of treatment (5 days/week for 1.5 hours/day for 4 consecutive weeks) directly supervised by senior occupational therapists.

Brain and movement reorganization will be evaluated with fMRI and kinematic instrument, respectively before and after the 4-week intervention period. Clinical measures on motor impairment, daily function and quality of life will be assessed before, immediately and six months after intervention. Two examiners blind to group allocation will collaborate to provide both fMRI and kinematic evaluations and one of them will administer clinical measures. Before being allowed to work with subjects, the examiner competence will be assessed by principle investigator and co-principle investigators. Multivariate analyses of covariance will be used to examine change in brain activation, kinematic variables and clinical measures as a function of intervention while controlling for pretest data, age and onset post stroke. Multiple regression models will be established to examine the possible predictor(s) for functional outcome of each rehabilitation approach. Canonical correlation analyses will be conducted to quantify the relationship between brain/motor reorganization and clinical measures.


Condition
Stroke
Rehabilitation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Changes in and Determinants of Movement Performance, Functional Status, and Health-Related Quality of Life After Stroke Rehabilitation

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 70
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

a group of stroke patients

Criteria

Inclusion Criteria:

  1. able to reach Brunnstrom stage III or above for the proximal part of the affected upper limb(Brunnstrom, 1970);
  2. considerable nonuse of the affected upper limb (amount-of-use [AOU] score < 2.5 on the MAL) (Taub, Miller, Novack, et al. ,1993);
  3. no serious cognitive deficits (score > 24 on the Mini Mental-State Exam) (Folstein, Folstein, & McHugh, 1975);
  4. no balance problems compromising safety when wearing the constraint device; and,
  5. no excessive spasticity (Modified Ashworth Scale ≤ 2 at any joint of the upper limb) (Bohannon, & Smith, 1987).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780533

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keh-chung Lin, Organization: School of Occupational Therapy, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT00780533     History of Changes
Other Study ID Numbers: 200712088R
Study First Received: October 24, 2008
Last Updated: October 24, 2008
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014