Stroke Clinical Trial
Official title:
Changes in and Determinants of Movement Performance, Functional Status, and Health-Related Quality of Life After Stroke Rehabilitation
Verified date | October 2008 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 71 Years |
Eligibility |
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). |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
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