- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00407628
Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies
July 4, 2013 updated by: National Taiwan University Hospital
To investigate the relationship between the integrity of the white matter, including the corticospinal tracts and the corpus callosum, with the recovery of lower extremity function in patients with cerebral stroke at the subacute and chronic stages.
Study Overview
Status
Completed
Conditions
Detailed Description
Recent studies have provided strong evidence that motor recovery after adult ischemic stroke is a function of neural plasticity.
Up to date, it remains largely unknown as to the relationship between the integrity of the subcortical white matter with the lower extremity function recovery.
Given the fact that the white matter is more resistant to ischemia after acute stroke than the gray matter (Falcao et al., 2004) and that the intensity of white matter in stroke has been found to be much greater in many brain areas in stroke than in healthy controls (Wen et al., 2004), it is of interest to study how the integrity of the subcortical white matter, primarily the corticospinal tracts and the corpus callosum, contributes to the recovery of lower extremity function in subacute and chronic stroke with lesions involving different areas of the brain.
Study Type
Observational
Enrollment (Actual)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taiwan
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Taipei, Taiwan, China
- School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
stroke patients
Description
Inclusion Criteria:
- between 30 to 80 years old
- diagnosis of the first-time onset of stroke as confirmed by imaging studies
- within 30 days post onset University Hospital
- brain lesions mainly involving either the cortical primary motor cortex (M1) area or confined to the subcortical (M1 spared)
- No neurological or orthopedic problems which would affect their lower extremity function
- no contraindications for MRI studies
Exclusion Criteria:
- medically unstable
- unable to communicate with the experimenters
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical assessments, included balance, motor, walking,ADL, will be obtained for tests performed on D7, D30 and D90
Time Frame: D30, D90 and D180 post stroke onset
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D30, D90 and D180 post stroke onset
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Pei-Fang Tang, PhD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
December 3, 2006
First Submitted That Met QC Criteria
December 3, 2006
First Posted (Estimate)
December 5, 2006
Study Record Updates
Last Update Posted (Estimate)
July 8, 2013
Last Update Submitted That Met QC Criteria
July 4, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9561703031
- NSC95-2314-B-002-238-MY3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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