StrokeNCT00407628
Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies
An observational study of Stroke, run by National Taiwan University Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Aug 2006to Jul 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: stroke patients
Who may be able to join
- 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
Who cannot join
- medically unstable
- unable to communicate with the experimenters
Trial locations and contacts
1 site in 1 country.
China1 site
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Taipei, Taiwan
About this study
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.
Read the 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.
- Conditions
- Stroke
- Keywords
- Stroke, Diffusion spectrum tractography, Functional MRI (fMRI), Lower extremity
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical assessments, included balance, motor, walking,ADL, will be obtained for tests performed on D7, D30 and D90
Measured: D30, D90 and D180 post stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Pei-Fang Tang, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407628
- Sponsor's protocol ID
- 9561703031
- Other IDs
- NSC95-2314-B-002-238-MY3
- Status last verified
- Jan 2013
- First submitted
- 3 Dec 2006
- Last updated
- 8 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies
- ClinicalTrials.gov ID
- NCT00407628
- Acronym / sponsor ID
- 9561703031
- Conditions
- Stroke
- Keywords
- Stroke, Diffusion spectrum tractography, Functional MRI (fMRI), Lower extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- medically unstable
- unable to communicate with the experimenters
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Fang Tang, PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by National Taiwan University Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.