Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone
September 8, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne
Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone: Evaluation Using Micro CT 3D High Resolution and by Magnetic Resonance Imaging (MRI)
In hemiplegic, there is very little data on the impact of neurological deficit on the microarchitecture independent of bone mineral density and composition of the bone marrow.
Rare studies have shown the relationship between some micro-architectural parameters and severity of neurological deficit.
There is no study in humans on the evolution of the parameters of the microarchitecture assessed by 3D micro-tomography in the early phase of the installation of neurological deficits after stroke, in terms of a bearing bone, tibia, that a non-load bearing bones, radius.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Each patient must answer several questionnaires about their calcium intake and its ability to perform everyday tasks.
They will also have 3 blood samples (15 ml each time), 3 measure of bone by 3D micro-tomography and 2 MRI examination.
These examinations and sampling will take place after 30 days after stroke onset (except for MRI) and again after three months and six months after the stroke (the same day as the medical follow-up visit).
Study Type
Observational
Enrollment (Actual)
10
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient aged at least 30 who have experienced a vascular hemiplegia within 30 days before enrollment
Description
Inclusion criteria
- at least 30 years
- vascular hemiplegia
- National Institute of Health Stroke Score equal 4 or greater with a motor of upper limb score greater than or equal 2 and a motor score of greater than or equal legs 2
Exclusion criteria
- Concomitant bone disease
- Endocrinopathies
- Phasic disorders understanding
- Contra-indication to MRI
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients
Patients who have experienced a vascular hemiplegia and accept bone measure by MRI and 3D CT scan
|
Measurement of bone microarchitecture at the legs and wrists by 3D CT Scan and measuring the proportion of fat in the imaging leg bone (MRI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone volume / tissue volume
Time Frame: 90 days
|
Measure of Bone volume / tissue volume by the 3D CT scan
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone volume / tissue volume
Time Frame: 1 day
|
Measure of Bone volume / tissue volume by the 3D CT scan
|
1 day
|
|
intraosseous fat
Time Frame: 90 days
|
Measure the percentage of the intraosseous fat by MRI
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thierry THOMAS, MD-PhD, CHU Saint-Etienne
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
June 1, 2009
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
September 7, 2015
First Submitted That Met QC Criteria
September 8, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Estimate)
September 9, 2015
Last Update Submitted That Met QC Criteria
September 8, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0701116
- 2008-A00048-47 (Other Identifier: AFFSAPS)
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.