StrokeNCT02544386
Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone
An observational study of Stroke and Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- MRI and 3D CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient aged at least 30 who have experienced a vascular hemiplegia within 30 days before enrollment
Who may be able to join
- 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
Who cannot join
- Concomitant bone disease
- Endocrinopathies
- Phasic disorders understanding
- Contra-indication to MRI
About this study
Official title: 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.
Read the 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).
- Conditions
- Stroke, Hemiplegia
- Being tested
- MRI and 3D CT scan
- Keywords
- bone microarchitecture, hemiplegia
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and 3D CT scanProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who have experienced a vascular hemiplegia and accept bone measure by MRI and 3D CT scan Receives: Procedure: MRI and 3D CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume / tissue volume
Measure of Bone volume / tissue volume by the 3D CT scan
Measured: 90 days
Secondary outcomes (2)
Bone volume / tissue volume
Measure of Bone volume / tissue volume by the 3D CT scan
Measured: 1 day
intraosseous fat
Measure the percentage of the intraosseous fat by MRI
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJun 2009
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: Inclusion rhythm too slow
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry THOMAS, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544386
- Sponsor's protocol ID
- 0701116
- Other IDs
- 2008-A00048-47
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02544386
- Acronym / sponsor ID
- 0701116
- Conditions
- Stroke, Hemiplegia
- Keywords
- bone microarchitecture, hemiplegia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusion rhythm too slow
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 9 Sep 2015 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: MRI and 3D CT scanPatients who have experienced a vascular hemiplegia and accept bone measure by MRI and 3D CT scan |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged at least 30 who have experienced a vascular hemiplegia within 30 days before enrollment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Concomitant bone disease
- Endocrinopathies
- Phasic disorders understanding
- Contra-indication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and 3D CT scanMeasurement of bone microarchitecture at the legs and wrists by 3D CT Scan and measuring the proportion of fat in the imaging leg bone (MRI) | Procedure or surgery | Patients |
Primary outcome
Bone volume / tissue volume
Time frame: 90 days
Measure of Bone volume / tissue volume by the 3D CT scan
2 secondary outcomes
Bone volume / tissue volume
Time frame: 1 day
intraosseous fat
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Inclusion rhythm too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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.
Thierry THOMAS, MD-PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiplegia, run by Centre Hospitalier Universitaire de Saint Etienne.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 9 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Inclusion rhythm too slow). Results are not available in the source record.
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?
Bone volume / tissue volume (time frame: 90 days). 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 9 Sep 2015.