Impact of Hemiplegia Due to Stroke on the Microarchitecture of the Bone

NCT ID: NCT02544386

Last Updated: 2015-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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

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Stroke Hemiplegia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients who have experienced a vascular hemiplegia and accept bone measure by MRI and 3D CT scan

MRI and 3D CT scan

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thierry THOMAS, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Other Identifiers

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2008-A00048-47

Identifier Type: OTHER

Identifier Source: secondary_id

0701116

Identifier Type: -

Identifier Source: org_study_id

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