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

Terminated

• Conditions: Stroke; Hemiplegia
• Interventions: Procedure: MRI and 3D CT scan

• Registration Number: NCT02544386
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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. 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 Timeline

• Study Start: 2009-06
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-09
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Bone volume / tissue volume	90 days	Measure of Bone volume / tissue volume by the 3D CT scan

Secondary Outcome Measures

Name	Time	Method
Bone volume / tissue volume	1 day	Measure of Bone volume / tissue volume by the 3D CT scan
intraosseous fat	90 days	Measure the percentage of the intraosseous fat by MRI