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

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: Stroke; Hemiplegia
• Intervention / Treatment: Procedure: MRI and 3D CT scan

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

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

How is the study designed?

Number of groups / cohorts

1

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Thierry THOMAS, MD-PhD, CHU Saint-Etienne

Study record dates

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: hemiplegia; bone microarchitecture
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: 0701116; 2008-A00048-47 (Other Identifier: AFFSAPS)