1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy (FSHD)
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|ClinicalTrials.gov Identifier: NCT02159612|
Recruitment Status : Completed
First Posted : June 10, 2014
Last Update Posted : May 14, 2015
|Condition or disease||Intervention/treatment|
|FSHD - Facioscapulohumeral Muscular Dystrophy||Other: MRI|
A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan to describe the relation between backpain and disease affection in back muscles. After one year they are re-invited to perform another MRI scan to follow the disease progression.
The MRI scan is done to measure the quantity and quality of the muscles in the back, thigh and calf. Further, investigators investigate the muscle function by measuring of muscle strength in legs and in the back together with three functional tests. A walking test (6MWT), a stair test (14SST), and a chair test (5-TSTST). Self-assessment of back pain is measured by a standardized questionnaire about backpain.
|Study Type :||Observational|
|Actual Enrollment :||45 participants|
|Official Title:||Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan.
MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.
- Fat infiltration [ Time Frame: 1 year ]Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.
- Muscle structure [ Time Frame: 1 year ]Muscle structure is evaluated with a four-point semi-quantitative visual scale. Two observers evaluate images independently. Changes in evaluation between 1st and 2nd scan are the outcome measure.
- Muscle strength [ Time Frame: 1 year ]Changes in muscle strength between 1st. and 2nd MRI-scan.
- Back pain [ Time Frame: 1 year ]Changes in self-assessed back-pain between 1st. and 2nd scan.
- Muscle function [ Time Frame: 1 year ]Changes in muscle function between 1st and 2nd MRI-scan, measured by a 6 minute walk test, a 14-step-stair test and a 5-times-sit-to-stand-test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159612
|Neuromuscular Research Unit, Department of Neurology, Rigshospitalet|
|Copenhagen, Denmark, 2100|