1 Year MRI Followup in Facioscapulohumeral Muscular Dystrophy (FSHD)

May 13, 2015 updated by: Grete Andersen, MD

Disease Progression in Facioscapulohumeral Muscular Dystrophy - 1 Year MRI Follow-up

An investigation of disease progression in adult danish patients with facioscapulohumeral muscular dystrophy. The disease progression is followed for a year with two test-days, including functional muscle tests and a MRI scan of muscles in the back and legs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Neuromuscular Research Unit, Department of Neurology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons in Denmark diagnosed with Facioscapulohumeral muscular dystrophy is invited to the study.

Description

Inclusion Criteria:

  • Diagnosed with FSHD type 1

Exclusion Criteria:

  • Pregnant or breastfeeding women.
  • Patients with claustrophobia.
  • Patients with implanted metallic parts in the body.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
FSHD
A cohort of adult danish patients with facioscapulohumeral muscular dystrophy is invited to perform a MRI scan.
Other: MRI
MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fat infiltration
Time Frame: 1 year
Change in the distribution of fat infiltration in back, thigh and calves muscles seen at the MRI images.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Muscle strength
Time Frame: 1 year
Changes in muscle strength between 1st. and 2nd MRI-scan.
1 year
Back pain
Time Frame: 1 year
Changes in self-assessed back-pain between 1st. and 2nd scan.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grete Andersen, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-3-2012-163 (fsh)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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