Contractile Cross Sectional Areas and Muscle Strength in Patients With Inherited Muscle Diseases
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ClinicalTrials.gov Identifier: NCT03018184 |
Recruitment Status
:
Recruiting
First Posted
: January 11, 2017
Last Update Posted
: January 12, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Inherited Muscle Diseases Congenital Myopathy RYR1-myopathy | Other: MRI and Muscle Dynamometer |
Study Type : | Observational |
Estimated Enrollment : | 200 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
Official Title: | Contractile Cross Sectional Areas and Muscle Strength in Patients With Inherited Muscle Diseases as Compared to Healthy Individuals |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2026 |

- Muscle CCSA, investigated by Dixon MRI techniques. [ Time Frame: MRI scan per subject lasts approximately 60 minutes. ]The MRI protocol include a whole body scan. The calf and thigh are chosen for qualitative analysis. Cross sectional area is calculated, the amount of adipose tissue is calculated, and the amount of adipose tissue is subtracted from the CSA, resulting in the CCSA.
- Muscle strength, measured as peak torque, investigated by an isokinetic dynamometer (Biodex 4). [ Time Frame: The tests takes less than an hour per subject. ]The dynamometer makes it possible to isolate particular muscle groups. It is possible to control the range of motion and thereby test in an area free of pain.
- Muscle Strength, MRC [ Time Frame: The exam lasts less than 15 min per subject. ]Assessment of the muscle strength by a clinical test using "the Medical Research Council Scale for muscle strength" (MRC-scale).

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Verified inherited muscle disease.
- Age: Over 18 years old
Exclusion Criteria:
- Contraindications for an MRI.
- Claustrophobia.
- Pregnant or nursing women.
- Competing disorders (as arthritis) or other muscle disorders.

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): NCT03018184
Contact: Anne-Sofie V Eisum, BSc Med | 35456135 | anne-sofie.vibaek.eisum.01@regionh.dk | |
Contact: Freja Fornander, BSc Med | 35456135 | tove.freja.maria.fornander@regionh.dk |
Denmark | |
Copenhagen Neuromuscular Center, Rigshospitalet | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Anne-Sofie V Eisum, Bach. Med. 35458748 anne-sofie.vibaek.eisum.01@regionh.dk |
Principal Investigator: | John Vissing, MD DMSc | Copenhagen Neuromuscular Center, Rigshospitalet |
Publications:
Responsible Party: | Anne-Sofie Vibæk Eisum, BSc Med., Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT03018184 History of Changes |
Other Study ID Numbers: |
H-16045346 |
First Posted: | January 11, 2017 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Anne-Sofie Vibæk Eisum, Rigshospitalet, Denmark:
MRI CCSA Contractile Cross Sectional Area Strength |
Additional relevant MeSH terms:
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases |