Rasch-analysis of Clinical Severity in FSHD (ROC-FSHD)
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|ClinicalTrials.gov Identifier: NCT02766985|
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : April 12, 2018
|Condition or disease|
|Facioscapulohumeral Muscular Dystrophy|
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Rasch-analysis of Clinical Severity in FSHD|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||April 18, 2017|
|Actual Study Completion Date :||April 18, 2017|
Participants with FSHD-1 or FSHD-2. No intervention is given to participants. Participants will undergo series of tests and procedures in order to make a standardized and scalable Rasch-built clinical severity scale.
- FSHD Clinical Severity Scale [ Time Frame: 1 day ]Measure severity of FSHD.
- Brooks scale [ Time Frame: 1 day ]Measures upper extremity function.Scores on the scale range from 1-6. A score of 1 means the person can elevate their arms above their head while arms remain straight. 6 means the person cannot elevate their arms to their mouth and do not have useful function of their hands.
- Vignos scale [ Time Frame: 1 day ]Measures lower extremity function. Scores on the scale range from 1-10. A score of 1 means the person can walk and climb stairs without assistance. A score of 10 means the person is bedridden.
- Iowa Oral Performance Instrument (IOPI) [ Time Frame: 1 day ]IOPI measures lip and tongue strength by measuring the amount of pressure a person can exert on the tool.
- Manual muscle testing [ Time Frame: 1 day ]Measure person's range of motion. Scored on a scale with range of 0-5. Score of 0 means no movement. Score of 5 means the person has a full range of movement.
- Quantitative strength testing [ Time Frame: 1 day ]
- Functional testing [ Time Frame: 1 day ]
- Reparatory function testing [ Time Frame: 1 day ]
- Patient-reported outcome [ Time Frame: 1 day ]
Biospecimen Retention: Samples With DNA
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): NCT02766985
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Jeffrey Statland, MD||University of Kansas Medical Center|