Rasch-analysis of Clinical Severity in FSHD (ROC-FSHD)
|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
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|