Clinical Trial: Rasch-analysis of Clinical Severity in FSHD
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: Rasch-analysis of Clinical Severity in FSHD
Brief Summary: The purpose of this study is to make a standardized and scalable Rasch-built clinical severity scale to help in finding genetic and environmental modifiers of disease in Facioscapulohumeral muscular dystrophy (FSHD).
Detailed Summary:
Sponsor: University of Kansas Medical Center
Current Primary Outcome: FSHD Clinical Severity Scale [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: University of Kansas Medical Center
Dates:
Date Received: March 22, 2016
Date Started: March 2016
Date Completion: September 2017
Last Updated: December 8, 2016
Last Verified: December 2016