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 ]

Measure severity of FSHD.


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