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Completed

NCT Number: NCT02766985

Rasch-analysis of Clinical Severity in FSHD

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).

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Key information

Conditions

Facioscapulohumeral Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Genetic confirmation of FSHD (either FSHD-1 or FSHD-2)

Exclusion criteria

  • Do not understand English
  • Unable to provide informed consent

Treatment and study plan

Primary outcomes

  1. FSHD Clinical Severity Scale

    Time frame: 1 day

    Measure severity of FSHD.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Quantitative strength testing

    Time frame: 1 day

  6. Functional testing

    Time frame: 1 day

  7. Reparatory function testing

    Time frame: 1 day

  8. Patient-reported outcome

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: ROC-FSHD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 10, 2016
Registry last updated
Apr 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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