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Rasch-analysis of Clinical Severity in FSHD

Rasch-analysis of Clinical Severity in FSHD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02766985
Acronym
ROC-FSHD
Enrollment
44
Registered
2016-05-10
Start date
2016-03-31
Completion date
2017-04-18
Last updated
2018-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facioscapulohumeral Muscular Dystrophy

Keywords

FSHD, muscular dystrophy

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).

Interventions

None listed

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Do not understand English * Unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
FSHD Clinical Severity Scale1 dayMeasure severity of FSHD.

Secondary

MeasureTime frameDescription
Vignos scale1 dayMeasures 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)1 dayIOPI measures lip and tongue strength by measuring the amount of pressure a person can exert on the tool.
Manual muscle testing1 dayMeasure 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.
Brooks scale1 dayMeasures 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.
Functional testing1 day
Reparatory function testing1 day
Patient-reported outcome1 day
Quantitative strength testing1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026