Rasch-analysis of Clinical Severity in FSHD

NCT ID: NCT02766985

Last Updated: 2018-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-04-18

Brief Summary

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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 Description

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Conditions

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Facioscapulohumeral Muscular Dystrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FSHD

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Do not understand English
* Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey Statland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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UL1TR000001

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003640

Identifier Type: -

Identifier Source: org_study_id

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