RecruitingNCT04635891

Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

Sponsor

University of Kansas Medical Center

Enrollment

450 participants

Start Date

Dec 15, 2020

Study Type

OBSERVATIONAL

Conditions

FSHD

Summary

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) will have approximately 450 FSHD participants followed for a minimum of 3 years. A subset of MOVE FSHD participants, approximately 200, will participate in the MOVE+ sub-study which includes whole body MRI and reachable workspace, as well as optional muscle biopsy and wearable device (US participants only).

Eligibility

Plain Language Summary

Simplified for easier understanding

MOVE FSHD is a long-term observational study tracking motor function, breathing, mobility, and other health outcomes in people with facioscapulohumeral muscular dystrophy (FSHD) — a genetic muscle disease — over at least 3 years. The goal is to identify which measurements are most meaningful to patients and most useful for measuring drug effects in future clinical trials. Adults with genetically confirmed FSHD, or a clinical diagnosis with an affected parent or sibling, are eligible. Participation involves periodic assessments of strength, function, and walking ability, with an optional sub-study that includes full-body MRI and optional muscle biopsy and wearable activity tracker. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(21)

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Neuromuscular Disorders Program at Stanford University School of Medicine

Stanford, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Univeristy of Florida Gainesville

Gainesville, Florida, United States

University of Iowa

Iowa City, Iowa, United States

Univeristy of Kansas Medical Center

Kansas City, Kansas, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke University - Lenox Baker Children's Hospital

Durham, North Carolina, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Austin Neuromuscular Center

Austin, Texas, United States

Univeristy of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Texas Health San Antonio

San Antonio, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University

Richmond, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

University of Sao Paulo

São Paulo, Brazil

University of Calgary

Calgary, Alberta, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

University of McGill

Montreal, Quebec, Canada

Sheffield Teaching Hospital

Sheffield, South Yorkshire, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04635891

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