Recruiting

MSO EvaluationMotor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)

Sponsor:

University of Kansas Medical Center

Code:

NCT04635891

Conditions

FSHD

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

FSHD

Study ID

NCT04635891

Start date

Dec 15, 2020

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Genetically confirmed FSHD (types 1 or 2) or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring.

Exclusion Criteria:

Unwilling or unable to provide informed consent.
Any other medical condition which in the opinion of the investigator would interfere with study participation.

Study Design

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

MOVE FSHD Study Visits

Patients will receive standard of care as determined by their treating physician. Study visits will occur per standard of care and are anticipated to occur at least once a year.

Primary outcome measure

10m walk/run [ Time Frame: Baseline - 5 years ]
Shoulder and Arm Range of Motion [ Time Frame: Baseline - 5 years ]
Shoulder and Arm Function [ Time Frame: Baseline - 5 years ]
Spirometry (FVC, FEV1, PCF) [ Time Frame: Baseline - 5 years ]

Central Contacts and Locations

Central contacts

Michaela Walker, MPH

913-945-9920 mwalker20@kumc.edu

Leann Lewis, MSGC

585-275-7680 Leann_Lewis@URMC.Rochester.edu

Locations

David Geffen School of Medicine at UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Dova Levin

310-825-3264 dvlevin@mednet.ucla.edu

Merve Kaleli

310-825-3264 MKaleli@mednet.ucla.edu

Principal Investigator:

Perry Shieh, MD, PhD

Neuromuscular Disorders Program at Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94306

Contacts

650-725-4341 NeuromuscularResearch@stanford.edu

Principal Investigator:

John Day, MD, PhD

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

303-724-4644 neurologyresearchpartners@cuanschutz.edu

Principal Investigator:

Stacy Dixon, MD

Univeristy of Florida Gainesville

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Julie Segura

352-733-2412 Julie.segura@neurology.ufl.edu

Principal Investigator:

Subramony H Subramony, MD

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Catherine Buescher, MS, BHS

319-353-6269 catherine-buescher@uiowa.edu

Carrie Stephan, MA, BSN, RN

319-356-2673 carrie-stephan@uiowa.edu

Principal Investigator:

Katherine Mathews, MD

Univeristy of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Andrea Klempnauer

913-574-0008 atenney@kumc.edu

Rebecca Clay

913-945-9936 rclay@kumc.edu

Principal Investigator:

Jeffrey Statland, MD

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Mary Yep

443-923-7318 Yep@kennedykrieger.org

Geni Bibat

423-923-2629 bibat@kennedykrieger.org

Principal Investigator:

Doris Leung, MD, PhD

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Leann Lewis, MS

585-275-7680 Leann_Lewis@URMC.Rochester.edu

Marisa Rosenberg

585-274-0271 Marisa_Rosenberg@URMC.Rochester.edu

Principal Investigator:

Rabi Tawil, MD

Duke University - Lenox Baker Children's Hospital

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Randy Smith, MPH

919-684-1586 randy.s.smith@duke.edu

Stepanie Thera

stephanie.thera@duke.edu

Principal Investigator:

Natalie Katz, MD, PhD

The Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Alison Arter

614-685-8661 Alison.Arter@osumc.edu

Marco Tellez

614-688-7837 Marco.Tellez@osumc.edu

Principal Investigator:

Bakri Elsheikh, MD

Austin Neuromuscular Center

Recruiting

Austin, Texas, United States, 78759

Contacts

Hina Patel

512-920-0140 hina@austinneuromuscle.com

Emil Hussain

512-920-0140 emil@austinneuromuscle.com

Principal Investigator:

Yessar Hussain, MD

Univeristy of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Tyler Arrington

214-645-2759 Tyler.Arrington@UTSouthwestern.edu

Steve Hopkins

214-648-9380 Steve.Hopkins@UTSouthwestern.edu

Principal Investigator:

Jaya Trivedi, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Ryan Kennington

801-587-0833 ryan.kennington@hsc.utah.edu

Caroline Flood

Caroline.Flood@hsc.utah.edu

Principal Investigator:

Russell Butterfield, MD, PhD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Resheed Reid

646-804-2367 resheed.reid1@vcuhealth.org

Levi Headrick

804-828-6110 levi.headrick@vcuhealth.org

Principal Investigator:

Nicholas Johnson, MD

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Lilly Young

eyoung@uw.edu

Principal Investigator:

Leo Wang, MD, PhD

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1y 4e9

Contacts

Jessica Belanger

613-798-5555 jemacgregor@ohri.ca

Kathryn Beaudry

617-798-5555 kabeaudry@ohri.ca

Principal Investigator:

Hanns Lochmuller, MD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-05-07.