RECRUITING

Motor Outcomes to Validate Evaluations in Pediatric FSHD (MOVE Peds)

Conditions

Muscular Dystrophy, Facioscapulohumeral FSHD Pediatric

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary goal of this study is to validate motor and functional outcomes and refine clinical trial strategies for pediatric-onset FSHD

Official Title

Motor Outcomes to Validate Evaluations in Pediatric FSHD (MOVE Peds)

Quick Facts

Study Start:2025-05-21

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06847282

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Age 5-17 years. * Genetically confirmed FSHD (types 1 or 2). * Symptomatic weakness (facial, shoulder, core, or limb weakness) * Able to complete a 10-meter walk without the support of another person in less than 12 seconds (canes, walking sticks, and braces allowed; no walker). In order to include early onset participants up to 8 individuals will be entered with baseline 10MWR \> 12 seconds or who are no longer ambulatory (≤10%)	* Unwilling or unable to provide informed consent or assent. Any other medical condition which in the opinion of the investigator would interfere with study participation. * Malignancy with ongoing treatment with chemotherapeutic agents or anabolic agents * Use of immunosuppressants including prednisone or performance enhancing drugs including testosterone within 6 months * Pregnancy * Recent or ongoing infection * Presence of contraindication to performance of MRI: pacemaker, metallic foreign body in eye, brain aneurysm clip (unless documented as MRI compatible) * In the opinion of the investigator unable to follow directions for standardized testing * Note: Not being able to complete MRI will not result in a screen failure. If subject is not able to complete the procedure due to fear or anxiety, they will have the opportunity to try again at later visits. However, Subject must be willing to attempt to perform the MRI to meet inclusion/exclusion criteria

Inclusion Criteria

Exclusion Criteria

* Age 5-17 years.
* Genetically confirmed FSHD (types 1 or 2).
* Symptomatic weakness (facial, shoulder, core, or limb weakness)
* Able to complete a 10-meter walk without the support of another person in less than 12 seconds (canes, walking sticks, and braces allowed; no walker). In order to include early onset participants up to 8 individuals will be entered with baseline 10MWR \> 12 seconds or who are no longer ambulatory (≤10%)

* Unwilling or unable to provide informed consent or assent. Any other medical condition which in the opinion of the investigator would interfere with study participation.
* Malignancy with ongoing treatment with chemotherapeutic agents or anabolic agents
* Use of immunosuppressants including prednisone or performance enhancing drugs including testosterone within 6 months
* Pregnancy
* Recent or ongoing infection
* Presence of contraindication to performance of MRI: pacemaker, metallic foreign body in eye, brain aneurysm clip (unless documented as MRI compatible)
* In the opinion of the investigator unable to follow directions for standardized testing
* Note: Not being able to complete MRI will not result in a screen failure. If subject is not able to complete the procedure due to fear or anxiety, they will have the opportunity to try again at later visits. However, Subject must be willing to attempt to perform the MRI to meet inclusion/exclusion criteria

Contacts and Locations

Study Contact

Michaela Walker, MPH

CONTACT

913-945-9920

mwalker20@kumc.edu

Rebecca Clay, BS

CONTACT

9139459936

rclay@kumc.edu

Principal Investigator

Jeffrey Statland, MD

PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

University of Iowa

Iowa City, Iowa, 52242

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

University of Rochester

Rochester, New York, 14642

United States

Duke University

Durham, North Carolina, 27708

United States

University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Jeffrey Statland, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-21

Study Completion Date2028-05

Study Record Updates

Study Start Date2025-05-21

Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

FSHD
Pediatric

Additional Relevant MeSH Terms

Muscular Dystrophy, Facioscapulohumeral