Motor Outcomes to Validate Evaluations in Pediatric FSHD (MOVE Peds)
Recruiting now
Conditions studied: Muscular Dystrophy, Facioscapulohumeral
In brief
The primary goal of this study is to validate motor and functional outcomes and refine clinical trial strategies for pediatric-onset FSHD
Key facts
- Study ID
- NCT06847282
- Run by
- University of Kansas Medical Center
- People needed
- 80
- Starts
- 2025-05-22
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-02-25
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%)
You may not qualify if…
- 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
Where it is running
- University of Rochester — Rochester, New York, United States (enrolling)
- University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
- Duke University — Durham, North Carolina, United States (enrolling)
- Murdoch Children's Research Institute — Melbourne, Australia (enrolling)
- University of Iowa — Iowa City, Iowa, United States
- University of Utah — Salt Lake City, Utah, United States
- Stanford University — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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