RecruitingNCT06847282
Motor Outcomes to Validate Evaluations in Pediatric FSHD (MOVE Peds)
Sponsor
University of Kansas Medical Center
Enrollment
80 participants
Start Date
May 22, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
The primary goal of this study is to validate motor and functional outcomes and refine clinical trial strategies for pediatric-onset FSHD
Eligibility
Min Age: 5 YearsMax Age: 17 Years
Inclusion Criteria4
- 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%)
Exclusion Criteria7
- 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
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Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06847282