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NCT07164937: FSH-3DGait
Imaging and Gait Analysis in FSHD Patients
trial in FSHD - Facioscapulohumeral Muscular Dystrophy in 40 participants. Enrolling by invitation.
30 November 2024
Quick facts
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 30 November 2024 |
| Primary completion | 30 November 2024 |
| Estimated completion | 30 November 2026 |
| Sites | 1 location across Italy |
Conditions studied
- FSHD - Facioscapulohumeral Muscular Dystrophy — all drugs for FSHD - Facioscapulohumeral Muscular Dystrophy →
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Who can join
18 and older, any sex, with FSHD - Facioscapulohumeral Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Facioscapulohumeral muscular dystrophy (FSHD) is a common genetic muscle disorder characterized by progressive and often asymmetric muscle weakness, with high variability in clinical severity and disease progression. This study aims to integrate advanced imaging and motion analysis technologies to comprehensively evaluate the impact of FSHD on muscle degeneration and motor functionality. The primary objective is to characterize the distribution and severity of muscle degeneration using magnetic resonance imaging (MRI) and correlate these findings with motor functionality profiles in a cohort of FSHD patients. Secondary objectives include: Describing gait and posture through the analysis of functional parameters using 3D-motion capture technologies. Quantifying changes in gait and posture parameters before and after personalized orthopedic interventions, assessed with functional clinical scales and 3D-motion capture analysis. This single-center, observational study will recruit 40 genetically confirmed FSHD patients from routine clinical follow-ups at the Policlinico Gemelli. Patients will undergo MRI to assess the degree of muscle fatty replacement (T1-score) and 3D Gait Analysis to capture biomechanical parameters such as kinematics, ground reaction forces, and muscle activation. Functional assessments will include tests like the Six-Minute Walk Test (6MWT) and Timed Up \& Go Test (TUG), alongside standardized scales for balance, fatigue, pain, and quality of life. The study seeks to identify novel clinical and biomechanical outcome measures that can stratify FSHD patients and evaluate therapeutic interventions. By correlating MRI patterns with motor deficits and analyzing the impact of orthopedic devices, the study aims to inform personalized rehabilitation strategies and support the design of clinical trials.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT07164937
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Related trials
Other recruiting trials for FSHD - Facioscapulohumeral Muscular Dystrophy
Currently open trials in the same condition.
- NCT06911190 — Ten Year Follow-up in FSHD: the FOCUS 3 Study · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07164937 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Last refreshed: 10 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07164937.
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