Quantitative Assessment of Orofacial Muscle Function in FSHD
Not Applicable
Completed
- Conditions
- Facioscapulohumeral Muscular Dystrophy
- Registration Number
- NCT06425445
- Lead Sponsor
- University of Mons
- Brief Summary
The goal of this study is to validate a new method for the assessment of orofacial muscles in FSHD affected individuals, using maximal expiratory pressures (MEPs).
Our hypothesis is the following:
- The pressure drop observed when using circular mouthpieces (versus ovoid mouthpieces) is a reflection of orofacial dysfunction in FSHD affected individuals
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Genetic diagnosis of FSHD type 1 and/or type 2
Exclusion Criteria
- Pregnant women
- Presence of other associated neuromuscular conditions
- Any unstable interfering clinical situation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The pressure drop The pressure drop will be assessed for each study participant at visit 1 and subsequently at visit 2 (3 months later). The measurements as such, should take about 30 minutes for each participant The pressure drop (PD) is defined as the pressure difference between a reference ovoid-shaped mouthpiece and variously-sized circular mouthpieces, divided by the reference pressure. It is a relative value that is expected to reflect the magnitude of orofacial muscle dysfunction in FSHD affected individuals.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Mons
🇧🇪Mons, Hainaut, Belgium
University of Mons🇧🇪Mons, Hainaut, Belgium