Quantitative Assessment of Orofacial Muscle Function in FSHD

University of Mons

Status: Completed

Conditions: Facioscapulohumeral Muscular Dystrophy

Treatments: Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds

Study type: Interventional

Funder types: Other

Identifiers

NCT06425445

P2024/031

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups

Affected participants

Experimental group

Treatment:

Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds

Healthy participants

Experimental group

Treatment:

Procedure: Measurement of maximal expiratory pressures during forced static expiratory maneuvers sustained over 5 seconds