Quantitative Assessment of Orofacial Muscle Function in FSHD

NCT ID: NCT06425445

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2025-01-31

Brief Summary

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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

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Conditions

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Facioscapulohumeral Muscular Dystrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Affected participants

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Participants perform forced static expiratory maneuvers sustained over a five second period

Healthy participants

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Participants perform forced static expiratory maneuvers sustained over a five second period

Interventions

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

Participants perform forced static expiratory maneuvers sustained over a five second period

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Mons

OTHER

Sponsor Role lead

Responsible Party

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Alexandre Legrand

Professor and Dean of the Faculty of Medicine and Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandre Legrand (PhD, MD, principal investigator)

Role: PRINCIPAL_INVESTIGATOR

University of Mons

Locations

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University of Mons

Mons, Hainaut, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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P2024/031

Identifier Type: -

Identifier Source: org_study_id

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