Quantitative Assessment of Orofacial Muscle Function in FSHD

May 17, 2024 updated by: Alexandre Legrand, University of Mons

Development of a New Clinical Tool for the Assessment of Orofacial Muscles in Patients Affected by Facioscapulohumeral Muscular Dystrophy: a Preliminary Study.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator)
  • Phone Number: 0032485114738
  • Email: 535678@umons.ac.be

Study Contact Backup

Study Locations

  • Belgium
    • Hainaut
      • Mons, Hainaut, Belgium, 7000
        • Recruiting
        • University of Mons
        • Contact:
          • Eliot Rudy Mbolo Ebubu (PhD candidate, MD, study investigator)
          • Phone Number: 0032485114738
          • Email: 535678@umons.ac.be
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy participants
Procedure: 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
Experimental: Affected participants
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pressure drop
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mons

Investigators

  • Principal Investigator: Alexandre Legrand (PhD, MD, principal investigator), University of Mons

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2024/031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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