Actively Recruiting

Phase Not Applicable
Age: 6Years - 12Years
All Genders
Healthy Volunteers
ID06190431

Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Children Aged 6 to 12 with and without Neuromuscular Diseases?

Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2026-06-01

40

Participants Needed

1

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether adding a coaching module with playful visual stimulation to physiotherapist guidance can improve how children learn to use a mechanical insufflation-exsufflation (MI-E) device. This study focuses on children aged 6 to 12, first including healthy children without lung or chronic diseases, then including children with neuromuscular diseases. MI-E is a technique recommended for clearing airways, especially useful in respiratory infections and postoperative care, but its learning process can be inconsistent without proper support. Participants will be randomly assigned to one of two groups: one receiving guidance from a physiotherapist plus the coaching module, and the other receiving guidance from a physiotherapist alone. Both groups will learn to use the MI-E device, and their learning times, cough flow rates, and synchronization with the device will be compared. The coaching module aims to make learning more effective and enjoyable. During the study, children will undergo learning sessions lasting up to 15 minutes, with evaluations of effectiveness at the session's end and again 24 hours later. Researchers will measure peak cough flow, ease of use, comfort using visual scales, number of cough sets, and the time to achieve quality coughs. The study will monitor safety by excluding children with certain conditions like pneumothorax or hemoptysis. The total study duration includes these assessments to understand the learning process better.

CONDITIONS

Brief Title

Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?

Who Can Participate

Age: 6Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 to 12 years
  • Consent given by child and two parents
  • Non-smoker
  • Speak and understand French
  • For healthy children: schooling in mainstream education
  • For children with neuromuscular diseases: able to perform the MI-E maneuver
  • Patient diagnosed with a neuromuscular disease (for second part)
Not Eligible

You will not qualify if you...

  • Congenital heart disease
  • Chronic lung disease
  • Immune deficiency
  • Neuromuscular disease or neurological disease (for healthy children group)
  • Multiple disabilities
  • History or signs of disease affecting lung function
  • Recent lung infection
  • Spinal or thoracic deformity
  • Hemodynamic instability
  • Current or recent pneumothorax
  • Hemoptysis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 15 minutes per learning session

Participants learn to use a mechanical in-exsufflation device with guidance from a physiotherapist, with or without an additional coaching module (playful visual stimulation).

1 learning session visit (in-person)

Follow-up

Duration - 1 day after the learning session

Participants return for a follow-up session approximately 24 hours after the learning session to assess effectiveness and ease of use.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Cliniques universitaires Saint Luc

Brussels, Brussels Capital, Belgium, 1200

Actively Recruiting

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Research Team

N

Nicolas Audag, PhD

G

Gregory Reychler, Pr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Prevalence of long-term mechanical insufflation-exsufflation in children with neurological conditions: a population-based study.

Brit Hov, Tiina Andersen, Michel Toussaint...

https://pubmed.ncbi.nlm.nih.gov/33393110