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NCT Number: NCT06190431

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

The use of mechanical insufflation-exsufflation (MI-E) in children with neuromuscular diseases (NMD) is recommended by international guidelines and societies and well documented. Many authors have shown that MI-E is safe and effective for airway clearance and has a significant benefit in reducing the duration of the airway clearance session in children with respiratory infections and atelectasis or in the postoperative period. However, its use in paediatrics is still poorly supervised and learning the technique is too often therapist- and/or patient-dependent. The use of a protocol or means of help to guide the initiation and learning of MI-E would allow better use, better adaptation of the settings and potentially better compliance with the treatment. The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone.This randomized controlled study will first include healthy children, aged 6 to 12 years, with no history or recent respiratory infection affecting lung function or other chronic diseases. In a second phase, the investigators will test the use of the learning process in children with neuromuscular diseases. The investigators hope that the results of this study will provide a better framework for the learning and effectiveness of MI-E. Furthermore, if the results are positive, this will allow better support for the use of MI-E in chronic treatments and help to ensure that this costly treatment for hospitals and public health is used efficiently.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint Luc

Brussels, Brussels Capital, 1200, Belgium

Location status: Recruiting

Location contact

Nicolas Audag, Phd

CONTACT

[email protected]

00327641621

About this study

RATIONALE In the first part, the population will be composed of healthy children, in the second part, the investigators will include children with neuromuscular diseases. The two parts will follow the same process. The hypothesis is that the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the MI-E compared to guidance alone. The MI-E technique does not represent any documented risk in its use nor in its indication if the contraindications are respected (non-drained pneumothorax, hemoptysis and hemodynamic instability). Coaching modules (playful visual stimulation) have recently become available on MI-E devices. This experiment will allow us to judge their usefulness in teaching the use of MI-E in paediatric patients.

OBJECTIVES The aim of this study is to test whether the use of a coaching module (playful visual stimulation) in addition to guidance by a physiotherapist improves the learning and effectiveness of the technique compared to guidance alone. This randomized controlled study will first include healthy children, aged 6 to 12 years. In a second phase, the investigators will test the use in children with neuromuscular diseases. For the process (common for the two parts), eligible subjects will be invited to perform, depending on randomization at the intervention 1 (physiotherapist guidance + coaching module) or the intervention 2 (physiotherapist guidance). The learning times, the coughing expiratory flow rate achieved and the synchronization between the subject and the machine will be compared between the two processes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Part 1:

  • Inclusion criteria
  • Age 6-12 (F/M)
  • Acceptance of consent (child + 2 parents)
  • Non-smoker
  • Speak and understand French
  • Schooling in mainstream education
  • Exclusion criteria
  • Comorbidities: congenital heart disease, chronic lung disease, immune deficiency, neuromuscular disease, neurological disease or multiple disabilities
  • History or clinical signs of disease affecting lung function, recent lung infection, spinal or thoracic deformity.

Part 2:

  • Inclusion criteria
  • Age 6-12 (F/M)
  • Acceptance of consent (child + 2 parents)
  • Non-smoker
  • Speak and understand French
  • Patient with a neuromuscular disease
  • Able to perform the MI-E maneuver
  • Exclusion criteria
  • Hemodynamic instability
  • Current or recent pneumothorax
  • Hemoptysis

Treatment and study plan

Learning the use of an in-exsufflation device with the guidance of a physiotherapist

Other

Learning to use an in-exsufflation device with the guidance of a physiotherapist

Using the coaching mode

Other

Learning the use of an in-exsufflation device using a coaching mode (playful visual stimulation) in addition to guidance of a physiotherapist

Primary outcomes

  1. Effectiveness

    Time frame: A the end of the learning session (after maximum 15 minutes)

    The investigators will measure the number of sets (n) needed by the subjects to achieve five quality voluntary coughs during the learning session.

  2. Effectiveness

    Time frame: A the end of the learning (after maximum 15 minutes).

    The investigators will measure the time needed (sec) by the subjects to achieve five quality voluntary coughs during the learning session.

Secondary outcomes

  1. Peak cough flow measured with the device (L/min)

    Time frame: During the learning session (max 15 minutes)

    The peak cough flow reached with the In-exsufflation device will be reported

  2. Peak cough flow measured with the device (L/min)

    Time frame: During the session on the second day (24 hours after the learning session)

    The peak cough flow reached with the In-exsufflation device will be reported

  3. Visual analog scales (VAS) "ease of use" (0-10)

    Time frame: At the end of the learning session (max 15 minutes)

    Children will be assessed about the ease of the learning

  4. Visual analog scales (VAS) "ease of use" (0-10)

    Time frame: At the end of the session on the second day (24 hours after the learning session)

    Children will be assessed about the ease of the learning

  5. Visual analog scales (VAS) "comfort" (0-10)

    Time frame: At the end of the learning session (max 15 minutes)

    Children will be assessed about the comfort of the procedure

  6. Visual analog scales (VAS) "comfort" (0-10)

    Time frame: At the end of the session on the second day (24 hours after the learning session)

    Children will be assessed about the comfort of the procedure

  7. the number of sets (n)

    Time frame: At the end of the session on the second day (24 hours after the learning session)

    The investigators will measure the number of sets (n) needed by the subjects to achieve five Quality voluntary coughs one day after the first session.

  8. the time (sec) needed by the subjects to achieve five Quality voluntary coughs

    Time frame: At the end of the session on the second day (24 hours after the learning session)

    The investigators will measure the time (sec) needed by the subjects to achieve five Quality voluntary coughs one day after the learning session.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Reychler, Pr

CONTACT

[email protected]

027642316

Nicolas Audag, PhD

CONTACT

[email protected]

027641621

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: MI-Ecoaching

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jan 5, 2024
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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