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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

* Age 6-12 (F/M)

Acceptance of consent (child + 2 parents)

Non-smoker

Speak and understand French

Disqualifiers

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.

Inclusion criteria

Age 6-12 (F/M)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

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

  • Using the coaching mode

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Only physiotherapist guidanceActive comparator 1 intervention
Group B: Physiotherapist guidance + coaching moduleActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Effectiveness

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

Time frame
A the end of the learning session (after maximum 15 minutes)
2

Effectiveness

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

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

Secondary outcomes

1

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

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

Time frame
During the learning session (max 15 minutes)
2

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

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

Time frame
During the session on the second day (24 hours after the learning session)
3

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

Children will be assessed about the ease of the learning

Time frame
At the end of the learning session (max 15 minutes)
4

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

Children will be assessed about the ease of the learning

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

Other outcomes

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