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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06190431
Acronym
MI-Ecoaching
Enrollment
40
Registered
2024-01-05
Start date
2023-11-20
Completion date
2026-05-31
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Clearance Impairment, Cough, Neuromuscular Diseases

Keywords

Mechanical In-Exsufflation, Coaching, Cough Assistance, Pediatric

Brief summary

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.

Detailed description

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.

Interventions

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

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

OTHERUsing the coaching mode

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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

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 *

Design outcomes

Primary

MeasureTime frameDescription
EffectivenessA 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.

Secondary

MeasureTime frameDescription
Peak cough flow measured with the device (L/min)During the learning session (max 15 minutes)The peak cough flow reached with the In-exsufflation device will be reported
Visual analog scales (VAS) "ease of use" (0-10)At the end of the learning session (max 15 minutes)Children will be assessed about the ease of the learning
Visual analog scales (VAS) "comfort" (0-10)At the end of the learning session (max 15 minutes)Children will be assessed about the comfort of the procedure
the number of sets (n)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.
the time (sec) needed by the subjects to achieve five Quality voluntary coughsAt 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.

Countries

Belgium

Contacts

CONTACTNicolas Audag, PhD
nicolas.audag@saintluc.uclouvain.be027641621
CONTACTGregory Reychler, Pr
gregory.reychler@saintluc.uclouvain.be027642316
PRINCIPAL_INVESTIGATORNicolas Audag, PhD

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 2, 2026