An interventional study of Learning the use of an in-exsufflation device with the guidance of a physiotherapist and Using the coaching mode in Cough, Airway Clearance Impairment and Neuromuscular Diseases, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment
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.
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 350 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Part 1:
Inclusion criteria
Exclusion criteria
Part 2:
Inclusion criteria
Exclusion criteria
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.
Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist
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.
Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist · Other: Using the coaching mode
Learning to use an in-exsufflation device with the guidance of a physiotherapist
Learning the use of an in-exsufflation device using a coaching mode (playful visual stimulation) in addition to guidance of a physiotherapist
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)
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).
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)
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)
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)
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)
Visual analog scales (VAS) "comfort" (0-10)
Children will be assessed about the comfort of the procedure
Time frame: At the end of the learning session (max 15 minutes)
Visual analog scales (VAS) "comfort" (0-10)
Children will be assessed about the comfort of the procedure
Time frame: At the end of the session on the second day (24 hours after the learning session)
the number of sets (n)
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.
Time frame: At the end of the session on the second day (24 hours after the learning session)
the time (sec) needed by the subjects to achieve five Quality voluntary coughs
The investigators will measure the time (sec) needed by the subjects to achieve five Quality voluntary coughs one day after the learning session.
Time frame: At the end of the session on the second day (24 hours after the learning session)
Plan to share: No
Ran from Nov 2023 to primary completion in Jan 2024, 2 months.
Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's 2 months is below that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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