RecruitingNot ApplicableNCT06190431

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


Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Enrollment

40 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria12

  • Part 1:
  • Age 6-12 (F/M)
  • Acceptance of consent (child + 2 parents)
  • Non-smoker
  • Speak and understand French
  • Schooling in mainstream education
  • 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 Criteria6

  • 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:
  • Hemodynamic instability
  • Current or recent pneumothorax
  • Hemoptysis

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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


Locations(1)

Cliniques universitaires Saint Luc

Brussels, Brussels Capital, Belgium

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NCT06190431


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