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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Enrolling

Conditions: Neuromuscular Diseases; Cough; Airway Clearance Impairment

Treatments: Other: Learning the use of an in-exsufflation device with the guidance of a physiotherapist; Other: Using the coaching mode

Study type: Interventional

Funder types: Other

Identifiers

NCT06190431

MI-E coaching project

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

• Exclusion criteria

  • Hemodynamic instability
  • Current or recent pneumothorax
  • Hemoptysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Only physiotherapist guidance

Active Comparator group

Description:

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.

Treatment:

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

Physiotherapist guidance + coaching module

Active Comparator group

Description:

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.

Treatment:

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

Other: Using the coaching mode