Improving learning of a cough assistance technique in children
Does the Coaching Function Improve the Learning of Mechanical In-exsufflation (MI-E) in Paediatric Subjects?
This study is testing if a fun coaching program can help children, both healthy and those with neuromuscular diseases, learn a special cough technique better than just regular guidance from a physiotherapist.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06190431 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether a coaching module using playful visual stimulation can enhance the learning and effectiveness of the mechanical insufflation-exsufflation (MI-E) technique in children. The trial will be conducted in two phases: the first will involve healthy children aged 6 to 12, while the second will focus on children with neuromuscular diseases. Participants will be randomly assigned to receive either physiotherapist guidance alone or guidance combined with the coaching module. The goal is to determine if the coaching module leads to better learning outcomes and compliance with the MI-E technique.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 12 who can understand French and have either no significant health issues or have a neuromuscular disease.
Not a fit: Patients with hemodynamic instability, recent pneumothorax, or hemoptysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve airway clearance techniques in pediatric patients, enhancing their respiratory health.
How similar studies have performed: While the use of MI-E is well-documented, the specific approach of using a coaching module in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Brussels
- Cliniques universitaires Saint Luc — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Nicolas Audag, PhD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Nicolas Audag, PhD
- Email: nicolas.audag@saintluc.uclouvain.be
- Phone: 027641621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.