Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07473856
Eligibility Criteria:
Inclusion Criteria:
* Polyhandicap defined by:
* Causal brain injury or lesion occurring before the age of 3 years,
* Severe or profound intellectual disability according to DSM IV definition
* Motor disability: paraplegia/quadriplegia, hemiparesis, ataxia, and/or extrapyramidal motor disorders,
* Gross Motor Function Classification System (GMFCS) score of IV or V,
* Functional Independence Measure (FIM) score \< 55,
* Age: 1 to 16 years,
* Hospitalization of the patient with respiratory decompensation (RD),
* Informed consent from parents/legal guardians
Exclusion Criteria:
* Associated neuromuscular disease
* Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,
* Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,
* Contraindications for the use of the medical device:
* Pneumothorax,
* Hypotension or hemodynamic instability,
* Hemoptysis,
* Participation in another interventional study.
* Patients with tracheobronchial collapse during expiration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT07473856
Study Brief:
Protocol Section:
NCT07473856