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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT05495412
Eligibility Criteria:
Inclusion Criteria:
* Age: \>4 years up to \<16years
* Access to a caregiver in a position of main custody, capable of giving consent on the participant's behalf
* Access to a caregiver in a position of main custody who is able to consent to also participate in the study
* Accesses full time education
* Clinical diagnosis of neurodisability
* Physical impairment Gross Motor Function Classification Scale level 3-5 defined as: (Level 3): Walks with aids. Uses wheelchair for long distances; (Level 4): Self mobility with powered mobility; (Level 5): Severely limited, unable to lift head and trunk or use powered mobility due to other comorbidities like vision impairment.
* Swallow impairment Eating Drinking Ability Classification Scale Level 3-5, defined as (Level 3): Eats and drinks with some limitations to safety; maybe limitations to efficiency; (Level 4): Eats and drinks with significant limitations to safety; (Level 5): Unable to eat or drink safely - tube feeding may be considered to provide nutrition
* Symptoms of respiratory impairment, experienced at least once a week, defined as one or more of the following: (1) Noisy breathing (wheezy, gurgling, rattily etc.); (2) Weak/poor cough; (3) Difficulty clearing secretions AND a history of a chest infection in the past 3 years requiring medication.
* Risk assessment of safe access to educational setting
* Risk assessment of contraindications and care factors for rebound therapy
Exclusion Criteria:
* Children diagnosed with a progressive neurological presentation, including muscular dystrophies.
* Children with a confirmed absolute contraindication that will determine the participant unsuitable to participate in rebound therapy. These include: (1)Cranio-vertebral Instability (including Atlanto-Axial Instability \& Atlanto-Occipital Instability); (2) Detatching retina (s) or repaired retina (s); (3) Pregnancy; (4) Brittle bones; (5) Dwarfism; (6) Spinal rodding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
16 Years
Study:
NCT05495412
Study Brief:
Protocol Section:
NCT05495412