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:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06347432
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of severe CP (Gross Motor Function Classification System Level IV or V)
* Inability to functionally walk or functionally propel a manual wheelchair as assessed by the Principal Investigator a licensed physical therapist
* Demonstrate cause and effect skills in the IndieTrainer consistent with an Assessment of Learning Powered mobility use (ALP Assessment) Phase 4 or higher (i.e., understand that they are moving the IndieTrainer using the switch(es) or joystick) as assessed by the Principal Investigator, a licensed physical therapist.
* In addition, one parent/caregiver must be conversant in English and be able to provide their child's medical and health history and be willing to take on the parent participant role.
Exclusion Criteria:
* The inability to sit in their own manual wheelchair or adaptive stroller for 60 minutes (as this would preclude them safely using the IndieTrainer System for the 60-minute intervention sessions)
* Their manual wheelchair or adaptive stroller cannot be safely used with the IndieTrainer System
* They already have an individually prescribed power wheelchair
* If the Principal Investigator, a licensed physical therapist, determines that based on the child's medical and health history, that they cannot safely participate in power wheelchair skills training.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT06347432
Study Brief:
Protocol Section:
NCT06347432