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:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT07121660
Eligibility Criteria:
Inclusion Criteria for Study Participants
1. Children with severe neurological impairment (SNI), including Gross Motor Function Classification System (GMFCS) levels II, III, IV and V and Communication Function Classification System (CFCS) levels II, III, IV and V, and;
2. undergoing major orthopaedic surgical management of musculoskeletal pathology (spine or hip; major defined as \>90 minute procedure with skin-to-skin contact) at the BC Children's Hospital and;
3. between 5 and 18 years at the time of their surgical procedure
Exclusion Criteria for Study Participants:
1. GMFCS level = I and CFCS level = I
2. Non-English-speaking Parents/Caregivers
Inclusion Criteria for Control Group Participants:
1. Neurotypically developing children (GMFCS I and CFCS I) and;
2. undergoing major orthopaedic surgical management of musculoskeletal pathology (spine or hip; major defined as \>90 minute procedure with skin-to-skin contact) at the BC Children's Hospital and;
3. Between 5 and 18 years of age at the time of their surgical procedure
Exclusion Criteria for Control Group Participants:
1\) Non-English-speaking parents/caregivers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT07121660
Study Brief:
Protocol Section:
NCT07121660