Post-operative recovery in children with severe neurological impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational pilot conducted at BC Children's Hospital that follows children with severe neurological impairment through the peri-operative period after major spine or hip surgery. The team will record feasibility metrics such as consent rate, protocol delivery, and completion of outcome measures, and will conduct end-of-study interviews with caregivers to judge acceptability. Functional status and quality of life measures will be collected alongside a neurotypically developing control group undergoing similar surgeries to explore patterns of recovery. The protocol is non-interventional and focuses on measurement and caregiver experience rather than changing clinical care.

Why it matters

Who can join: the full rules

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

Where it's running

• BC Children's Hospital Research Institute
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Hal Siden — Department of Pediatrics, UBC
• Study coordinator: Anne-Mette Hermansen
• Email: ahermansen@bcchr.ca
• Phone: (604) 875 2000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.