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Post-operative Changes Study

Recruitingn/aAges 5 Years - 18 YearsAllUniversity of British Columbia
NCT07121660 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational pilot study is to evaluate the feasibility and acceptability of the protocol to explore the functional post-operative trajectory in a developmentally and neurologically impaired pediatric population. The main objectives of the study are: * Objective 1: To evaluate the feasibility and acceptability of the study protocol for children and families living with severe neurological impairment (SNI). To evaluate feasibility the investigators will assess consent rate, protocol delivery and outcome completion. To evaluate acceptability, the investigators will conduct end-of-study interviews with caregivers to assess outcomes related to the ease and utility of participating in the study, including the methods of data collection. * Objective 2: To explore patterns of recovery in children with SNI during the peri-operative period. To do this, the investigators will b

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
BC Children's Hospital Research Institute
Vancouver, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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