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| Name | Class |
|---|---|
| BC Children's Hospital Research Institute | OTHER |
| Canuck Place Children's Hospice Research Initiative | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | The study participants are the children with severe neurological impairment (SNI) undergoing major (>90 minute procedure) orthopedic surgery to manage musculoskeletal pathology between the ages of 5 and 18 at the time of surgery and their parent/caregiver. Blood will be collected from the child with SNI (at 6 different time points: at the pre-operative assessment, at the time of surgery, 12-24 hours post-operative, 1-2 weeks post-operative, 6 weeks post-operative and 6 months post-operative). The parent/caregiver of the child will be completing the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire and answer two supplemental questions (at the pre-operative visit, at a 6-weeks post-operative visit and a 6-month post-operative visit). At the initial pre-operative study visit, the parent/caregiver will also complete a demographics form in which demographic information of the child and the parent/caregiver will be collected. | ||
| Control Participants | The control participants group will consist of neurotypically developing children undergoing spine surgery for scoliosis between the ages of 5 and 18 at the time of their surgical procedure. The child or the parent/caregiver of the child, depending on the age of the child, will complete a demographic form and then have blood samples collected at 3 timepoints (during surgery, 12-24 hours post-operative and 6 months post-operative) |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the feasibility of the study protocol for children and their families living with severe neurological impairment. | Feasibility will be assessed using consent rate (the overall average consent rate of children/month), protocol delivery (the percent of on/off protocol children) and outcome completion (the percent of children with complete outcome measures). | From enrollment to the end-of-study interview approximately 6 months after surgery. |
| To evaluate the acceptability of the study protocol for children and their families living with severe neurological impairment. | Acceptability will be evaluated using end-of-study interviews with caregivers to assess the ease and utility of participating in the study as it relates to our methods and data collection. | From enrollment to the end-of-study interview approximately 6 months after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the function in children with SNI, including exploring patterns in specific domains of gain/loss, to explore patterns of recovery in children with severe neurological impairment (SNI) during the peri-operative period. | The functional changes of children with SNI over the perioperative period will be assessed using the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire. The CPCHILD Questionnaire is used to assess the effectiveness of interventions aimed at improving and preserving outcomes for children aged 5-18 years of age with severe disabilities, based on caregivers' perspectives and thus, can be used to track functional changes of children over time. Parents/caregivers will also be asked a supplemental question to provide further insight into other areas of function that were not described by CPCHILD. |
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Inclusion Criteria for Study Participants
Exclusion Criteria for Study Participants:
Inclusion Criteria for Control Group Participants:
Exclusion Criteria for Control Group Participants:
1) Non-English-speaking parents/caregivers
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The BC Children's Hospital Orthopedic Clinic (Hip and Spine) will serve as the main recruitment site.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Mette Hermansen | Contact | (604) 875 2000 | 6909 | ahermansen@bcchr.ca |
| Elaha Niazi | Contact | elaha.niazi@bcchr.ca |
| Name | Affiliation | Role |
|---|---|---|
| Hal Siden | Department of Pediatrics, UBC | Principal Investigator |
| Liisa Holsti | Department of Occupational Science and Occupational Therapy, UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital Research Institute | Recruiting | Vancouver | British Columbia | V5Z 4H4 | Canada |
In this small study patient deidentification is a priority and IPD may be a problem for confidentiality.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 16, 2025 | Jul 30, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
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The investigators will be collecting blood samples from study participants at 6 time points and control participants at 3 time points. A 3 mL aliquot of blood will be collected from participants, via venipuncture at timepoints 1, 3, 4, 5, and 6; and via peripheral line at timepoint 2 and 3 (when venipuncture is not conducted). Additionally, 50uL of blood will be collected from study participants through capillary sampling at timepoint 1.
Following collection, the samples will be transferred to heparin-coated collection tubes, after which they will be transported to the BC Children's Hospital BioBank for storage.
| From enrollment to 6 months following surgery. |
| Assessing the quality of life in children with SNI and their families, to explore patterns of recovery in children with severe neurological impairment (SNI) during the peri-operative period. | This objective will also be assessed using the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire. The CPCHILD Questionnaire is used to assess the effectiveness of interventions aimed at improving and preserving outcomes for children aged 5-18 years of age with severe disabilities, based on caregivers' perspectives. Within the CPCHILD parents/caregivers are asked questions about their child's quality of life and parents/caregivers will also be asked to answer a supplemental question to provide further insight into the quality of life of caregivers. | From enrollment to 6 months following surgery. |
| D010335 | Pathologic Processes |