Elective lower limb paediatric orthopaedic surgery Surgery
Conditions
Interventions
The PREPARE KIDS study is a research study to find out whether giving children a prehabilitation session before planned lower limb surgery, alongside their usual NHS care (Group 1), helps them recover
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
5 Years to 14 Years
Inclusion criteria
Inclusion criteria: Main Study: 1. Aged 5-14 years (i.e., from their 5th birthday up to, but not including, their 15th birthday at the time of consent) 2. Scheduled for elective lower-limb surgery (hips to toes, excluding toenail surgery) Process Evaluation: Children: 1. Currently enrolled in the main study 2. Parent/guardian has provided informed consent for the child’s participation in the interview study 3. Child is willing and able to participate in the interview Parent/Guardian: 1. Parent/Guardian of a participant enrolled in the main study 2. Has provided consent to be contacted regarding interview study 3. Willing and able to give informed consent for participation in the interview study Site Clinical/Research Staff: 1. Clinical and research staff participating in the PREPARE KIDS study 2. Willing and able to give informed consent for participation in the interview study
Exclusion criteria
Exclusion criteria: Main Study: 1. The child is currently receiving a physiotherapy programme which replicates the content of PREPARE KIDS 2. The child and/or their parent(s)/guardian(s) are unable to comply with assessment procedures 3. Previous participation in PREPARE KIDS study Process Evaluation: Children: 1. Withdrawn from the main study Parent/Guardian: 1. No longer acting as parent/guardian of a participant enrolled in the main study 2. Child withdrawn from the main study Site Clinical/Research Staff: 1. No longer involved in the conduct of the main study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional mobility is measured using the PROMIS Mobility Score for Children (MSC), Parent Proxy Version, at 2 weeks postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional mobility is measured using the PROMIS Mobility Score for Children (MSC), Parent Proxy Version, at baseline, 6 weeks, and 12 weeks postoperatively 2. Functional mobility is measured using the PROMIS Mobility Score for Children (MSC), Parent Proxy Version and Self-Reported Version (=8 years), at baseline, 2 weeks, 6 weeks, and 12 weeks postoperatively 3. Pain is measured using the Wong-Baker FACES Scale (WBS) at baseline, 2 weeks, 6 weeks, and 12 weeks postoperatively 4. Health-related quality of life is measured using the EQ-5D-Y-3L (self-reported for children =8 years or parent proxy version for children <8 years) at baseline, 2 weeks, 6 weeks, and 12 weeks postoperatively 5. Carer health and wellbeing is measured using the EQ-HWB-9 at baseline and 12 weeks postoperatively 6. Parental satisfaction is measured using a Parental Satisfaction Questionnaire (Likert scale) at 12 weeks postoperatively 7. School attendance is measured using an Educational Participation Questionnaire at 12 weeks postoperatively 8. Length of hospital stay is measured using the number of postoperative nights spent in hospital at 12 weeks postoperatively 9. Surgical complications are measured using the Modified Clavien–Dindo Classification System at 12 weeks postoperatively 10. Healthcare resource use is measured using a study-specific questionnaire and review of medical records at 12 weeks postoperatively 11. Use of additional childcare services measured using a study-specific questionnaire at 12 weeks postoperatively 12. Use of additional carer time off work measured using a study-specific questionnaire at 12 weeks postoperatively | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactMegan;PREPARE KIDS Stone;Team
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Outcome results
None listed