Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
RecruitingNot applicableNCT06798233
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The goal of this clinical trial is twofold: 1. to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently 2. to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia Researchers will : 1. involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire 2. assess construct validity and reliability of the questionnaire submitting it to 100 care givers of pediatric patients with quadriplegia, and comparing results with the Revised Face Legs Activity Cry and Consolability (r-FLACC) Scale assessed by the physiatrist during the visit Participants will: 1. as experts, firstly answer open questions on this topic, secondly evaluate each item of the new questionnaire by means of a 5-point Liekert scale 2. as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit
Study details
- Official title
- Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
- Conditions
- Quadriplegia/Tetraplegia
- Interventions
- Diagnostic test: Non-Ambulatory Hip Pain questionnaire
- Sponsor
- Azienda USL Reggio Emilia - IRCCS
- Collaborators
- IRCCS Fondazione Stella Maris
- Start date
- 2024-07-17
- Primary completion
- 2026-12
- Sex
- All
- Age range
- from 1 Year to 20 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * GMFCS IV-V * CFCS III-V * subscription of consent Exclusion Criteria: * care givers not speaking Italian or English
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06798233