Caregiver questionnaire to find hip pain in non-ambulatory children with quadriplegia
Official title: Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
Run by Azienda USL Reggio Emilia - IRCCS · NCT06798233 · Data updated 2026-11-12
This project will test a new caregiver questionnaire to help identify hip pain in children and teens with quadriplegia who cannot communicate it themselves.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 20 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 2 sites (Pisa, Italy and 1 other locations) |
| Status | Recruiting |
| Started | July 17, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT06798233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are non-ambulatory pediatric patients with quadriplegia (GMFCS IV–V) who have limited communication (CFCS III–V) and whose caregivers speak Italian or English.
✕Probably not a fit
Children who can self-report pain, ambulatory patients, or those whose caregivers do not speak Italian or English are unlikely to benefit directly from this specific questionnaire.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will use a Delphi process with 10 experts (eight multiprofessional clinicians and two parents) to generate and refine questionnaire items for caregiver reporting of hip pain in non-ambulatory pediatric quadriplegic patients. The resulting tool will be administered to 100 caregivers within two weeks after a clinic visit and compared to the physiatrist's r-FLACC ratings. Psychometric analyses will examine construct validity and reliability of the new questionnaire. Participants are selected by motor and communication function (GMFCS IV–V and CFCS III–V) and caregivers must speak Italian or English.
Why it matters
Potential benefit: If successful, the questionnaire could help caregivers and clinicians detect and measure hip pain earlier and more reliably, enabling better pain management and improved quality of life.
How similar studies have gone: Existing tools like the r-FLACC have been used for nonverbal children, but caregiver-specific, validated hip-pain questionnaires for non-ambulatory quadriplegic pediatric patients are limited, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * GMFCS IV-V * CFCS III-V * subscription of consent Exclusion Criteria: * care givers not speaking Italian or English
Where it's running
-
AziendaUSL IRCCS Reggio Emilia
Spilamberto, Modena, Italy Recruiting -
IRCCS Fondazione Stella Maris
Pisa, Italy, Italy Not yet recruiting
Study contacts
- Study coordinator: Silvia Faccioli, MD PhD
- Email: silvia.faccioli@ausl.re.it
- Phone: +39 0522 296208
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.