Caregiver questionnaire to find hip pain in non-ambulatory children with quadriplegia
Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 20 Years |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 2 sites (Pisa, Italy and 1 other locations) |
| Trial ID | NCT06798233 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pisa, Italy and 1 other locations
- IRCCS Fondazione Stella Maris — Pisa, Italy, Italy (Not_yet_recruiting)
- AziendaUSL IRCCS Reggio Emilia — Spilamberto, Modena, Italy (Recruiting)
Study contacts
- Study coordinator: Silvia Faccioli, MD PhD
- Email: silvia.faccioli@ausl.re.it
- Phone: +39 0522 296208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.