NCT06798233 Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
| NCT ID | NCT06798233 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda USL Reggio Emilia - IRCCS |
| Condition | Quadriplegia/Tetraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-07-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * GMFCS IV-V * CFCS III-V * subscription of consent Exclusion Criteria: * care givers not speaking Italian or English
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06798233 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 20 Years, studying Quadriplegia/Tetraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06798233 currently recruiting?
Yes, NCT06798233 is actively recruiting participants. Contact the research team at silvia.faccioli@ausl.re.it for enrollment information.
Where is the NCT06798233 trial being conducted?
This trial is being conducted at Pisa, Italy, Spilamberto, Italy.
Who is sponsoring the NCT06798233 clinical trial?
NCT06798233 is sponsored by Azienda USL Reggio Emilia - IRCCS. The trial plans to enroll 100 participants.