Actively Recruiting

Phase Not Applicable
Age: 1Year - 20Years
All Genders
NCT06798233

Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire

Led by Azienda USL Reggio Emilia - IRCCS · Updated on 2026-05-07

100

Participants Needed

2

Research Sites

123 weeks

Total Duration

On this page

Sponsors

A

Azienda USL Reggio Emilia - IRCCS

Lead Sponsor

I

IRCCS Fondazione Stella Maris

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire

Who Can Participate

Age: 1Year - 20Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Quadriplegia classified as GMFCS level IV or V
  • Communication abilities classified as CFCS level III to V
  • Signed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Caregivers who do not speak Italian or English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

IRCCS Fondazione Stella Maris

Pisa, Italy, Italy, 56128

Not Yet Recruiting

2

AziendaUSL IRCCS Reggio Emilia

Spilamberto, Modena, Italy, 41057

Actively Recruiting

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Research Team

S

Silvia Faccioli, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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