Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- Caregivers who do not speak Italian or English
AI-Screening
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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
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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