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

NCT06798233 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-07

No results posted yet for this study

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

Conditions

  • Quadriplegia/Tetraplegia

Interventions

DIAGNOSTIC_TEST

Non-Ambulatory Hip Pain questionnaire

a new questionnaire for care givers to identify hip pain in pediatric patients with quadriplegia

Sponsors & Collaborators

  • IRCCS Fondazione Stella Maris

    collaborator OTHER

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-17
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798233 on ClinicalTrials.gov