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New caregiver questionnaire to assess hip pain in children with quadriplegia

Develops and tests a caregiver questionnaire on hip pain in children with quadriplegia.

Key facts

Who runs it
Azienda USL Reggio Emilia - IRCCS
Where
Italy2 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
Status
Recruiting
People taking part
100 people, planned
Started
17 Jul 2024
Expected to end
Dec 2026
Type of study
Interventional
Treatments tested
  • Non-Ambulatory Hip Pain questionnaire
Record updated
7 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people with quadriplegia (all four limbs affected) who cannot easily move or communicate. Their caregivers fill out a new questionnaire about hip pain.

Age
1 Year to 20 Years
Sex
All sexes can join
Disease stage
Quadriplegia with movement level GMFCS IV-V (very limited or no walking) and communication level CFCS III-V (limited communication).

Main reasons for not taking part

  • Caregivers who do not speak Italian or English cannot join
  • People who do not sign the consent form cannot join

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • GMFCS IV-V
  • CFCS III-V
  • subscription of consent

Who cannot take part

  • care givers not speaking Italian or English

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 1 and 20 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this clinical trial is twofold:

Read full original descriptionShow less

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

The group in the trial

  • patients with quadriplegiaTreatment being tested

    Care givers of patients with quadriplegia will fill out a questionnaire aimed at identifying hip pain

    Treatment: Non-Ambulatory Hip Pain questionnaire

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
Plain-language title
New caregiver questionnaire to assess hip pain in children with quadriplegiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06798233, who can take part
Record updated
7 May 2026