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

May 4, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with quadriplegia have complex health and care needs: multimorbidity increases mortality, worsens functioning and participation (according to the ICF model) and negatively affects quality of life. One of the main problems that is difficult to identify early is undoubtedly pain, complicated by the many potential sources of pain and the different levels of intellectual and communicative disability of these patients. Although pain is a frequent concern for these patients and their families, as it greatly interferes with the daily activities and quality of life of all members of the household, it is very often underestimated, consequently little treated and little studied. In the pediatric population, the majority of patients with these characteristics have a diagnosis of Cerebral Palsy (CP): 26% have quadriplegia, classifiable as level IV-V of the Gross Motor Function Classification System (GMFCS). In children with CP, pain is a secondary problem to primary disorders, but with a strongly negative impact on the overall picture, both for the strictly clinical aspects and for the deterioration of quality of life. More than 90% of children with CP between 5 and 18 years of age report experiences of pain within the 1st year (48% ambulatory patients, 79% non-ambulatory patients). A previous study on a sample of 101 parents of children with nonverbal CP, between 2 and 20 years old, report that 65% reported painful experiences in the last 4 weeks (for 17% the pain is intense, for 28% it is daily). Among the most common causes of chronic pain is described pain of musculoskeletal origin, often caused by joint misalignments, increased muscle tone and osteoporosis. Hip dislocation and associated pain are certainly among the main topics of rehabilitation relevance. According to literature data, the specific prevalence of hip pain ranges from 9.6% to 27% in non-ambulatory children or adolescents with CP. Hip pain increases with age, GMFCS level, and degree of dislocation. To monitor and detect hip migration early, as well as to prevent pain, several countries have developed specific hip surveillance programs for children with CP. Population-based registry studies have reported a prevalence of hip pain of 7.9% in patients with IV GMFCS and 20.5% among patients with IV GMFCS in the 4-16 age group, and an overall prevalence of 72% among adolescents and young adults with PC. The highest prevalence of hip pain is found in patients over 11 years of age. In non-verbal children or children with limited verbal and cognitive abilities, the description of pain is entrusted to parents and/or caregivers (observational/proxy methods), who know and interpret the typical behavioral response of their child. Therefore, in addition to a detailed medical history and physical examination, the importance of recognizing painful behaviors and the use of pain hetero-assessment scales was highlighted. According to a recent systematic review the parent or caregiver report can be used as an alternative for pain assessment in children with or at high risk of CP. The NICE guidelines for the identification of pain and the assessment of its intensity in children and adolescents with communication difficulties suggest the use of the Paediatric Pain Profile (PPP) or the Non-communicating Children's Pain Checklist - postoperative version (NCCPC-R). However, none of these tools are specific to CP patients. In 2004 the Pain Assessment Instrument for Cerebral Palsy (PAICP) was presented, a questionnaire dedicated to patients with severe CP, which uses Alternative Augmentative Communication images to identify potentially painful situations associated with the Faces Pain Scale to identify pain intensity. This tool, however, is not specific for hip pain and, moreover, implies a sufficient cognitive level to use the aforementioned communication tools. Based on our knowledge, there are no new studies that point to specific and/or effective tools for the identification of hip pain in quadriplegic pediatric patients. Therefore, to date, there is no specific assessment tool available for this population that investigates the presence and characteristics of hip pain. The aim of the present study is to develop and validate a questionnaire to be administered to caregivers, that can assist healthcare professionals in the identification of hip pain in pediatric patients with quadriplegia.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Italy
      • Pisa, Italy, Italy, 56128
        • Not yet recruiting
        • IRCCS Fondazione Stella Maris
    • Modena
      • Spilamberto, Modena, Italy, 41057
        • Recruiting
        • AziendaUSL IRCCS Reggio Emilia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • care givers not speaking Italian or English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients with quadriplegia
Care givers of patients with quadriplegia will fill out a questionnaire aimed at identifying hip pain
Diagnostic test: Non-Ambulatory Hip Pain questionnaire
a new questionnaire for care givers to identify hip pain in pediatric patients with quadriplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
Time Frame: The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
The questionnaire developed by means of the Delphi Method will be submitted to a group of 8-10 experts. They will evaluate each item and attribute one of the following judgments "essential", "usefull but not essential" or "unnecessary". The content validity ratio (CVR) for each item and the overall content validity index (CVI) will be calculated. The CVI is expected to be > 0.75 for eight-expert group or > 0.62 for 10-expert group. In case of lower values the items with the lowest CVR values will require to be revised, considering the experts' comments. The minimum and maximum values of the NAHPq are to be defined during the development Delphi phase; higher values will represent higher pain.
The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
Internal reliability of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
Time Frame: The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.
After validity assessment, the questionnaire will be submitted to 100 caregivers of quadriplegic non-communicative patients aged 1-20 years. The Pearson's coefficient will be used to assess the inter-item correlation and the item-to-total correlation. The Cronbach's alpha will be calculated to measure the internal consistency.
The NAHPq is filled out by the caregiver within 2 weeks after the recruitment visit, during which the hip pain is assessed by the physiatrist with the r-FLACC scale.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Criterion validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
Time Frame: The hip pain will be assessed by the physiatrist with the r-FLACC scale during the visit; by the care giver with the NAHPq within 2 weeks after the visit.
Measure of the degree of reproducibility of the pain assessment with the questionnaire completed by the families compared to the clinical assessment of pain performed by the clinician during the visit by means of the Revised Face Legs Activity Cry and Consolability (r-FLACC) Scale (minimum value 0, maximum value 10; higher scores mean a worse outcome). The agreement between the NAHPq and the FLACC scale will be measured by means of Cohen's kappa coefficient or another correlation coefficient.
The hip pain will be assessed by the physiatrist with the r-FLACC scale during the visit; by the care giver with the NAHPq within 2 weeks after the visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Collaborators

IRCCS Fondazione Stella Maris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 254/2024/SPER/AUSLRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD after conclusion of this study will be made available by the authors upon reasonable request.The data are not publicly available due to restrictions (e.g., their containing information that could compromise the privacy of research participants)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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