Official Title

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

Brief 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

Sponsor

Azienda USL Reggio Emilia - IRCCS

Recruitment Status

RECRUITING

Study Objective

DIAGNOSTIC

ClinicalTrials.gov ID

NCT06798233

Additional Identification number

Last Update Posted

2025-06-11

Study Completion (Actual)

2026-12

Study Record Versions

Contacts and Locations

facility: AziendaUSL IRCCS Reggio Emilia
status: RECRUITING
city: Spilamberto
state: Modena
zip: 41057
country: Italy
contacts: [{name=Silvia Faccioli, MD PhD, role=CONTACT, phone=+39 0522 296208, email=silvia.faccioli@ausl.re.it}]
geoPoint: {lat=44.53273, lon=11.01697}

facility: IRCCS Fondazione Stella Maris
status: NOT_YET_RECRUITING
city: Pisa
zip: 56128
country: Italy
geoPoint: {lat=43.70853, lon=10.4036}

Conditions

Quadriplegia/Tetraplegia

TargetDisease

id: M5796
name: Cerebral Palsy
relevance: LOW

id: M13157
name: Paralysis
relevance: LOW

id: M14632
name: Quadriplegia
asFound: Quadriplegia
relevance: HIGH

id: M13066
name: Pain
relevance: LOW

id: M12404
name: Neurologic Manifestations
relevance: LOW

ProductName

IsActiveControl

IsControlDrug

IsPlacebo

ControlDrug

-

Intervention / Treatment

type: DIAGNOSTIC_TEST
name: Non-Ambulatory Hip Pain questionnaire
description: a new questionnaire for care givers to identify hip pain in pediatric patients with quadriplegia
armGroupLabels: [patients with quadriplegia]

Intervention

Study Type

INTERVENTIONAL

Phase

NA

Allocation

Interventional Model

SINGLE_GROUP

Subject Blind

Arm Label

* Participants are the caregivers that will fill out the questionnaire aimed at "diagnosing" their child's hip pain: they cannot be masked. * The physiatrist will verify the presence of hip pain while moving the hip during the visit, and assess it by means of the r-FLACC scale: he/she will be masked to the questionnaire. * The statistician will examine pooled data and compare the questionnaires with r-FLACC scale: he/she will be masked.

Arm Type

label: patients with quadriplegia
type: EXPERIMENTAL
description: Care givers of patients with quadriplegia will fill out a questionnaire aimed at identifying hip pain
interventionNames: [Diagnostic Test: Non-Ambulatory Hip Pain questionnaire]

NumberOfInterventionGroups

0

GroupEnrollment

Target Number of Participant

0

InstitutionLocation

InstitutionPhoneNumber

Study Site

Location Countries

Countries of recruitment

Study Start (Actual)

2024-07-17

Arm Description

The study includes the following steps: * development of the questionnaire to identify hip pain by means of a Delphi Method approach, involving a group of experts (clinicians and caregivers) * validation of the questionnaire by administering it to 100 caregivers of quadriplegic non-communicative patients * comparing results of the questionnaire with r-FLACC scale filled out by the physiatrist moving the hip during the visit

Inclusion and Exclusion Criteria

Inclusion Criteria: * GMFCS IV-V * CFCS III-V * subscription of consent Exclusion Criteria: * care givers not speaking Italian or English

minimum age

1 Year

maximum age

20 Years

Standard ages

CHILD

ADULT

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

NO

Enrollment (Actual)

100

Original Enrollment (Actual)

0

Final Enrollment Number

0

FinalSubjectSelectionDate

AnalysisTargetGroup

DemographicInformation

Primary Outcome Measures

measure: Content validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
description: 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.
timeFrame: 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.

measure: Internal reliability of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
description: 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.
timeFrame: 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

measure: Criterion validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)
description: 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.
timeFrame: 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.

PrimaryEndpointResult

Primary Completion Date (Actual)

2025-12

ClinicalTrialResultSummary

Telephone

Address

Name

Title

Telephone

name: Silvia Faccioli, MD PhD
role: CONTACT
phone: +39 0522 296208
email: silvia.faccioli@ausl.re.it

Affiliation