연구제목

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

연구요약

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

연구의뢰자

Azienda USL Reggio Emilia - IRCCS

연구모집현황

RECRUITING

임상시험의 목적

DIAGNOSTIC

ClinicalTrials.gov 등록번호

NCT06798233

추가 연구 번호

최신갱신일

2025-06-11

연구종료일

2026-12

연구 버전 기록

실시기관명

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}

연구대상 상태/질환

Quadriplegia/Tetraplegia

대상질환

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

제품명(코드명)

활성대조약 여부

대조약 여부

위약 여부

대조약

-

중재/치료

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]

중재 방법

연구종류

INTERVENTIONAL

임상시험단계

NA

배정

중재모형

SINGLE_GROUP

눈가림대상자

중재군명

* 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.

중재군 유형

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]

중재군 수

0

중재군 별 설명 및 등록 환자수

중재군 목표대상자 수

0

기관소재지

실시기관 전화번호

연구참여기관

국가

환자모집국가

최초 연구대상자 등록일

2024-07-17

상세내용

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

대상자 선정 및 제외기준

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

참여 가능한 연령 하한

1 Year

참여 가능한 연령 상한

20 Years

참여 가능한 표준 연령

CHILD

ADULT

대상자 포함기준 성별

ALL

건강인 참여 여부

NO

실제 대상자수

100

기존 목표대상자 수(실제)

0

최종 연구대상자 수

0

최종 시험대상자 선정일

시험대상자 > 분석대상군

시험대상자 > 인구학적 정보

주요결과변수

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.

보조결과변수

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.

주요 평가 > 1차 평가변수 결과

최종 주평가변수 수집 완료일

2025-12

임상시험결과요약

연구책임자 전화번호

연구책임자 주소

연구실무담당자 성명

연구실무담당자 직위

연구실무담당자 전화번호

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

연구실무담당자 기관명