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

NCT06798233 | Recruiting

• 1 other identifier: 254/2024/SPER/AUSLRE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is twofold:

1. 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. 2.to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia
3. 3.involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire
4. 4.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
5. 5.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
6. 6.as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit

Conditions

Quadriplegia/Tetraplegia

Keywords

hip pain; pain measurements; children; adolescents; cerebral palsy

Outcome Measures

Primary Outcomes (2)

• Content validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)

  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)

  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 Outcomes (1)

• Criterion validity of the Non-Ambulatory Hip Pain questionnaire (NAHPq)

  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.

Study Arms (1)

patients with quadriplegia

EXPERIMENTAL

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

Diagnostic Test: Non-Ambulatory Hip Pain questionnaire

Interventions

Non-Ambulatory Hip Pain questionnaire DIAGNOSTIC_TEST

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

patients with quadriplegia

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• care givers not speaking Italian or English

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• IRCCS Fondazione Stella Maris: collaborator

Study Sites (2)

IRCCS Fondazione Stella Maris

Pisa, Italy, 56128, Italy

NOT YET RECRUITING

AziendaUSL IRCCS Reggio Emilia

Spilamberto, Modena, 41057, Italy

RECRUITING

Related Publications (11)

• Hidecker MJ, Paneth N, Rosenbaum PL, Kent RD, Lillie J, Eulenberg JB, Chester K Jr, Johnson B, Michalsen L, Evatt M, Taylor K. Developing and validating the Communication Function Classification System for individuals with cerebral palsy. Dev Med Child Neurol. 2011 Aug;53(8):704-10. doi: 10.1111/j.1469-8749.2011.03996.x. Epub 2011 Jun 27.

  PMID: 21707596 BACKGROUND

• Fox MA, Ayyangar R, Parten R, Haapala HJ, Schilling SG, Kalpakjian CZ. Self-report of pain in young people and adults with spastic cerebral palsy: interrater reliability of the revised Face, Legs, Activity, Cry, and Consolability (r-FLACC) scale ratings. Dev Med Child Neurol. 2019 Jan;61(1):69-74. doi: 10.1111/dmcn.13980. Epub 2018 Jul 27.

  PMID: 30051908 BACKGROUND

• Caravau H, Rosa AF, Rocha NP, Silva AG. Pain assessment in cerebral palsy: a systematic review of measurement properties and evaluation using the COSMIN checklist. Disabil Rehabil. 2022 Mar;44(6):910-920. doi: 10.1080/09638288.2020.1783000. Epub 2020 Jul 3.

  PMID: 32619368 BACKGROUND

• Boldingh EJ, Jacobs-van der Bruggen MA, Lankhorst GJ, Bouter LM. Assessing pain in patients with severe cerebral palsy: development, reliability, and validity of a pain assessment instrument for cerebral palsy. Arch Phys Med Rehabil. 2004 May;85(5):758-66. doi: 10.1016/j.apmr.2003.06.029.

  PMID: 15129400 BACKGROUND

• Letzkus L, Fehlings D, Ayala L, Byrne R, Gehred A, Maitre NL, Noritz G, Rosenberg NS, Tanner K, Vargus-Adams J, Winter S, Lewandowski DJ, Novak I. A Systematic Review of Assessments and Interventions for Chronic Pain in Young Children With or at High Risk for Cerebral Palsy. J Child Neurol. 2021 Aug;36(9):697-710. doi: 10.1177/0883073821996916. Epub 2021 Mar 9.

  PMID: 33719661 BACKGROUND

• Jozwiak M, Harasymczuk P, Koch A, Kotwicki T. Incidence and risk factors of hip joint pain in children with severe cerebral palsy. Disabil Rehabil. 2011;33(15-16):1367-72. doi: 10.3109/09638288.2010.532281. Epub 2010 Nov 20.

  PMID: 21091045 BACKGROUND

• Faccioli S, Sassi S, Ferrari A, Corradini E, Toni F, Kaleci S, Lombardi F, Picelli A, Benedetti MG. Prevalence and determinants of hip pain in non-ambulatory cerebral palsy children: a retrospective cohort study. Eur J Phys Rehabil Med. 2023 Feb;59(1):32-41. doi: 10.23736/S1973-9087.22.07725-5. Epub 2022 Dec 12.

  PMID: 36507793 BACKGROUND

• Jayanath S, Ong LC, Marret MJ, Fauzi AA. Parent-reported pain in non-verbal children and adolescents with cerebral palsy. Dev Med Child Neurol. 2016 Apr;58(4):395-401. doi: 10.1111/dmcn.12943. Epub 2015 Oct 28.

  PMID: 26510627 BACKGROUND

• Kingsnorth S, Orava T, Provvidenza C, Adler E, Ami N, Gresley-Jones T, Mankad D, Slonim N, Fay L, Joachimides N, Hoffman A, Hung R, Fehlings D. Chronic Pain Assessment Tools for Cerebral Palsy: A Systematic Review. Pediatrics. 2015 Oct;136(4):e947-60. doi: 10.1542/peds.2015-0273.

  PMID: 26416940 BACKGROUND

• Penner M, Xie WY, Binepal N, Switzer L, Fehlings D. Characteristics of pain in children and youth with cerebral palsy. Pediatrics. 2013 Aug;132(2):e407-13. doi: 10.1542/peds.2013-0224. Epub 2013 Jul 15.

  PMID: 23858420 BACKGROUND

• Ostojic K, Paget S, Kyriagis M, Morrow A. Acute and Chronic Pain in Children and Adolescents With Cerebral Palsy: Prevalence, Interference, and Management. Arch Phys Med Rehabil. 2020 Feb;101(2):213-219. doi: 10.1016/j.apmr.2019.08.475. Epub 2019 Sep 12.

  PMID: 31521713 BACKGROUND

MeSH Terms

Conditions

Quadriplegia; Cerebral Palsy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Silvia Faccioli, MD PhD

CONTACT

+39 0522 296208; silvia.faccioli@ausl.re.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: * 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 29, 2025
• Study Start: July 17, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)