Quadriplegia/TetraplegiaNAHPqNCT06798233
Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
A study testing Non-Ambulatory Hip Pain questionnaire in people with Quadriplegia/Tetraplegia, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- Quadriplegia/Tetraplegia
- What is being tested?
- Non-Ambulatory Hip Pain questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 17 Jul 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- GMFCS IV-V
- CFCS III-V
- subscription of consent
Who cannot join
- care givers not speaking Italian or English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS Fondazione Stella Maris
Pisa, Italy, 56128
- Recruiting
AziendaUSL IRCCS Reggio Emilia
Spilamberto, Modena, 41057
Silvia Faccioli, MD PhD, +39 0522 296208, silvia.faccioli@ausl.re.it
About this study
The goal of this clinical trial is twofold:
- to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently
- to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia
Read more
Researchers will :
- involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire
- 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:
- 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
- as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit
Read the 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.
- Conditions
- Quadriplegia/Tetraplegia
- Being tested
- Non-Ambulatory Hip Pain questionnaire
- Keywords
- hip pain, pain measurements, children, adolescents, cerebral palsy
- Medical subject headings
- Quadriplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Ambulatory Hip Pain questionnaireDiagnostic test
a new questionnaire for care givers to identify hip pain in pediatric patients with quadriplegia
| Study group | Role | What they receive |
|---|---|---|
| patients with quadriplegia | Experimental | Care givers of patients with quadriplegia will fill out a questionnaire aimed at identifying hip pain Receives: Diagnostic Test: Non-Ambulatory Hip Pain questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start17 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Quadriplegia/TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- IRCCS Fondazione Stella Maris
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798233
- Sponsor's protocol ID
- 254/2024/SPER/AUSLRE
- Acronym
- NAHPq
- Status last verified
- May 2026
- First submitted
- 3 Jan 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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)
Publications
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.
PubMed 21707596Fox 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.
PubMed 30051908Caravau 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.
PubMed 32619368Boldingh 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.
PubMed 15129400Letzkus 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.
PubMed 33719661Jozwiak 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.
PubMed 21091045Faccioli 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.
PubMed 36507793Jayanath 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.
PubMed 26510627Kingsnorth 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.
PubMed 26416940Penner 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.
PubMed 23858420Ostojic 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.
PubMed 31521713
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a New Questionnaire for Caregivers to Assess Hip Pain in Quadriplegic Pediatric Patients: Non-Ambulatory Hip Pain Questionnaire
- ClinicalTrials.gov ID
- NCT06798233
- Acronym / sponsor ID
- NAHPq / 254/2024/SPER/AUSLRE
- Conditions
- Quadriplegia/Tetraplegia
- Keywords
- hip pain, pain measurements, children, adolescents, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- IRCCS Fondazione Stella Maris
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is twofold:
- to develop a questionnaire for care givers to assess hip pain in quadriplegic pediatric patients who are not able to communicate it independently
- to validate this questionnaire in a cohort of 100 pediatric patients with quadriplegia
Researchers will :
- involve 10 experts (8 multiprofessional clinicians and 2 parents) in a Delphi approach to develop the questionnaire
- 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:
- 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
- as caregivers of pediatric patients with quadriplegia, fill out the questionnaire within 2 weeks after the visit
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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
| Arm | Type | Receives |
|---|---|---|
| patients with quadriplegia | Experimental | Diagnostic Test: Non-Ambulatory Hip Pain questionnaireCare givers of patients with quadriplegia will fill out a questionnaire aimed at identifying hip pain |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- GMFCS IV-V
- CFCS III-V
- subscription of consent
Key exclusion criteria (1 listed)
- care givers not speaking Italian or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Ambulatory Hip Pain questionnairea new questionnaire for care givers to identify hip pain in pediatric patients with quadriplegia | Diagnostic test | patients with quadriplegia |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 21707596Hidecker 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.
- Background: PubMed 30051908Fox 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.
- Background: PubMed 32619368Caravau 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.
- Background: PubMed 15129400Boldingh 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.
- Background: PubMed 33719661Letzkus 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.
- Background: PubMed 21091045Jozwiak 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.
- Background: PubMed 36507793Faccioli 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.
- Background: PubMed 26510627Jayanath 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.
- Background: PubMed 26416940Kingsnorth 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.
- Background: PubMed 23858420Penner 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.
- Background: PubMed 31521713Ostojic 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.
- Individual participant dataSharing planned: No. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Ambulatory Hip Pain questionnaire in people with Quadriplegia/Tetraplegia, run by Azienda USL Reggio Emilia - IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Faccioli, MD PhD (+39 0522 296208, silvia.faccioli@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798233, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.