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Quadriplegic Cerebral PalsyCPluxprev2020NCT04603625

Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy

A study testing postural management in people with Quadriplegic Cerebral Palsy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cerebral palsy (CP) is the most common motor disability in childhood. Among these, hip luxation represents the most frequent and clinically relevant one, affecting 72% of non-ambulatory CP children. Read more about this study

Who is it for?
Ages 1 year to 6 years
Conditions the study is for
Quadriplegic Cerebral Palsy
What is being tested?
postural management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteItaly
Study dates
29 Oct 2020to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Cerebral palsy spastic or dyskinetic
  • GMFCS 4 or 5
  • MP<41%
  • Informed Consent acquired

Who cannot join

  • muscle contracture overcoming defined passive Range Of Motion (ROM)limits
  • anterior hip luxation
  • previous reconstructive hip surgery
  • preventive surgery in previous 12 months
  • lumbar scoliosis >20° Cobb

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Azienda Unità Sanitaria Locale Reggio Emilia

    Reggio Emilia

Other trials in Italy

About this study

Official title: Postural Management to Prevent Hip Luxation in Quadriplegic Cerebral Palsy Children: Comparing Two Approaches in a Randomized Controlled Trial

Cerebral palsy (CP) is the most common motor disability in childhood. Among these, hip luxation represents the most frequent and clinically relevant one, affecting 72% of non-ambulatory CP children. Reconstructive surgical treatment is debated in severe CP children, for whom it is crucial to identify an effective preventive approach. The aim of our study is to verify if keeping a sitting position centering femoral heads is more effective than usual postural management (sitting with the trunk aligned and hips abducted), in preventing hip luxation in quadriplegic CP children. It's a multicenter randomized controlled study (13 sites involved). A total of 102 quadriplegic CP children, aged 1-6 years-old, classified as Gross Motor Function Measure System 4 or 5, will be recruited and randomized to usual or experimental sitting, at least 5 hours a day, for 2 years. The primary outcome will be the degree of luxation, measured by means of the Migration Percentage (MP), on pelvic radiography, at 12 and 24 months. Secondary outcomes will include compliance and Health Related-Quality of Life, using validated tools, hip pain, device cost, MRI lesions, concurrent direct neuromotor treatment, use of standing devices and spasticity treatments (botulinum toxin, per os or intrathecal baclofen, selective dorsal rhizotomy). Experimental sitting is expected to reduce the MP change compared to usual care. It will be of interest to compare compliance, QoL and costs in either groups: aspects affecting the effectiveness. Furthermore to evaluate correlations between MP and spasticity treatments, MRI lesion type, and other clinical features.

Being tested
postural management
Keywords
hip luxation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • postural managementOther

    postural management in sitting position

Study groups in NCT04603625
Study groupRoleWhat they receive
sitting position centering femoral headsExperimentalsitting position centering femoral heads according to Lespargot diagram
Receives: Other: postural management
Usual postural managementActive comparatorsitting with the trunk aligned and hips abducted to facilitate activities of daily living
Receives: Other: postural management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Migration Percentage

    measure of hip luxation on pelvic radiography

    Measured: Day 0, Month 12, Months 24

Secondary outcomes (14)

  1. Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)

    Parents will fill in a questionnaire about Health Related Quality of Life referred to their child. Minimum value 0, maximum value 100, higher scores mean a better outcome.

    Measured: Day 0, Month 12, Month 24

  2. Quebec User Evaluation of Satisfaction with Assistive Technology (IT-QUEST)

    Parents will fill in a questionnaire measuring their satisfaction about the assistive device ensuring the desired sitting position of their child. Minimum value 1, maximum value 5,higher scores mean a better outcome.

    Measured: Month 12, Month 24

  3. Incidence of pain

    Care givers will be interviewed about presence or absence of hip pain in the previous months during personal care and activities of daily living

    Measured: Day 0, Month 6, Month 12, Month 18, Month 24

  4. Assistive devices costs

    Costs paid by Health Institution for sitting systems used during the study

    Measured: Day 0, Month 6, Month 12, Month 18, Month 24

  5. Percentage of patients attending Botulinum Toxin-A injections

    Botulinum Toxin-A injections in muscles around the hip during the study will be recorded

    Measured: Day 0, Month 6, Month 12, Month 18, Month 24

  6. Percentage of patients attending direct physical treatment

    Physiotherapy, other Neuromotor Therapy during the study

    Measured: Day 0, Month 6, Month 12, Month 18, Month 24

  7. Percentage of patients using standing devices in abduction

    It will be recorded if the patients will be using standing devices at least 5 hours/week, less than 5 h/week or never

    Measured: Day 0, Month 6, Month 12, Month 18, Month 24

  8. Type of CP (Dyskinetic or spastic)

    Type of CP will be recorded to evaluate any association with MP change

    Measured: Day 0

  9. Percentage of patients having Intrathecal Baclofen (ITB)

    It will be recorded if patients have ITB to evaluate any association with MP change

    Measured: Day 0

  10. Percentage of patients taking Baclofen per os

    Baclofen oral medication during the study will be recorded

    Measured: Day 0, Month 6, Month 12, Month 18, Month 24

  11. Percentage of patients who underwent Selective Dorsal Rhizotomy (SDR)

    It will be recorded if patients underwent SDR in the past to evaluate any association with MP change

    Measured: Day 0

  12. Age

    Age will be recorded to evaluate any association with MP change

    Measured: Day 0

  13. Sex

    Sex will be recorded to evaluate any association with MP change

    Measured: Day 0

  14. Type of lesion at MRI

    Type of lesion at MRI, according to Neonatal Neuroimaging Classification System (maldevelopments | predominant white matter injury | predominant grey matter injury | miscellaneous | Normal). Data will be registered based on previously acquired MRI, considering that the exam is mandatory for the diagnosis of cerebral palsy. It will be recorded to evaluate any association with MP change

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2020
  2. Study start29 Oct 2020
  3. Primary completion10 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04603625
Sponsor's protocol ID
723/2020/SPER/AUSLRE
Acronym
CPluxprev2020
Status last verified
May 2026
First submitted
1 Oct 2020
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We are going to share results and data at the end of the study by publication

Publications

  • Bouwhuis CB, van der Heijden-Maessen HC, Boldingh EJ, Bos CF, Lankhorst GJ. Effectiveness of preventive and corrective surgical intervention on hip disorders in severe cerebral palsy: a systematic review. Disabil Rehabil. 2015;37(2):97-105. doi: 10.3109/09638288.2014.908961. Epub 2014 Apr 14.

    PubMed 24731007

  • Dalen Y, Saaf M, Ringertz H, Klefbeck B, Mattsson E, Haglund-Akerlind Y. Effects of standing on bone density and hip dislocation in children with severe cerebral palsy. Adv Physiother,2010;12:187-93.

  • Diab M, Staheli LT. Ortopedia Pediatrica, 3° ed., Verduci ed., p.65

  • Galeoto G, Colucci M, Guarino D, Esposito G, Cosma E, De Santis R, Grifoni G, Valente D, Tofani M. Exploring Validity, Reliability, and Factor Analysis of the Quebec User Evaluation of Satisfaction with Assistive Technology in an Italian Population: A Cross-Sectional Study. Occup Ther Health Care. 2018 Oct;32(4):380-392. doi: 10.1080/07380577.2018.1522682. Epub 2018 Dec 31.

    PubMed 30596451

  • Hagglund G, Goldring M, Hermanson M, Rodby-Bousquet E. Pelvic obliquity and measurement of hip displacement in children with cerebral palsy. Acta Orthop. 2018 Dec;89(6):652-655. doi: 10.1080/17453674.2018.1519104. Epub 2018 Oct 17.

    PubMed 30326758

  • Hagglund G, Lauge-Pedersen H, Wagner P. Characteristics of children with hip displacement in cerebral palsy. BMC Musculoskelet Disord. 2007 Oct 26;8:101. doi: 10.1186/1471-2474-8-101.

    PubMed 17963501

  • • Lespargot A. La luxation postéro-externe de la hanche chez l'enfant IMC ou polyhandicapé. Motricité cérébrale,1991;12:37-61

  • Lins LAB, Watkins CJ, Shore BJ. Natural History of Spastic Hip Disease. J Pediatr Orthop. 2019 Jul;39(Issue 6, Supplement 1 Suppl 1):S33-S37. doi: 10.1097/BPO.0000000000001347.

    PubMed 31169645

  • Martinsson C, Himmelmann K. Effect of weight-bearing in abduction and extension on hip stability in children with cerebral palsy. Pediatr Phys Ther. 2011 Summer;23(2):150-7. doi: 10.1097/PEP.0b013e318218efc3.

    PubMed 21552077

  • Gmelig Meyling C, Ketelaar M, Kuijper MA, Voorman J, Buizer AI. Effects of Postural Management on Hip Migration in Children With Cerebral Palsy: A Systematic Review. Pediatr Phys Ther. 2018 Apr;30(2):82-91. doi: 10.1097/PEP.0000000000000488.

    PubMed 29578990

  • Miller SD, Juricic M, Hesketh K, Mclean L, Magnuson S, Gasior S, Schaeffer E, O'donnell M, Mulpuri K. Prevention of hip displacement in children with cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Nov;59(11):1130-1138. doi: 10.1111/dmcn.13480. Epub 2017 Jun 2.

    PubMed 28574172

  • Narayanan UG, Fehlings D, Weir S, Knights S, Kiran S, Campbell K. Initial development and validation of the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD). Dev Med Child Neurol. 2006 Oct;48(10):804-12. doi: 10.1017/S0012162206001745.

    PubMed 16978459

  • Picciolini O, LE Metayer M, Consonni D, Cozzaglio M, Porro M, Gasparroni V, Panou A, Mosca F, Portinaro NM. Can we prevent hip dislocation in children with cerebral palsy? Effects of postural management. Eur J Phys Rehabil Med. 2016 Oct;52(5):682-690. Epub 2016 May 6.

    PubMed 27153480

  • Sproccati N, Bertana S, Battisti N, Feliciangeli A, Baroncini C, Zenesini C, Cersosimo A. Italian translation and cross-cultural adaptation of the questionnaire for the assessment of quality of life in children with cerebral palsy: Caregiver priorities and Child Health Index of Life with disabilities. Minerva Med. 2021 Oct;112(5):651-653. doi: 10.23736/S0026-4806.19.06072-5. Epub 2019 Jun 25. No abstract available.

    PubMed 31256575

  • Terjesen T. The natural history of hip development in cerebral palsy. Dev Med Child Neurol. 2012 Oct;54(10):951-7. doi: 10.1111/j.1469-8749.2012.04385.x. Epub 2012 Aug 13.

    PubMed 22881288

Questions about this trial

What is this clinical trial studying?

A study testing postural management in people with Quadriplegic Cerebral Palsy, run by Azienda USL Reggio Emilia - IRCCS at 1 site 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 4 inclusion and 5 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: finished, 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 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Migration Percentage (time frame: Day 0, Month 12, Months 24). 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 NCT04603625, which also lists 17 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.

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