Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy

NCT04603625 | Completed DMC

• 1 other identifier: 723/2020/SPER/AUSLRE
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Quadriplegic Cerebral Palsy

Keywords

hip luxation

Outcome Measures

Primary Outcomes (1)

• Change in Migration Percentage

  measure of hip luxation on pelvic radiography

  Day 0, Month 12, Months 24

Secondary Outcomes (14)

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

  Day 0, Month 12, Month 24

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

  Month 12, Month 24

• Incidence of pain

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

• Assistive devices costs

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

• Percentage of patients attending Botulinum Toxin-A injections

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

Study Arms (2)

sitting position centering femoral heads

EXPERIMENTAL

sitting position centering femoral heads according to Lespargot diagram

Other: postural management

Usual postural management

ACTIVE COMPARATOR

sitting with the trunk aligned and hips abducted to facilitate activities of daily living

Other: postural management

Interventions

postural management OTHER

postural management in sitting position

Usual postural management; sitting position centering femoral heads

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• Ospedale IRCCS G. Gaslini di Genova: collaborator
• IRCCS Eugenio Medea: collaborator
• IRCCS Don Carlo Gnocchi di Firenze: collaborator
• Azienda Unita' Sanitaria Locale Di Modena: collaborator
• Azienda Usl di Bologna: collaborator
• Azienda Unità Sanitaria Locale della Romagna: collaborator
• Azienda ULSS di Verona e Provincia: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (1)

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, Italy

Location

Related Publications (17)

• 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.

  PMID: 24731007 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 30596451 BACKGROUND

• 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.

  PMID: 30326758 BACKGROUND

• 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.

  PMID: 17963501 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31169645 BACKGROUND

• 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.

  PMID: 21552077 BACKGROUND

• 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.

  PMID: 29578990 BACKGROUND

• 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.

  PMID: 28574172 BACKGROUND

• 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.

  PMID: 16978459 BACKGROUND

• 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.

  PMID: 27153480 BACKGROUND

• 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.

  PMID: 31256575 BACKGROUND

• 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.

  PMID: 22881288 BACKGROUND

• Wynter M, Gibson N, Willoughby KL, Love S, Kentish M, Thomason P, Graham HK; National Hip Surveillance Working Group. Australian hip surveillance guidelines for children with cerebral palsy: 5-year review. Dev Med Child Neurol. 2015 Sep;57(9):808-20. doi: 10.1111/dmcn.12754. Epub 2015 Apr 3.

  PMID: 25846730 BACKGROUND

• Faccioli S, Maggi I, Pagliano E, Migliorini C, Michelutti A, Guerra L, Ronchetti A, Cristella G, Battisti N, Mancini L, Picciolini O, Alboresi S, Trabacca A, Kaleci S. Sitting Postural Management to Prevent Migration Percentage Progression in Non-Ambulatory Children with Cerebral Palsy: Randomized Controlled Trial Preliminary Data. J Clin Med. 2024 May 27;13(11):3129. doi: 10.3390/jcm13113129.

  PMID: 38892841 DERIVED

Study Officials

• SILVIA FACCIOLI

  Azienda USL Reggio Emilia - IRCCS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physicians measuring Migration Percentage (Primary Outcome) will be blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 27, 2020
• Study Start: October 29, 2020
• Primary Completion: December 10, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)