Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy (CPluxprev2020)

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

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

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.

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.

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.

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

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

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

Inclusion Criteria: Cerebral palsy spastic or dyskinetic GMFCS 4 or 5 MP<41% Informed Consent acquired Exclusion Criteria: 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

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.

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.

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.

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.

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.

• 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.

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.

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.

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.

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.

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.

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.

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.

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.