Clinical trial NCT04603625: Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy
Official title: Postural Management to Prevent Hip Luxation in Quadriplegic Cerebral Palsy Children: Comparing Two Approaches in a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Quadriplegic Cerebral Palsy
Keywords: hip luxation
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: Ospedale IRCCS G. Gaslini di Genova
name: IRCCS Eugenio Medea
name: IRCCS Don Carlo Gnocchi di Firenze
name: Azienda Unita' Sanitaria Locale Di Modena
name: Azienda Usl di Bologna
name: Azienda Unità Sanitaria Locale della Romagna
name: Azienda ULSS di Verona e Provincia
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
First posted: 2020-10-27
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Migration Percentage
timeFrame: Day 0, Month 12, Months 24
Secondary outcomes:
measure: Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
timeFrame: Day 0, Month 12, Month 24
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (IT-QUEST)
timeFrame: Month 12, Month 24
measure: Incidence of pain
timeFrame: Day 0, Month 6, Month 12, Month 18, Month 24
measure: Assistive devices costs
timeFrame: Day 0, Month 6, Month 12, Month 18, Month 24
measure: Percentage of patients attending Botulinum Toxin-A injections
timeFrame: Day 0, Month 6, Month 12, Month 18, Month 24
measure: Percentage of patients attending direct physical treatment
timeFrame: Day 0, Month 6, Month 12, Month 18, Month 24
measure: Percentage of patients using standing devices in abduction
timeFrame: Day 0, Month 6, Month 12, Month 18, Month 24
measure: Type of CP (Dyskinetic or spastic)
timeFrame: Day 0
measure: Percentage of patients having Intrathecal Baclofen (ITB)
timeFrame: Day 0
measure: Percentage of patients taking Baclofen per os
timeFrame: Day 0, Month 6, Month 12, Month 18, Month 24
measure: Percentage of patients who underwent Selective Dorsal Rhizotomy (SDR)
timeFrame: Day 0
measure: Age
timeFrame: Day 0
measure: Sex
timeFrame: Day 0
measure: Type of lesion at MRI
timeFrame: Day 0
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale Reggio Emilia
Study officials:
affiliation: Azienda USL Reggio Emilia - IRCCS
name: SILVIA FACCIOLI
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Diab M, Staheli LT. Ortopedia Pediatrica, 3° ed., Verduci ed., p.65
citation: 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.
citation: 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.
citation: 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.
citation: • Lespargot A. La luxation postéro-externe de la hanche chez l'enfant IMC ou polyhandicapé. Motricité cérébrale,1991;12:37-61
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.