Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy

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

Interventions

OTHER

postural management

postural management in sitting position

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

  collaborator OTHER

• Ospedale IRCCS G. Gaslini di Genova

  collaborator UNKNOWN

• IRCCS Eugenio Medea

  collaborator OTHER

• IRCCS Don Carlo Gnocchi di Firenze

  collaborator UNKNOWN

• Azienda Unita' Sanitaria Locale Di Modena

  collaborator OTHER

• Azienda Usl di Bologna

  collaborator OTHER_GOV

• Azienda Unità Sanitaria Locale della Romagna

  collaborator OTHER

• Azienda ULSS di Verona e Provincia

  collaborator OTHER

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  lead OTHER_GOV

Principal Investigators

• SILVIA FACCIOLI · Azienda USL Reggio Emilia - IRCCS

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

6 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-29

Primary Completion

2025-12-10

Completion

2025-12-31

Countries

• Italy

Study Locations