Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy

NCT ID: NCT04603625

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-29
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

sitting position centering femoral heads

sitting position centering femoral heads according to Lespargot diagram

Group Type: EXPERIMENTAL

postural management

Intervention Type: OTHER

postural management in sitting position

Usual postural management

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

Group Type: ACTIVE_COMPARATOR

postural management

Intervention Type: OTHER

postural management in sitting position

Interventions

postural management

postural management in sitting position

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Ospedale IRCCS G. Gaslini di Genova

UNKNOWN

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: collaborator

IRCCS Don Carlo Gnocchi di Firenze

UNKNOWN

Sponsor Role: collaborator

Azienda Unita' Sanitaria Locale Di Modena

OTHER

Sponsor Role: collaborator

Azienda Usl di Bologna

OTHER_GOV

Sponsor Role: collaborator

Azienda Unità Sanitaria Locale della Romagna

OTHER

Sponsor Role: collaborator

Azienda ULSS di Verona e Provincia

OTHER

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SILVIA FACCIOLI

Role: STUDY_CHAIR

Azienda USL Reggio Emilia - IRCCS

Locations

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, , Italy

Countries

Italy

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Other Identifiers

723/2020/SPER/AUSLRE

Identifier Type: -

Identifier Source: org_study_id