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

Azienda USL Reggio Emilia - IRCCS

Status: Active, not recruiting

Conditions: Quadriplegic Cerebral Palsy

Treatments: Other: postural management

Study type: Interventional

Funder types: Other

Identifiers

NCT04603625

723/2020/SPER/AUSLRE

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

sitting position centering femoral heads

Experimental group

Description:

sitting position centering femoral heads according to Lespargot diagram

Treatment:

Other: postural management

Usual postural management

Active Comparator group

Description:

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

Treatment:

Other: postural management