Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy
- Conditions
- Quadriplegic Cerebral Palsy
- Interventions
- Other: postural management
- Registration Number
- NCT04603625
- Lead Sponsor
- Azienda Unità Sanitaria Locale Reggio Emilia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- Cerebral palsy spastic or dyskinetic
- GMFCS 4 or 5
- MP<41%
- Informed Consent acquired
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual postural management postural management sitting with the trunk aligned and hips abducted to facilitate activities of daily living sitting position centering femoral heads postural management sitting position centering femoral heads according to Lespargot diagram
- Primary Outcome Measures
Name Time Method Change in Migration Percentage Day 0, Month 12, Months 24 measure of hip luxation on pelvic radiography
- Secondary Outcome Measures
Name Time Method Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Day 0, Month 12, Month 24 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.
Assistive devices costs Day 0, Month 6, Month 12, Month 18, Month 24 Costs paid by Health Institution for sitting systems used during the study
Percentage of patients attending Botulinum Toxin-A injections Day 0, Month 6, Month 12, Month 18, Month 24 Botulinum Toxin-A injections in muscles around the hip during the study will be recorded
Age Day 0 Age will be recorded to evaluate any association with MP change
Sex Day 0 Sex will be recorded to evaluate any association with MP change
Incidence of pain Day 0, Month 6, Month 12, Month 18, Month 24 Care givers will be interviewed about presence or absence of hip pain in the previous months during personal care and activities of daily living
Type of CP (Dyskinetic or spastic) Day 0 Type of CP will be recorded to evaluate any association with MP change
Percentage of patients taking Baclofen per os Day 0, Month 6, Month 12, Month 18, Month 24 Baclofen oral medication during the study will be recorded
Percentage of patients who underwent Selective Dorsal Rhizotomy (SDR) Day 0 It will be recorded if patients underwent SDR in the past to evaluate any association with MP change
Quebec User Evaluation of Satisfaction with Assistive Technology (IT-QUEST) Month 12, Month 24 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.
Percentage of patients attending direct physical treatment Day 0, Month 6, Month 12, Month 18, Month 24 Physiotherapy, other Neuromotor Therapy during the study
Percentage of patients using standing devices in abduction Day 0, Month 6, Month 12, Month 18, Month 24 It will be recorded if the patients will be using standing devices at least 5 hours/week, less than 5 h/week or never
Percentage of patients having Intrathecal Baclofen (ITB) Day 0 It will be recorded if patients have ITB to evaluate any association with MP change
Type of lesion at MRI Day 0 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
Trial Locations
- Locations (1)
Azienda Unità Sanitaria Locale Reggio Emilia
🇮🇹Reggio Emilia, Italy