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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
72
postural management in sitting position
Azienda Unità Sanitaria Locale Reggio Emilia
Reggio Emilia, Italy
Change in Migration Percentage
measure of hip luxation on pelvic radiography
Time frame: Day 0, Month 12, Months 24
Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)
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.
Time frame: Day 0, Month 12, Month 24
Quebec User Evaluation of Satisfaction with Assistive Technology (IT-QUEST)
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.
Time frame: Month 12, Month 24
Incidence of pain
Care givers will be interviewed about presence or absence of hip pain in the previous months during personal care and activities of daily living
Time frame: Day 0, Month 6, Month 12, Month 18, Month 24
Assistive devices costs
Costs paid by Health Institution for sitting systems used during the study
Time frame: Day 0, Month 6, Month 12, Month 18, Month 24
Percentage of patients attending Botulinum Toxin-A injections
Botulinum Toxin-A injections in muscles around the hip during the study will be recorded
Time frame: Day 0, Month 6, Month 12, Month 18, Month 24
Percentage of patients attending direct physical treatment
Physiotherapy, other Neuromotor Therapy during the study
Time frame: Day 0, Month 6, Month 12, Month 18, Month 24
Percentage of patients using standing devices in abduction
It will be recorded if the patients will be using standing devices at least 5 hours/week, less than 5 h/week or never
Time frame: Day 0, Month 6, Month 12, Month 18, Month 24
Type of CP (Dyskinetic or spastic)
Type of CP will be recorded to evaluate any association with MP change
Time frame: Day 0
Percentage of patients having Intrathecal Baclofen (ITB)
It will be recorded if patients have ITB to evaluate any association with MP change
Time frame: Day 0
Percentage of patients taking Baclofen per os
Baclofen oral medication during the study will be recorded
Time frame: Day 0, Month 6, Month 12, Month 18, Month 24
Percentage of patients who underwent Selective Dorsal Rhizotomy (SDR)
It will be recorded if patients underwent SDR in the past to evaluate any association with MP change
Time frame: Day 0
Age
Age will be recorded to evaluate any association with MP change
Time frame: Day 0
Sex
Sex will be recorded to evaluate any association with MP change
Time frame: Day 0
Type of lesion at MRI
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
Time frame: Day 0
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