Quadriplegic Cerebral Palsy Clinical Trial
— CPluxprev2020Official title:
Postural Management to Prevent Hip Luxation in Quadriplegic Cerebral Palsy Children: Comparing Two Approaches in a Randomized Controlled Trial
| Verified date | February 2024 |
| Source | Azienda Unità Sanitaria Locale Reggio Emilia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 72 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 6 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Azienda Unità Sanitaria Locale Reggio Emilia | Reggio Emilia |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Unità Sanitaria Locale Reggio Emilia | Azienda ULSS di Verona e Provincia, Azienda Unità Sanitaria Locale della Romagna, Azienda Unita' Sanitaria Locale Di Modena, Azienda Usl di Bologna, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, IRCCS Don Carlo Gnocchi di Firenze, IRCCS Eugenio Medea, Ospedale IRCCS G. Gaslini di Genova |
Italy,
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* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Migration Percentage | measure of hip luxation on pelvic radiography | Day 0, Month 12, Months 24 | |
| Secondary | 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. | Day 0, Month 12, Month 24 | |
| Secondary | 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. | Month 12, Month 24 | |
| Secondary | 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 | Day 0, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | Assistive devices costs | Costs paid by Health Institution for sitting systems used during the study | Day 0, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | Percentage of patients attending Botulinum Toxin-A injections | Botulinum Toxin-A injections in muscles around the hip during the study will be recorded | Day 0, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | Percentage of patients attending direct physical treatment | Physiotherapy, other Neuromotor Therapy during the study | Day 0, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | 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 | Day 0, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | Type of CP (Dyskinetic or spastic) | Type of CP will be recorded to evaluate any association with MP change | Day 0 | |
| Secondary | Percentage of patients having Intrathecal Baclofen (ITB) | It will be recorded if patients have ITB to evaluate any association with MP change | Day 0 | |
| Secondary | Percentage of patients taking Baclofen per os | Baclofen oral medication during the study will be recorded | Day 0, Month 6, Month 12, Month 18, Month 24 | |
| Secondary | 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 | Day 0 | |
| Secondary | Age | Age will be recorded to evaluate any association with MP change | Day 0 | |
| Secondary | Sex | Sex will be recorded to evaluate any association with MP change | Day 0 | |
| Secondary | 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 | Day 0 |