CPluxprev2020: Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sitting position centering femoral heads sitting position centering femoral heads according to Lespargot diagram |
Other: postural management
postural management in sitting position
|
| Active Comparator: Usual postural management sitting with the trunk aligned and hips abducted to facilitate activities of daily living |
Other: postural management
postural management in sitting position
|
Outcome Measures
Primary Outcome Measures
- Change in Migration Percentage [Day 0, Month 12, Months 24]
measure of hip luxation on pelvic radiography
Secondary Outcome Measures
- 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.
- 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.
- 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
- 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
- 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
- Type of CP (Dyskinetic or spastic) [Day 0]
Type of CP will be recorded to evaluate any association with MP change
- Percentage of patients having Intrathecal Baclofen (ITB) [Day 0]
It will be recorded if patients have ITB 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
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Unità Sanitaria Locale Reggio Emilia | Reggio Emilia | Italy |
Sponsors and Collaborators
- Azienda Unità Sanitaria Locale Reggio Emilia
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Ospedale IRCCS G. Gaslini di Genova
- IRCCS Eugenio Medea
- IRCCS Don Carlo Gnocchi di Firenze
- Azienda Unita' Sanitaria Locale Di Modena
- Azienda Usl di Bologna
- Azienda Unità Sanitaria Locale della Romagna
- Azienda ULSS di Verona e Provincia
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
- Study Chair: SILVIA FACCIOLI, Azienda Unità Sanitaria Locale Reggio Emilia
Study Documents (Full-Text)
None provided.More Information
Publications
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- 723/2020/SPER/AUSLRE