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Completed

NCT Number: NCT04603625

Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy

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.

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Key information

Conditions

Quadriplegic Cerebral Palsy

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

postural management

Other

postural management in sitting position

Primary outcomes

  1. Change in Migration Percentage

    Time frame: Day 0, Month 12, Months 24

    measure of hip luxation on pelvic radiography

Secondary outcomes

  1. Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD)

    Time frame: 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.

  2. Quebec User Evaluation of Satisfaction with Assistive Technology (IT-QUEST)

    Time frame: 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.

  3. Incidence of pain

    Time frame: 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

  4. Assistive devices costs

    Time frame: Day 0, Month 6, Month 12, Month 18, Month 24

    Costs paid by Health Institution for sitting systems used during the study

  5. Percentage of patients attending Botulinum Toxin-A injections

    Time frame: 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

  6. Percentage of patients attending direct physical treatment

    Time frame: Day 0, Month 6, Month 12, Month 18, Month 24

    Physiotherapy, other Neuromotor Therapy during the study

  7. Percentage of patients using standing devices in abduction

    Time frame: 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

  8. Type of CP (Dyskinetic or spastic)

    Time frame: Day 0

    Type of CP will be recorded to evaluate any association with MP change

  9. Percentage of patients having Intrathecal Baclofen (ITB)

    Time frame: Day 0

    It will be recorded if patients have ITB to evaluate any association with MP change

  10. Percentage of patients taking Baclofen per os

    Time frame: Day 0, Month 6, Month 12, Month 18, Month 24

    Baclofen oral medication during the study will be recorded

  11. Percentage of patients who underwent Selective Dorsal Rhizotomy (SDR)

    Time frame: Day 0

    It will be recorded if patients underwent SDR in the past to evaluate any association with MP change

  12. Age

    Time frame: Day 0

    Age will be recorded to evaluate any association with MP change

  13. Sex

    Time frame: Day 0

    Sex will be recorded to evaluate any association with MP change

  14. Type of lesion at MRI

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Collaborators

  • Azienda ULSS di Verona e Provincia
  • Azienda Unita' Sanitaria Locale Di Modena
  • Azienda Unità Sanitaria Locale della Romagna
  • 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

Registry information

Official study title

Postural Management to Prevent Hip Luxation in Quadriplegic Cerebral Palsy Children: Comparing Two Approaches in a Randomized Controlled Trial

Acronym: CPluxprev2020

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2020
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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