Postural Management for Hip Luxation in Quadriplegic Cerebral Palsy (CPluxprev2020)

May 4, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Azienda Unità Sanitaria Locale Reggio Emilia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Migration Percentage
Time Frame: Day 0, Month 12, Months 24
measure of hip luxation on pelvic radiography
Day 0, Month 12, Months 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, Month 12, Month 24
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.
Month 12, Month 24
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
Day 0, Month 6, Month 12, Month 18, Month 24
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
Day 0, Month 6, Month 12, Month 18, Month 24
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
Day 0, Month 6, Month 12, Month 18, Month 24
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
Day 0, Month 6, Month 12, Month 18, Month 24
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
Day 0, Month 6, Month 12, Month 18, Month 24
Type of CP (Dyskinetic or spastic)
Time Frame: Day 0
Type of CP will be recorded to evaluate any association with MP change
Day 0
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
Day 0
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
Day 0, Month 6, Month 12, Month 18, Month 24
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
Day 0
Age
Time Frame: Day 0
Age will be recorded to evaluate any association with MP change
Day 0
Sex
Time Frame: Day 0
Sex will be recorded to evaluate any association with MP change
Day 0
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
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Collaborators

Azienda Usl di Bologna
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IRCCS Eugenio Medea
Azienda Unita' Sanitaria Locale Di Modena
Azienda ULSS di Verona e Provincia
Ospedale IRCCS G. Gaslini di Genova
IRCCS Don Carlo Gnocchi di Firenze
Azienda Unità Sanitaria Locale della Romagna

Investigators

  • Study Chair: SILVIA FACCIOLI, Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2020

Primary Completion (Actual)

December 10, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 25, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 723/2020/SPER/AUSLRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are going to share results and data at the end of the study by publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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