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Recruiting NCT05657548

Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy

Observational Cerebral Palsy Infantile

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: spine and pelvis radiography.
Who it may be relevant to
Registry conditions: Cerebral Palsy Infantile. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Cerebral palsy is the leading cause of motor disability in children. Children with little or no walking (GMFCS III, IV and V) represent 43% of children with cerebral palsy, the majority of whom present pelvic and spinal deformities in the frontal and sagittal planes. However, sagittal pelvic spinal statics have been little studied, especially in the sitting position, which is the functional position of these children. Moreover, there are currently no recommendations on how to perform follow-up radiographs of the spine in children who do not walk much. A better understanding of pelvic and sagittal spinal statics would help prevent deformities and their complications. Standardizing the method of performing pelvic-spinal radiographs in the sitting position will make monitoring of spinal statics more reliable.

Interventions

  • Radiation spine and pelvis radiography
    X-ray of the spine and pelvis from the front and the side will be performed under the standardized conditions that we put in place: in a sitting position on a specific modular chair.

Primary outcome measures

  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]
  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]
  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]
  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]
  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]
  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]
  • Evolution of the sagittal spinal statics in the sitting position [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • Child or adolescent aged 4 to 17 years
  • Child or adolescent with cerebral palsy GMFCS III, IV or V
  • Child or adolescent whose parents, or the child if possible, have given free, informed and written consent
  • Child or adolescent affiliated or beneficiary of a health insurance plan

Exclusion criteria

  • Child or adolescent with history of spinal surgery
  • Child or adolescent with parents unable to give consent
  • Child or adolescent participating in a therapeutic research study (RIPH 1 or drug study)
  • Child or adolescent in an exclusion period determined by another study
  • Child or adolescent under court protection, guardianship or curatorship
  • Pregnant, parturient or breastfeeding patient

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de Nîmes — Nîmes

Identifiers

NCT: NCT05657548 · Local/2022/CL-01 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗