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Recruiting Observational

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

NCT05657548 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-10-30
Last updated
2026-10-26

Condition(s) studied

Cerebral Palsy Infantile

Investigational drug(s) / intervention(s)

spine and pelvis radiography

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    measurement of pelvic incidence (normal values between 35 and 85 degrees)
  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees))
  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    pelvic version (angle between the vertical and the line joining the center of the femoral heads with the middle of the sacral plateau (in degrees))
  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    lordoses cervicales (in degrees)
  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    lumbar lordosis (in degrees)
  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    thoracic kyphosis (in degrees)
  • Evolution of the sagittal spinal statics in the sitting position — At baseline
    Cobb angle (if scoliosis) (curvature greater than 10 degrees : definition of scoliosis; between 10 and 15 degree: benign scoliosis; between 15 and 35 degrees: moderate scoliosis; curvature greater than 35 degrees: significant scoliosis.)

Trial sites (1)

FacilityCityRegionStatus
CHU de Nîmes Nîmes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05657548 on ClinicalTrials.gov ↗ ← All trials in France