Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy (SPS-PC)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy Infantile
• Intervention / Treatment: Radiation: spine and pelvis radiography

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mélanie PORTE; Phone Number: +33 4.66.68.34.59; Email: melanie.porte@chu-nimes.fr
• Study Contact Backup: Name: Cloé LAFFARGUE; Phone Number: +33 4.66.68.34.59; Email: cloe.laffargue@gmail.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Contact: Mélanie PORTE; Phone Number: +33466683459; Email: melanie.porte@chu-nimes.fr
    • Contact: Cloé LAFFARGUE; Phone Number: +33466683459; Email: cloe.laffargue@gmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children Rehabilitation Unit of the CHU of Nîmes

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Child with Cerebral Palsy; Children and adolescents from 4 to 17 years old with cerebral palsy GMFCS III, IV or V followed in the Physical Medicine and Rehabilitation Department, Children's Rehabilitation Unit of the University Hospital of Nîmes (Carémeau Hospital)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the sagittal spinal statics in the sitting position	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))	At baseline
Evolution of the sagittal spinal statics in the sitting position	lordoses cervicales (in degrees)	At baseline
Evolution of the sagittal spinal statics in the sitting position	lumbar lordosis (in degrees)	At baseline
Evolution of the sagittal spinal statics in the sitting position	thoracic kyphosis (in degrees)	At baseline
Evolution of the sagittal spinal statics in the sitting position	measurement of pelvic incidence (normal values between 35 and 85 degrees)	At baseline
Evolution of the sagittal spinal statics in the sitting position	sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees))	At baseline
Evolution of the sagittal spinal statics in the sitting position	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.)	At baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Anissa MEGZARI, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Adolescent; Child; Posture; Postural Balance; Spine; Pelvis; Radiography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Local/2022/CL-01; ANSM (Other Identifier: 2025-A01697-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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