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

Recruiting

• Conditions: Cerebral Palsy Infantile
• Interventions: Radiation: spine and pelvis radiography

• Registration Number: NCT05657548
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-20
• Study Start: 2023-10-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Child with Cerebral Palsy	spine and pelvis radiography	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)

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

CHU de Nîmes; 🇫🇷 Nîmes, France