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

Sponsor

Centre Hospitalier Universitaire de Nīmes (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05657548

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy Infantile	Radiation: spine and pelvis radiography

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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