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

Cerebral Palsy Infantile Clinical Trial

— SPS-PC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657548
• Other study ID #: Local/2022/CL-01
• Secondary ID: ANSM
• Status: Recruiting
• Start date: October 30, 2023
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Mélanie PORTE
• Phone: +33 4.66.68.34.59
• Email: melanie.porte[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Infantile

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the sagittal spinal statics in the sitting position	measurement of pelvic incidence (normal values between 35 and 85 degrees)	At baseline
Primary	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
Primary	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
Primary	Evolution of the sagittal spinal statics in the sitting position	lordoses cervicales (in degrees)	At baseline
Primary	Evolution of the sagittal spinal statics in the sitting position	lumbar lordosis (in degrees)	At baseline
Primary	Evolution of the sagittal spinal statics in the sitting position	thoracic kyphosis (in degrees)	At baseline
Primary	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