Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
SPS-PC
2 other identifiers
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
September 29, 2025
September 1, 2025
3.9 years
December 12, 2022
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
Study Arms (1)
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)
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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 under court protection, guardianship or curatorship
- Pregnant, parturient or breastfeeding patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nîmes
Nîmes, 30029, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anissa MEGZARI
Centre Hospitalier Universitaire de Nīmes
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2022
First Posted
December 20, 2022
Study Start
October 30, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
September 29, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share