Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy (NCT05657548) | Clinical Trial Compass
RecruitingNot Applicable
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
France100 participantsStarted 2023-10-30
Plain-language 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.
Who can participate
Age range
4 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evolution of the sagittal spinal statics in the sitting position
Timeframe: At baseline
2
Evolution of the sagittal spinal statics in the sitting position
Timeframe: At baseline
3
Evolution of the sagittal spinal statics in the sitting position
Timeframe: At baseline
4
Evolution of the sagittal spinal statics in the sitting position
Timeframe: At baseline
5
Evolution of the sagittal spinal statics in the sitting position
Timeframe: At baseline
6
Evolution of the sagittal spinal statics in the sitting position
Timeframe: At baseline
7
Evolution of the sagittal spinal statics in the sitting position