Clinical trial NCT05657548: Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Official title: Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy Infantile
Keywords: Spine
Child
Adolescent
Pelvis
Postural Balance
Posture
Radiography
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
measure: Evolution of the sagittal spinal statics in the sitting position
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: