NCT05657548

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress64%
Oct 2023Oct 2027

First Submitted

Initial submission to the registry

December 12, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

October 30, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

December 12, 2022

Last Update Submit

September 24, 2025

Conditions

Keywords

SpineChildAdolescentPelvisPostural BalancePostureRadiography

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)

Radiation: spine and pelvis radiography

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.

Child with Cerebral Palsy

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

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

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anissa MEGZARI

    Centre Hospitalier Universitaire de Nīmes

    STUDY DIRECTOR

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

Locations