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NCT Number: NCT05657548

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

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.

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Key information

Conditions

Cerebral Palsy Infantile Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spine and pelvis radiography

Radiation

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.

Primary outcomes

  1. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    measurement of pelvic incidence (normal values between 35 and 85 degrees)

  2. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    sacral slope (angle of inclination of the sacral plateau in profile to the horizontal (degrees))

  3. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    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))

  4. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    lordoses cervicales (in degrees)

  5. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    lumbar lordosis (in degrees)

  6. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    thoracic kyphosis (in degrees)

  7. Evolution of the sagittal spinal statics in the sitting position

    Time frame: At baseline

    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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Cloé LAFFARGUE

CONTACT

[email protected]

+33 4.66.68.34.59

Mélanie PORTE

CONTACT

[email protected]

+33 4.66.68.34.59

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: SPS-PC

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 20, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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