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NCT Number: NCT06320288

Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL)

During the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. Indeed, its development is strongly linked to the overall motor function of children. In cerebral palsy (CP), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. These deficits are strongly correlated with the functional deficits observed in this population. In particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. While recent literature increasingly questions the impact of trunk control deficit on the walking of children with CP, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with CP. In particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with CP. Therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with CP.

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Key information

Age range

18 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

Location status: Recruiting

Location contact

Jonathan Pierret, PhD

CONTACT

[email protected]

+33 3 82 52 6761

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children (< 18 years) with cerebral palsy
  • GMFCS I to III
  • Independent walking with or without technical walking aids (walker, crutches, etc.)
  • Able to understand the instructions of various clinical assessments and functional explorations
  • Affiliated with a social security scheme

Exclusion criteria

Children with cerebral palsy

  • Neuro-orthopaedic surgery of the lower limbs or trunk within the last 12 months
  • Botulinum toxin A injections within the last 6 months
  • Therapeutic intervention targeting trunk control last 6 months

Typically developing children

  • Surgery on lower limbs or trunk last 12 months
  • Neurological and/or orthopedic pathology that may influence gait

Treatment and study plan

Primary outcomes

  1. Trunk and center-of-mass accelerations and acceleration variability

    Time frame: At the end of the one-day experimental

    In addition to the zeno walking track, inertial computers will be used to record accelerations of the patient's trunk and center of mass as they walk. One will be attached to the sternum, the other to the lumbosacral hinge, using hypoallergenic double-sided tape. A third will be attached to the patient's shoe to synchronize the data from the treadmill and the inertial units. Acceleration variability is calculated in post-processing.

Secondary outcomes

  1. Gait Variability Index

    Time frame: At the beginning of the one-day experimental

    A composite score of gait variability based on spatio-temporal parameters, giving an index of gait regularity. The mean reference score is 100, and a score above 100 indicates that the patient is at least as stable as a patient from a healthy population.

  2. Trunk Control Measurement Scale score (TCMS)

    Time frame: At the beginning of the one-day experimental

    The TCMS scale assesses trunk control in the seated position in three dimensions. The maximum (and best) score is 58 points, of which 20 correspond to static balance, 28 to selective movement control and 10 to the ability to perform dynamic extension movements.

  3. Early Clinical Assessment of Balance score

    Time frame: At the beginning of the one-day experimental

    The Early Clinical Assessment of Balance is an evaluative measure used by clinicians to assess balance in the cerebral palsy population. Scoring is on a 0-100 scale where higher scores equate to better balance.

Study contacts

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

Jonathan Pierret, PhD

CONTACT

[email protected]

+33 3 82 52 6761

Sponsors and collaborators

Lead sponsor

Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Other

Registry information

Official study title

Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy

Acronym: VERTEBRAL

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Jan 12, 2026

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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