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

NCT06320288 | Recruiting

• 1 other identifier: 2023-A00505-40
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Children With Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Trunk and center-of-mass accelerations and acceleration variability

  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.

  At the end of the one-day experimental

Secondary Outcomes (3)

• Gait Variability Index

  At the beginning of the one-day experimental

• Trunk Control Measurement Scale score (TCMS)

  At the beginning of the one-day experimental

• Early Clinical Assessment of Balance score

  At the beginning of the one-day experimental

Study Arms (2)

Children with cerebral palsy

All children will undergo : * A neuro-articular assessment * A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking. * Assessment of gross motor function * Static posturography * Functional assessment of the trunk * Functional assessment of balance

Children with typical development

All children will undergo : * A neuro-articular assessment * A gait analysis on a walking track and with three inertial units to analyze the behavior of their trunk and center of mass during walking. * Static posturography * Functional assessment of the trunk * Functional assessment of balance

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with cerebral palsy presenting gait pattern disorders receive consultation and/or care (day or full hospitalization) at the Flavigny-sur-Moselle CMPRE.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institut Régional de Médecine Physique et de Réadaptation

Nancy, 54000, France

RECRUITING

Central Study Contacts

Jonathan Pierret, PhD

CONTACT

+33 3 82 52 6761; jonathan.pierret@ugecam.assurance-maladie.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 20, 2024
• Study Start: September 20, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

FR (1)