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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06320288
Acronym
VERTEBRAL
Enrollment
270
Registered
2024-03-20
Start date
2023-09-20
Completion date
2028-09-30
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children With Cerebral Palsy

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Trunk and center-of-mass accelerations and acceleration variabilityAt the end of the one-day experimentalIn 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

MeasureTime frameDescription
Gait Variability IndexAt the beginning of the one-day experimentalA 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.
Trunk Control Measurement Scale score (TCMS)At the beginning of the one-day experimentalThe 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.
Early Clinical Assessment of Balance scoreAt the beginning of the one-day experimentalThe 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.

Countries

France

Contacts

Primary ContactJonathan Pierret, PhD
jonathan.pierret@ugecam.assurance-maladie.fr+33 3 82 52 6761

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026