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

Children With Cerebral Palsy Clinical Trial

— VERTEBRAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320288
• Other study ID #: IRR-FLAVIGNY-2023-1
• Status: Recruiting
• Start date: September 20, 2023
• Est. completion date: September 2028

Study information

• Verified date: March 2024
• Source: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
• Contact: Jonathan Pierret, PhD
• Phone: +33 3 82 52 6761
• Email: jonathan.pierret[@]ugecam.assurance-maladie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: September 2028
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children With Cerebral Palsy

Locations

Country	Name	City	State
France	Institut Régional de Médecine Physique et de Réadaptation	Nancy

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gait Variability Index	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.	At the beginning of the one-day experimental
Secondary	Trunk Control Measurement Scale score (TCMS)	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.	At the beginning of the one-day experimental
Secondary	Early Clinical Assessment of Balance score	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.	At the beginning of the one-day experimental