- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06320288
Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy (VERTEBRAL) (VERTEBRAL)
January 8, 2026 updated by: Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Analysis of Trunk and Center of Mass Control Development During Gait in Children With Cerebral Palsy
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
270
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jonathan Pierret, PhD
- Phone Number: +33 3 82 52 6761
- Email: jonathan.pierret@ugecam.assurance-maladie.fr
Study Locations
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-
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Nancy, France, 54000
- Recruiting
- Institut Régional de Médecine Physique et de Réadaptation
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Contact:
- Jonathan Pierret, PhD
- Phone Number: +33 3 82 52 6761
- Email: jonathan.pierret@ugecam.assurance-maladie.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Children with cerebral palsy
All children will undergo :
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Children with typical development
All children will undergo :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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At the end of the one-day experimental
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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At the beginning of the one-day experimental
|
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Trunk Control Measurement Scale score (TCMS)
Time Frame: At the beginning of the one-day experimental
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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.
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At the beginning of the one-day experimental
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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.
|
At the beginning of the one-day experimental
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 20, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
February 5, 2024
First Submitted That Met QC Criteria
March 12, 2024
First Posted (Actual)
March 20, 2024
Study Record Updates
Last Update Posted (Estimated)
January 12, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-A00505-40
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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