NCT06138925

Brief Summary

Cerebral palsy (CP) is currently one of the major causes of disability in children. The presence of various disorders (muscle stiffness, architectural bone defects, spasticity) leads to a number of functional impacts, including severe impairment of mobility, particularly locomotion. Locomotion can be assessed using a motion capture system that enables 3-dimensional analysis, in order to help make treatment decisions and quantify them. Although these systems are currently considered to be the gold standard, the fact remains that they cause a certain amount of patient fatigue (long set-up times) and that walking is assessed in a laboratory rather than in real life. Today, technological advances have brought to the fore other gait analysis devices, such as inertial measurement units (IMUs). Various systems incorporating IMUs in the feet, for example, respond to these problems of analysing walking in real-life situations. The IMUs record the movements and orientation of the foot in space; the data is then processed by algorithms to recognise walking steps and calculate the spatio-temporal parameters of locomotion. Additional IMUs positioned on the body can be grafted onto this system to provide a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. However, before such devices can be used in a pathological paediatric population, they must be validated in a healthy population. This validation must be conducted using a precise method that has been widely documented in the COSMIN recommendations (Consensus-based Standards for the selection of health Measurement Instruments). The first stage will assess the safety of the IMU devices in a healthy paediatric population, and the validity of the spatio-temporal parameters. If these properties are deemed to be compliant, these same parameters will be assessed in a paediatric population with cerebral palsy in the second stage.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Jan 2028

First Submitted

Initial submission to the registry

November 14, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.9 years

First QC Date

November 14, 2023

Last Update Submit

March 23, 2026

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Walking speed

    participants' walking speed measured jointly by an IMU system in the shoe and a 3D locomotion analysis system

    During the study visit

Study Arms (2)

healthy children

ACTIVE COMPARATOR
Other: Analysis of walkingOther: Analysis of running

hildren with cerebral palsy

EXPERIMENTAL
Other: Analysis of walking

Interventions

Analysis of walkingOTHER

3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at different speeds (slow, comfortable and fast)

healthy children
Analysis of runningOTHER

analysis of running on flat ground at different speeds (comfortable and fast)

healthy children

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who have given their consent and whose legal representatives have given their consent
  • Age between 7 and 17 years,
  • Children able to understand simple commands and instructions.
  • Children living within a maximum radius of 50 km of the investigation site.
  • Child covered by national health insurance.
  • PATIENT GROUP (IN ADDITION TO THOSE ABOVE)
  • Children with proven cerebral palsy resulting in locomotor impairment but able to move around without technical aids (cane, wheelchair).
  • Child covered by national health insurance.

You may not qualify if:

  • Children with a condition other than cerebral palsy that affects their ability to walk.
  • Child subject to a measure of legal protection
  • A child unable to give consent
  • Pregnant, parturient or breast-feeding participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Paul ORNETTI

CONTACT

03 80 29 38 72paul.ornetti@chu-dijon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2023

First Posted

November 18, 2023

Study Start

January 31, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

FR(1)