NCT06138925 Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy
| NCT ID | NCT06138925 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Cerebral Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-01-31 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 & Investigator
Frequently Asked Questions
Who can join the NCT06138925 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06138925 currently recruiting?
Yes, NCT06138925 is actively recruiting participants. Contact the research team at paul.ornetti@chu-dijon.fr for enrollment information.
Where is the NCT06138925 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT06138925 clinical trial?
NCT06138925 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 80 participants.
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