Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— KAPP-IMU anc  

Official title:

Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138925
• Other study ID #: ORNETTI 2023
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Paul ORNETTI
• Phone: 03 80 29 38 72
• Email: paul.ornetti[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Analysis of walking
3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at different speeds (slow, comfortable and fast)
• Analysis of running
analysis of running on flat ground at different speeds (comfortable and fast)
• Analysis of walking
3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at spontaneous speed (comfortable).

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	participants' walking speed measured jointly by an IMU system in the shoe and a 3D locomotion analysis system	During the study visit