Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Measurement Units. Validation in Healthy Children and Children With Cerebral Palsy (KAPP-IMU anc)

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Analysis of walking; Other: Analysis of running; Other: Analysis of walking

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul ORNETTI; Phone Number: +33 03 80 29 38 72; Email: paul.ornetti@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Mathieu GUEUGNON; Phone Number: +33 03 80 29 38 72; Email: mathieu.gueugnon@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: healthy children	Other: Analysis of walking; 3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at different speeds (slow, comfortable and fast); Other: Analysis of running; analysis of running on flat ground at different speeds (comfortable and fast); Other: Analysis of walking; 3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at spontaneous speed (comfortable).
Experimental: hildren with cerebral palsy	Other: Analysis of walking; 3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at different speeds (slow, comfortable and fast); Other: Analysis of walking; 3-dimensional gait analysis with inertial measurement units (IMUs) on flat ground at spontaneous speed (comfortable).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking speed	participants' walking speed measured jointly by an IMU system in the shoe and a 3D locomotion analysis system	During the study visit

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: ORNETTI 2023

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