NCT05104645

Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.

Conditions

• Cerebral Vascular Accident

Interventions

Type	Name	Description
OTHER	Analysis of the walk	Gait analysis in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Patients: S0, S1, S2, S4 and S6 Healthy volunteers: 2 times (between 3 and 20 days apart)
OTHER	Analysis of the race	Analysis of running in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Healthy volunteers: 2 times (between 3 and 20 days apart)
OTHER	Unipodal and bipodal jumps on flat ground	Healthy volunteers: 2 times (between 3 and 20 days apart)

Timeline

• Start date: 2021-09-29
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2021-11-03
• Last updated: 2023-09-13

Locations

1 site across 1 country: France