NCT05635799

Virtual Reality Applied to the Evaluation and Rehabilitation of Locomotion - Study of Tolerance in the Lower Limb Amputee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Centre Hospitalier Universitaire Dijon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The adaptability of the locomotor activity allows to face all the modifications of the immediate environment met in the daily activities. These situations become complex to apprehend for a person with a locomotor disability such as patients fitted with a lower limb amputation device. Thus, these adaptation capacities are essential to take into account in the rehabilitation process to maximize autonomy and reduce the risk of falls. For this purpose, the Quantitative Gait Analysis (QGA) allows to measure the impact of these constraining situations on the organization of gait patterns. However, this evaluation could be considerably optimized in current practice with the contribution of Virtual Reality (VR), by its immersive power which brings it closer to real life conditions (walking in a straight line, going up/down steps, taking into account visual and sound constraints, etc.). Eventually, this immersive approach by various VR environments could allow to improve the rehabilitation protocols in a personalized and secure way. In this context, this project proposes to measure the tolerance of volunteers in a specific virtual environment and to quantify the modifications induced by this immersive environment, during a simple locomotor act (walking on flat ground) and complex (walking on a slope) in healthy volunteers, in order to evaluate the impact of VR on locomotion in a healthy population, and then in a second time in lower limb amputee patients This monocentric study will take place on the Technological Investigation Platform of the Dijon Bourgogne University Hospital. 25 healthy volunteers and 25 lower limb amputees (transtibial or transfemoral) will be included in this study. The participants will make 3 visits: * Visit 1 (inclusion visit and analysis of walking on flat ground) * visit 2 (analysis of walking on slopes): between 15 days and 1 month after visit 1 * visit 3 (group interview with a sociologist): only for patients within 45 days after visit 2

Conditions

• Unilateral Amputation of the Lower Limb

Interventions

Type	Name	Description
OTHER	Analysis of walking on flat ground	Analysis of walking on flat ground under different environmental conditions (visit 1)
OTHER	Hospital Anxiety Disorder Questionnaire	performed during the inclusion visit
OTHER	Analysis of walking on slopes	All assessments will be identical to the flat walking analysis: flat walking will be replaced by slope walking for all environmental conditions
OTHER	Group interview with a sociologist	Virtual reality feedback, accompanied by a confrontation of the patients' subjective experiences (group of 5 to 10 people)

Timeline

• Start date: 2023-04-06
• Primary completion: 2025-11-26
• Completion: 2025-11-26
• First posted: 2022-12-02
• Last updated: 2025-12-23

Locations

1 site across 1 country: France