CompletedNot Applicable

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

France70 participantsStarted 2023-04-06

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Healthy volunteers: * Person who has given oral consent * Male or female over the age of majority, \< 80 years * Person able to understand simple commands, conditioning instructions Amputee patients: * Person who has given oral consent * Male or female over the age of majority, \< 80 years * Patients with unilateral transfemoral or transtibial amputation of the lower limb of any origin (traumatic, vascular, congenital or neoplastic) with a definitive device. * Patients with stable locomotion with aids, without technical aids * Person able to understand simple orders, conditioning instructions Exclusion Criteria: Healthy Volunteers: * Person who is not affiliated or not a beneficiary of a social security system * Person subject to a legal protection measure (curatorship, guardianship) * Person subject to a legal protection measure * Pregnant, parturient or breastfeeding woman * Major incapable or unable to express his consent * Minor * Person with locomotor disorders (orthopedic, neurological, vascular, cardiac...) and/or balance disorders that may significantly alter walking * Person with a contraindication to wearing a virtual reality helmet (uncontrolled epilepsy, wound of an area that the helmet would cover, severe ophthalmological disorders etc.) Amputee patients: * Person who is not affiliated or not a beneficiary of a social security plan * Person under legal protection (guardianship, trusteeship) * Person subject to a legal protection measu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of healthy volunteers who completed the virtual reality experiment (flat walk) without complications

Timeframe: at baseline

Trial details

NCT IDNCT05635799

SponsorCentre Hospitalier Universitaire Dijon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-26

View on ClinicalTrials.gov More Unilateral Amputation of the Lower Limb trials