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

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

Study Overview

• Status: Completed
• Conditions: Unilateral Amputation of the Lower Limb
• Intervention / Treatment: Other: Analysis of walking on flat ground; Other: Hospital Anxiety Disorder Questionnaire; Other: Analysis of walking on slopes; Other: Group interview with a sociologist

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 measure
• Pregnant, parturient or breastfeeding woman
• Major incapable or unable to express his consent
• Minor
• Person with locomotor disorders (orthopedic, neurological, vascular, cardiac...) other than amputation that may significantly alter walking
• Persons with contraindications to wearing a virtual reality helmet (uncontrolled epilepsy, wounds in an area that the helmet would cover, severe ophthalmological disorders, etc.)
• Patients unable to participate in a group interview (qualitative study only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers	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
Experimental: Subjects with lower limb amputations	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of healthy volunteers who completed the virtual reality experiment (flat walk) without complications	at baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Actual): November 26, 2025
• Study Completion (Actual): November 26, 2025

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: CASILLAS CRBFC-E 2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No