Virtual Reality Applied to the Evaluation and Rehabilitation of Locomotion - Study of Tolerance in the Lower Limb Amputee
NCT ID: NCT05635799
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-04-06
2025-11-26
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Subjects with lower limb amputations
Analysis of walking on flat ground
Analysis of walking on flat ground under different environmental conditions (visit 1)
Hospital Anxiety Disorder Questionnaire
performed during the inclusion visit
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
Group interview with a sociologist
Virtual reality feedback, accompanied by a confrontation of the patients' subjective experiences (group of 5 to 10 people)
Healthy volunteers
Analysis of walking on flat ground
Analysis of walking on flat ground under different environmental conditions (visit 1)
Hospital Anxiety Disorder Questionnaire
performed during the inclusion visit
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
Interventions
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Analysis of walking on flat ground
Analysis of walking on flat ground under different environmental conditions (visit 1)
Hospital Anxiety Disorder Questionnaire
performed during the inclusion visit
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
Group interview with a sociologist
Virtual reality feedback, accompanied by a confrontation of the patients' subjective experiences (group of 5 to 10 people)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Other Identifiers
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CASILLAS CRBFC-E 2019
Identifier Type: -
Identifier Source: org_study_id