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CompletedNCT05635799REVAUpdated Dec 23, 2025

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

An interventional study of Analysis of walking on flat ground and Hospital Anxiety Disorder Questionnaire in Unilateral Amputation of the Lower Limb, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.

Sponsored by Centre Hospitalier Universitaire Dijon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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
02

Conditions studied

  • Unilateral Amputation of the Lower Limb
03

In context

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Subjects with lower limb amputations

    Other: Analysis of walking on flat ground · Other: Hospital Anxiety Disorder Questionnaire · Other: Analysis of walking on slopes · Other: Group interview with a sociologist

  • Active comparator
    Healthy volunteers

    Other: Analysis of walking on flat ground · Other: Hospital Anxiety Disorder Questionnaire · Other: Analysis of walking on slopes

Interventions

  • OtherAnalysis of walking on flat ground

    Analysis of walking on flat ground under different environmental conditions (visit 1)

  • OtherHospital Anxiety Disorder Questionnaire

    performed during the inclusion visit

  • OtherAnalysis 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

  • OtherGroup interview with a sociologist

    Virtual reality feedback, accompanied by a confrontation of the patients' subjective experiences (group of 5 to 10 people)

06

What researchers measure

Primary outcomes

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

    Time frame: at baseline

07

Study locations

1 site
  • Chu Dijon Bourgogne
    Dijon, 21000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05635799
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Dec 2, 2022
Start date
Apr 6, 2023
Primary completion
Nov 26, 2025
Completion
Nov 26, 2025
Last update
Dec 23, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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