Unilateral Amputation of the Lower LimbREVANCT05635799
Virtual Reality Applied to the Evaluation and Rehabilitation of Locomotion - Study of Tolerance in the Lower Limb Amputee
A study testing Analysis of walking on flat ground, Hospital Anxiety Disorder Questionnaire and Analysis of walking on slopes in people with Unilateral Amputation of the Lower Limb, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Amputation of the Lower Limb
- What is being tested?
- Analysis of walking on flat ground, Hospital Anxiety Disorder Questionnaire and Analysis of walking on slopes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2023to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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
- Being tested
- Analysis of walking on flat ground, Hospital Anxiety Disorder Questionnaire, Analysis of walking on slopes, Group interview with a sociologist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of walking on flat groundOther
Analysis of walking on flat ground under different environmental conditions (visit 1)
Hospital Anxiety Disorder QuestionnaireOther
performed during the inclusion visit
Analysis of walking on slopesOther
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 sociologistOther
Virtual reality feedback, accompanied by a confrontation of the patients' subjective experiences (group of 5 to 10 people)
| Study group | Role | What they receive |
|---|---|---|
| Subjects with lower limb amputations | Experimental | Not described Receives: Other: Analysis of walking on flat ground; Other: Hospital Anxiety Disorder Questionnaire; Other: Analysis of walking on slopes; Other: Group interview with a sociologist |
| Healthy volunteers | Active comparator | Not described Receives: Other: Analysis of walking on flat ground; Other: Hospital Anxiety Disorder Questionnaire; Other: Analysis of walking on slopes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of healthy volunteers who completed the virtual reality experiment (flat walk) without complications
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start6 Apr 2023
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Amputation of the Lower LimbStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635799
- Sponsor's protocol ID
- CASILLAS CRBFC-E 2019
- Acronym
- REVA
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Applied to the Evaluation and Rehabilitation of Locomotion - Study of Tolerance in the Lower Limb Amputee
- ClinicalTrials.gov ID
- NCT05635799
- Acronym / sponsor ID
- REVA / CASILLAS CRBFC-E 2019
- Conditions
- Unilateral Amputation of the Lower Limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with lower limb amputations | Experimental | Other: Analysis of walking on flat ground, Other: Hospital Anxiety Disorder Questionnaire, Other: Analysis of walking on slopes, Other: Group interview with a sociologist |
| Healthy volunteers | Active comparator | Other: Analysis of walking on flat ground, Other: Hospital Anxiety Disorder Questionnaire, Other: Analysis of walking on slopes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Person who has given oral consent
- Male or female over the age of majority, < 80 years
- Person able to understand simple commands, conditioning instructions
- Person who has given oral consent
- Male or female over the age of majority, < 80 years
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of walking on flat groundAnalysis of walking on flat ground under different environmental conditions (visit 1) | Other | Healthy volunteers, Subjects with lower limb amputations |
| Hospital Anxiety Disorder Questionnaireperformed during the inclusion visit | Other | Healthy volunteers, Subjects with lower limb amputations |
| Analysis of walking on slopesAll assessments will be identical to the flat walking analysis: flat walking will be replaced by slope walking for all environmental conditions | Other | Healthy volunteers, Subjects with lower limb amputations |
| Group interview with a sociologistVirtual reality feedback, accompanied by a confrontation of the patients' subjective experiences (group of 5 to 10 people) | Other | Subjects with lower limb amputations |
Primary outcome
Percentage of healthy volunteers who completed the virtual reality experiment (flat walk) without complications
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Related trials for Unilateral Amputation of the Lower Limb
Recruiting
Impact of Footwear on Gait in Unilateral Transtibial Amputees
Transtibial Amputation, Lower Limb Amputation
RecruitingObservational study
Gait and Energy Expenditure in Children With Lower Limb Amputation (MAPEDE)
Amputation of Lower Extremity, All Causes
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of walking on flat ground, Hospital Anxiety Disorder Questionnaire and Analysis of walking on slopes in people with Unilateral Amputation of the Lower Limb, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of healthy volunteers who completed the virtual reality experiment (flat walk) without complications (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.