Using Virtual Reality to Help Lower Limb Amputees with Walking
Virtual Reality Applied to the Evaluation and Rehabilitation of Locomotion - Study of Tolerance in the Lower Limb Amputee
This study is testing whether using Virtual Reality can help people with one leg amputated improve their walking and feel more confident.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05635799 on ClinicalTrials.gov |
What this trial studies
This study explores the use of Virtual Reality (VR) to enhance the evaluation and rehabilitation of walking in individuals with unilateral lower limb amputations. By simulating real-life scenarios such as walking on flat ground and slopes, the study aims to assess how these immersive environments can improve gait patterns and overall rehabilitation outcomes. Participants will undergo various assessments, including walking analysis and anxiety evaluations, to measure the effectiveness of the VR approach in promoting autonomy and reducing fall risks. The goal is to optimize rehabilitation practices for amputees through innovative technology.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 79 with unilateral transfemoral or transtibial amputations who can understand simple commands.
Not a fit: Patients who are not able to provide consent, are pregnant, or have severe locomotor disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the rehabilitation process for lower limb amputees, enhancing their mobility and independence.
How similar studies have performed: While the use of VR in rehabilitation is gaining traction, this specific application for lower limb amputees is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Paul ORNETTI
- Email: paul.ornetti@chu-dijon.fr
- Phone: 0380293872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.