Understanding how amputees navigate slopes and stairs with prostheses
Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations
This study looks at how people with lower limb amputations use different types of prosthetic legs to walk up and down stairs and slopes to help improve future prosthetic designs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT04030650 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with lower limb amputations who use various types of prostheses, including mechanical and electronic options. It aims to analyze how these patients anticipate and manage the challenges of climbing and descending stairs and slopes, which can be particularly complex due to the absence of certain muscle functions. The study will involve functional analyses and 3D assessments of walking and balance to better understand locomotor expectations in these scenarios. The ultimate goal is to inform the development of more advanced prosthetic technologies that can assist amputees in navigating their environments more effectively.
Who should consider this trial
Good fit: Ideal candidates include adults with unilateral major lower limb amputations who have been using their prostheses for at least three months.
Not a fit: Patients with conditions or disabilities other than amputation that affect walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prosthetic designs that enhance mobility and safety for amputees in challenging environments.
How similar studies have performed: While the approach of analyzing locomotor expectations in amputees is innovative, similar studies have shown promise in improving prosthetic technology and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Healthy volunteers: * person who has given oral consent * male or female adult * person being able to understand simple orders, locomotion instructions Lower limb amputee patients: * person who has given oral consent * male or female adult * patient with unilateral major lower limb amputation of any origin (traumatic, vascular, infectious, congenital or neoplastic) with definitive equipment used routinely for at least 3 months. * person able to understand simple orders, locomotion instructions Exclusion Criteria: * person not affiliated or not benefiting from a heath insurance system * person subject to a legal protection measure (curatorship, guardianship) * person with a legal guardian * pregnant or breastfeeding woman * adult unable to consent * person with a dislocated hip * subject with conditions or disabilities other than amputation that affect walking
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: 0380293745
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.