Testing a new vacuum pump for prosthetic limbs
Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets
This study tests a new vacuum pump for prosthetic limbs to see if it can make walking easier and more comfortable for amputees.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04230512 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new pump design that creates a vacuum between the prosthetic socket and the amputated limb to improve mobility and limb health. Participants will engage in a series of walking tests on a treadmill while using the prototype pump under two different conditions. The study aims to gather data on socket comfort and mobility capabilities, measuring the effectiveness of the pump in real-time. The goal is to determine if this innovative approach can enhance the experience of prosthesis users.
Who should consider this trial
Good fit: Ideal candidates are individuals with a lower limb amputation who have been using a definitive prosthesis for at least six months and can walk independently.
Not a fit: Patients with poor prosthetic fit, poor residual limb sensation, or other pathologies affecting walking or balance may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly improve the comfort and mobility of individuals using prosthetic limbs.
How similar studies have performed: While similar approaches have been explored, this specific vacuum pump technology is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to stand quietly and walk for 10 minutes continuously without an assistive device (e.g. cane or walker) and without undue fatigue or health risks * Pre-classified clinically to be at least a limited community ambulator of Medicare Functional Classification Level (K)2 * Residual limb in good health * At least six months experience with a definitive prosthesis that utilizes vacuum assisted suspension Exclusion Criteria: * Pathologies aside from amputation or taking medicine that would influence walking or balance * Poor prosthetic fit or poor residual limb sensation
Where this trial is running
Chicago, Illinois
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Matthew J. Major, PhD — Jesse Brown VA Medical Center, Chicago, IL
- Study coordinator: Matthew J Major, PhD
- Email: Matthew.Major2@va.gov
- Phone: (312) 569-6166
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.