Amputation
Conditions
Keywords
Amputation, Prosthesis, Gait, Leg
Brief summary
Prostheses can be suspended from the amputated limb using a variety of techniques, such as straps and suction. Suspending the prosthesis by creating a vacuum between the prosthetic socket and limb using a pump has benefits over other techniques including improved limb health and mobility. A new pump design will be tested by prosthesis users in the laboratory to verify its functionality during walking.
Detailed description
Human subject testing will involve a cross-sectional, repeated measures study consisting of a single 3 hour visit wherein participants will initially stand and then continuously walk at their self-selected speed for ten minutes on a level treadmill with the prototype under two randomly presented conditions of the mechanical system: 1) fully functional, and 2) locked to restrict axial displacement. After written informed consent is obtained, information on socket comfort and mobility capability will be collected. A load-cell will be installed proximal to the prototype and in-line with the prosthesis to measure instantaneous socket-reaction moments.
Interventions
OTHERPump prototype
Effects of pump function on gait
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Randomly assigned conditions of pump function to characterize the effects of added movement on socket-reaction torques
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Socket-reaction moments | Immediate | Maximum moment (torques) generated at the prosthetic socket end during walking |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socket Comfort | Immediate | Comfort of the prosthetic socket |
| Perceived mobility capability | Immediate | Mobility capability as reported by the participant |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew J. Major, PhD
Jesse Brown VA Medical Center, Chicago, IL
Outcome results
None listed