Hybrid Pump Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets

Conditions
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Amputation

Intervention / Treatment
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* Other: Pump prototype


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomly assigned conditions of pump function to characterize the effects of added movement on socket-reaction torques
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Locked<br>The prototype mechanical system is locked from compressing | Other: Pump prototype<br>* Effects of pump function on gait<br>|
| Experimental: Unlocked<br>The prototype mechanical system is free to compress normally | Other: Pump prototype<br>* Effects of pump function on gait<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socket-reaction moments | Moments (torques) generated at the prosthetic socket end during walking | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socket Comfort | Comfort of the prosthetic socket | Immediate | 
| Perceived mobility capability | Mobility capability as reported by the participant | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputation, Prosthesis, Gait, Leg