CompletedNot Applicable

Assessment of a Hybrid Pump for Vacuum Suspension of Prosthetic Sockets for Persons With Lower Limb Loss to Characterize the Effects of Added Movement on Socket-reaction Torques

United States12 participantsStarted 2020-04-04

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Socket-reaction moments

Timeframe: Immediate

Trial details

NCT IDNCT04230512

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-03-31

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