Hybrid Pump Technology (HIPPI)

VA Office of Research and Development

Status: Enrolling

Conditions: Amputation

Treatments: Other: Pump prototype

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04230512

RX003090-01A2 (Other Grant/Funding Number)

A3090-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Locked

Experimental group

Description:

The prototype mechanical system is locked from compressing

Treatment:

Other: Pump prototype

Unlocked

Experimental group

Description:

The prototype mechanical system is free to compress normally

Treatment:

Other: Pump prototype