Hybrid Pump Technology

Not Applicable

Recruiting

• Conditions: Amputation
• Interventions: Other: Pump prototype

• Registration Number: NCT04230512
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-04-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Unlocked	Pump prototype	The prototype mechanical system is free to compress normally
Locked	Pump prototype	The prototype mechanical system is locked from compressing

Primary Outcome Measures

Name	Time	Method
Socket-reaction moments	Immediate	Moments (torques) generated at the prosthetic socket end during walking

Secondary Outcome Measures

Name	Time	Method
Socket Comfort	Immediate	Comfort of the prosthetic socket
Perceived mobility capability	Immediate	Mobility capability as reported by the participant

Trial Locations

Locations (1)

Jesse Brown VA Medical Center, Chicago, IL; 🇺🇸 Chicago, Illinois, United States