HIPPI: Hybrid Pump Technology

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Recruiting
• CT.gov ID: NCT04230512
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation	Other: Pump prototype	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Randomly assigned conditions of pump function to characterize the effects of added movement on socket-reaction torquesRandomly assigned conditions of pump function to characterize the effects of added movement on socket-reaction torques
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets
• Actual Study Start Date: Apr 4, 2020
• Anticipated Primary Completion Date: Mar 31, 2023
• Anticipated Study Completion Date: Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Locked The prototype mechanical system is locked from compressing	Other: Pump prototype; Effects of pump function on gait
Experimental: Unlocked The prototype mechanical system is free to compress normally	Other: Pump prototype; Effects of pump function on gait

Outcome Measures

Primary Outcome Measures

1. Socket-reaction moments [Immediate]

   Moments (torques) generated at the prosthetic socket end during walking

Secondary Outcome Measures

1. Socket Comfort [Immediate]

   Comfort of the prosthetic socket

2. Perceived mobility capability [Immediate]

   Mobility capability as reported by the participant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Matthew J. Major, PhD, Jesse Brown VA Medical Center, Chicago, IL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT04230512
• Other Study ID Numbers: A3090-R; RX003090-01A2
• First Posted: Jan 18, 2020
• Last Update Posted: Feb 28, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Amputation; Prosthesis; Gait; Leg

Study Results

No Results Posted as of Feb 28, 2022