Hybrid Pump Technology

Amputation Clinical Trial

— HIPPI  

Official title:

Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04230512
• Other study ID #: A3090-R
• Secondary ID: RX003090-01A2
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2020
• Est. completion date: September 29, 2024

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Matthew J Major, PhD
• Phone: (312) 569-6166
• Email: Matthew.Major2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• Pump prototype
Effects of pump function on gait

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Socket-reaction moments	Moments (torques) generated at the prosthetic socket end during walking	Immediate
Secondary	Socket Comfort	Comfort of the prosthetic socket	Immediate
Secondary	Perceived mobility capability	Mobility capability as reported by the participant	Immediate