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

NCT04230512 | Completed

• 2 other identifiers: A3090-RRX003090-01A2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

Amputation; Prosthesis; Gait; Leg

Outcome Measures

Primary Outcomes (1)

• Socket-reaction moments

  Maximum moment (torques) generated at the prosthetic socket end during walking

  Immediate

Secondary Outcomes (2)

• Socket Comfort

  Immediate

• Perceived mobility capability

  Immediate

Study Arms (2)

Locked

EXPERIMENTAL

The prototype mechanical system is locked from compressing

Other: Pump prototype

Unlocked

EXPERIMENTAL

The prototype mechanical system is free to compress normally

Other: Pump prototype

Interventions

Pump prototype OTHER

Effects of pump function on gait

Locked; Unlocked

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pathologies aside from amputation or taking medicine that would influence walking or balance
• Poor prosthetic fit or poor residual limb sensation

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Study Officials

• Matthew J. Major, PhD

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomly assigned conditions of pump function to characterize the effects of added movement on socket-reaction torques

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: January 18, 2020
• Study Start: April 4, 2020
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)