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Impact of Powered Knee-Ankle Prosthesis Leg on Everyday Community Mobility and Social Interaction

NCT03204513 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-04-22

No results posted yet for this study

Summary

The overall goal of this research is to determine the efficacy of new powered prosthetic devices for individuals with transfemoral amputations. The anticipation is that this will be a high-impact technological intervention with the potential to restore significant functionality to individuals with lower limb amputation and transform the field of lower limb prosthetics. The objective of the proposed clinical trial is to fully evaluate the biomechanical and energetic effects of using PKA prosthesis and quantify functional performance and quality of life changes.

Conditions

  • Transfemoral Amputees

Interventions

DEVICE

Vanderbilt Powered Knee-Ankle Prosthesis

The Vanderbilt powered prosthesis is a transfemoral prosthesis with powered and coordinated knee and ankle joints. The Generation 3 prosthesis is actuated by two brushless direct current (DC) motors, providing up to 100 Nm of torque at the knee joint, and with the assistance of a parallel stiffness, up to 200 Nm in plantar flexion at the ankle. Sensors measure knee and ankle joint angles, axial load in the shank, and position and orientation of the prosthesis in space (via a 6-axis inertial measurement unit). An onboard lithium-ion battery provides sufficient energy for approximately 10,000 steps between battery charges. The prosthesis prototype weighs approximately 4.3 kg (9.5 lb), the mass of which is approximately equivalent to the intact limb of a 48 kg (105 lb) person.

DEVICE

Microprocessor (MP) Knee Prosthesis

Participants enrolled will already have their own microprocessor controlled (MP) non-powered knee prostheses as per inclusion criteria. Examples: OttoBock's C-Leg, Ossur's Rheo, Freedom Plie, Endolite Orion,etc.

Sponsors & Collaborators

  • Shirley Ryan AbilityLab

    lead OTHER

Principal Investigators

  • Arun Jayaraman, PT, PhD · Shirley Ryan AbilityLab

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204513 on ClinicalTrials.gov