Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID05831696

Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss

Led by Loma Linda University · Updated on 2026-02-04

12

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

L

Loma Linda University

Lead Sponsor

Ö

Össur Iceland ehf

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying individuals with transfemoral or knee disarticulation amputations to compare the metabolic effects of walking with a powered microprocessor-controlled knee (PMPK) versus their usual prosthesis. The goal is to see if using the PMPK improves walking efficiency on level ground and inclines. This research aims to explore how advanced prosthetic technology may impact metabolic function during walking. Participants will undergo a series of visits beginning with an initial assessment, including consent, body measurements, and balance confidence evaluation. During the second visit, participants will be fitted with a heart rate monitor and metabolic analyzer mask to complete treadmill walking tests on level and inclined surfaces using their usual prosthesis. They will then be fitted with the powered knee to use as their main prosthesis for one week. The third visit repeats the treadmill tests with the powered knee, followed by assessments and refitting with their original prosthesis. Throughout the study, participants will be assessed for oxygen uptake during walking on level ground and inclines, as well as balance confidence and exertion levels. Researchers will monitor alignment and prosthesis fit and ensure participant safety by checking for secure fasteners. The study involves a total duration of about four weeks, with careful tracking of metabolic and functional outcomes related to walking with different prosthetic knees.

CONDITIONS

Brief Title

Metabolic Cost of Walking With Passive vs. Powered Prosthetic Knees Among Persons With Limb Loss

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females with unilateral knee disarticulation or transfemoral amputation
  • Body mass greater than 49 kg and less than 117 kg
  • Age between 18 and 75 years
  • Ambulation potential of K3 or K4
  • Use a prosthesis daily for walking or sports activities
  • At least six months of experience with a prosthesis
  • No socket issues or changes in the last six weeks
  • No residual limb pain affecting functional ability
Not Eligible

You will not qualify if you...

  • Unable to walk at different speeds (MCFL K0-K2)
  • Limb loss below the knee or through the hip
  • More than one amputation
  • Use of an assistive device for walking
  • Uncontrolled edema in leg compartments
  • Compromised skin of the residual limb or contralateral foot
  • 180 days or less post-amputation
  • Pregnant (self-reported)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants complete initial assessments including body measurements, balance confidence scale, and posture alignment with their current prosthetic knee.

1 visit (in-person)

Treatment

Duration - 1 week

Participants undergo treadmill tests with their current prosthetic knee and then use the powered microprocessor-controlled knee (PMPK) as their primary prosthesis for one week.

1 visit to fit PMPK and treadmill tests, then 1 week of using PMPK

Follow-up Assessment

Duration - 1 day

Participants complete treadmill tests and balance confidence assessments with the PMPK, then return to their original prosthetic knee and verify alignment.

1 visit (in-person) one week after PMPK fitting

Trial Site Locations

Total: 1 location

1

Loma Linda University

Loma Linda, California, United States, 92354

Actively Recruiting

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Research Team

M

Michael Davidson, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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