Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05831696

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

The purpose of this industry-initiated research study is to test that a powered microprocessor controlled knee improves metabolic function during walking in level and sloped conditions as compared to the subject's physician prescribed prosthesis.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Location status: Recruiting

Location contact

Michael Davidson, Ph.D.

CONTACT

[email protected]

909-558-6516

About this study

The Procedures include:

Initial Visit:

  • Informed consent
  • HIPAA authorization
  • Determine/verify ambulation potential
  • Take and record body measurements (height, weight, circumferences)
  • Activities-Specific Balance Confidence (ABC) scale
  • L.A.S.A.R. Posture alignment assessment with RxPx

Second Visit

  • Fit with heartrate monitor and metabolic analyzer mask
  • Treadmill Test (level-ground) with RxPx
  • Rest
  • Treadmill Test (incline) with RxPx
  • Fit subject with PMPK
  • L.A.S.A.R. Posture alignment assessment with PMPK
  • Subject uses PMPK for one week as their primary prosthesis

Third Visit (1 week later)

  • Fit with heartrate monitor and metabolic analyzer mask
  • Treadmill Test (level-ground) with PMPK
  • Rest
  • Treadmill Test (incline) with PMPK
  • Activities-Specific Balance Confidence (ABC) scale
  • Return PMPK and refit of RxPx
  • Verify alignment with L.A.S.A.R. Posture alignment
  • Check that all fasteners are secure

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
  • a body mass greater than 49Kg and less than 117Kg
  • 18-75 years of age
  • Have an ambulation potential of K3 or K4
  • Use a prosthesis daily for walking or sports activities
  • No less than six months of experience with a prosthesis
  • No socket issues or changes in the last six weeks
  • No residual limb pain affecting functional ability.

Exclusion criteria

  • Cannot walk at different speeds (MCFL K0-K2)
  • Limb-loss below the knee or through the hip
  • More than one amputation.
  • Uses an assistive device for walking
  • Uncontrolled edema in leg compartments
  • Compromised skin of the residual limb or contralateral foot
  • Are 180 days or less post-amputation
  • Pregnant (self-reported)

Treatment and study plan

Powered Microprocessor-controlled Knee (PMPK)

Other

A microprocessor-controlled Knee with standardized commercial prosthetic foot

Other names: Power Knee

Primary outcomes

  1. VO2 uptake - level ground

    Time frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment)

    VO2 uptake during ambulation on a treadmill - level ground

  2. VO2 uptake - incline

    Time frame: Visit 2 (3 weeks post-study enrollment)

    VO2 uptake during ambulation on a treadmill - 5 degree incline

Secondary outcomes

  1. Balance confidence

    Time frame: At Baseline Visit (study enrollment)

    Activities based balance confidence survey (0-100%) higher score means more balance confidence

  2. Exertion

    Time frame: Change between Visit 2 (3 weeks post-study enrollment) and Visit 3 (4 weeks post-study enrollment)

    Borg Exertion Scale (0-10) with 10 being maximum exertion

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Davidson, Ph.D.

CONTACT

[email protected]

9095586516

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Össur Iceland ehf

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.