Recruiting

Passive vs. Powered Prosthetic

Sponsor:

Loma Linda University

Code:

NCT05831696

Conditions

Transfemoral Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Powered Microprocessor-controlled Knee (PMPK)

Study Details

Brief summary:

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.

Conditions

Transfemoral Amputation

Study ID

NCT05831696

Start date

Feb 27, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Powered Microprocessor-controlled Knee (PMPK)

the "Power Knee" is a commercially available PMPK.

Interventions

Powered Microprocessor-controlled Knee (PMPK)

A microprocessor-controlled Knee with standardized commercial prosthetic foot

Primary outcome measure

  • VO2 uptake - level ground [ Time Frame: Change between Baseline Visit (study enrollment) and Visit 2 (3 weeks post-study enrollment) ]
  • VO2 uptake - incline [ Time Frame: Visit 2 (3 weeks post-study enrollment) ]

Central Contacts and Locations

Central contacts

Michael Davidson, Ph.D.

9095586516mdavidson@llu.edu

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Michael Davidson, Ph.D.

909-558-6516mdavidson@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Power Knee
  • Amputation
  • Metabolic Costs
  • Heart Rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-02-04.