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Search / Trial NCT05831696

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

Launched by LOMA LINDA UNIVERSITY · Apr 14, 2023

Trial Information

Current as of September 12, 2025

Recruiting

Keywords

Power Knee Amputation Metabolic Costs Heart Rate

ClinConnect Summary

This clinical trial is studying how a new type of prosthetic knee, which is powered by a microprocessor, affects walking ability for individuals who have had a transfemoral amputation (where the leg is amputated above the knee). The goal is to see if this powered knee helps people use less energy while walking on flat surfaces and slopes when compared to their regular, doctor-prescribed prosthetic knee. The trial is currently looking for participants and aims to understand how these different types of prosthetic knees impact walking efficiency.

To be eligible for this study, participants should be between 18 and 75 years old and weigh between 49 and 117 kg. They must have had a transfemoral amputation and be able to walk regularly with a prosthetic knee for at least six months. Participants should be able to walk at higher activity levels (like running or playing sports) and should not have any pain or issues with their residual limb. If you meet these criteria and are interested in contributing to this important research, you could help us learn more about how different prosthetic knees can improve walking for people with limb loss.

Gender

ALL

Eligibility criteria

  • 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)

About Loma Linda University

Loma Linda University is a prominent academic institution dedicated to advancing health and wellness through innovative research and education. As a sponsor of clinical trials, Loma Linda University leverages its extensive medical and scientific expertise to conduct rigorous studies aimed at improving patient outcomes and public health. With a commitment to ethical practices and patient safety, the university collaborates with a diverse network of healthcare professionals and researchers to explore novel therapeutic interventions and enhance clinical knowledge across various medical disciplines. Through its clinical trials, Loma Linda University seeks to contribute valuable insights to the medical community and foster advancements in healthcare delivery.

Locations

Loma Linda, California, United States

Patients applied

0 patients applied

Trial Officials

Michael Davidson, Ph.D.

Principal Investigator

Loma Linda University Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported