RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-27
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05831696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and Females with unilateral knee disarticulation or transfemoral (KD/TF) amputation.
  2. * a body mass greater than 49Kg and less than 117Kg
  3. * 18-75 years of age
  4. * Have an ambulation potential of K3 or K4
  5. * Use a prosthesis daily for walking or sports activities
  6. * No less than six months of experience with a prosthesis
  7. * No socket issues or changes in the last six weeks
  8. * No residual limb pain affecting functional ability.
  1. * Cannot walk at different speeds (MCFL K0-K2)
  2. * Limb-loss below the knee or through the hip
  3. * More than one amputation.
  4. * Uses an assistive device for walking
  5. * Uncontrolled edema in leg compartments
  6. * Compromised skin of the residual limb or contralateral foot
  7. * Are 180 days or less post-amputation
  8. * Pregnant (self-reported)

Contacts and Locations

Study Contact

Michael Davidson, Ph.D.
CONTACT
9095586516
mdavidson@llu.edu

Principal Investigator

Michael Davidson, Ph.D.
PRINCIPAL_INVESTIGATOR
Loma Linda University Health

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Michael Davidson, Ph.D., PRINCIPAL_INVESTIGATOR, Loma Linda University Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-27
Study Completion Date2025-02

Study Record Updates

Study Start Date2023-02-27
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • Power Knee
  • Amputation
  • Metabolic Costs
  • Heart Rate

Additional Relevant MeSH Terms

  • Transfemoral Amputation