RECRUITING

Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees

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 goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.

Official Title

Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations

Quick Facts

Study Start:2023-09-12
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06194838

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Are at least 18 years old
  2. * Transfemoral prosthesis user (limb absence between the knee and hip)
  3. * Current user of a mechanical knee
  4. * Regularly wears prosthesis at least 5 days per week
  5. * Have adequate clearance between distal end and ground for necessary knee and foot components
  6. * Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team
  7. * Socket-Comfort Score: 6 or above to ensure adequate socket fit
  8. * Six months or more experience on a prosthesis
  9. * Body weight between 50kg and 116kg (110lbs - 256lbs)
  10. * Height between 1.2m and 1.95m (47.2in and 76.8in)
  11. * Has a phone to answer periodic study calls
  1. * Present injuries to residual limb or contralateral leg affecting functional ability
  2. * Contralateral amputation proximal to MTP (metatarsophalangeal) joint
  3. * Socket issues/changes in the last 6 weeks
  4. * Users with bone-anchored implants
  5. * Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and/or completing the study

Contacts and Locations

Study Contact

Shane Wurdeman, PhD
CONTACT
402-290-8051
swurdeman@hanger.com
Jennifer Johansson, MS
CONTACT
774-233-0874
jen.johansson@liberatingtech.com

Principal Investigator

Jennifer Johansson, MS
PRINCIPAL_INVESTIGATOR
Liberating Technologies, Inc.

Study Locations (Sites)

Hanger Clinic
Austin, Texas, 78758
United States

Collaborators and Investigators

Sponsor: Liberating Technologies, Inc.

  • Jennifer Johansson, MS, PRINCIPAL_INVESTIGATOR, Liberating Technologies, Inc.

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 Date2023-09-12
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2023-09-12
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • amputee
  • lower limb amputee
  • transfemoral amputee
  • prosthetic knee
  • power knee
  • mechanical knee
  • lower limb prosthesis user

Additional Relevant MeSH Terms

  • Amputation
  • Amputation; Traumatic, Leg, Lower
  • Limb; Absence, Congenital, Lower
  • Prosthesis User
  • Lower Limb Amputation Above Knee (Injury)
  • Amputation; Traumatic, Leg: Thigh, Between Hip and Knee