RECRUITING

LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for 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 LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling global reach through the use of digital technologies to solve the worldwide prosthetic accessibility crisis. This is a single-site, Phase I, Clinical Research Study to test the effectiveness and safety of the LIMBER UniLeg. One study group of 30 participants involved for two months using a non-inferiority design in which the participant will be assessed using their normal device (1 month) and the study device (1 month).

Official Title

LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees

Quick Facts

Study Start:2023-12-20
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06648798

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. 1. Provision of signed and dated informed consent form.
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 3. Persons, aged 18 to 75
  4. 4. In good general health as determined by clinical site monitor
  5. 5. Weight \< 125kg
  6. 6. Are not diabetic (self reported)
  7. 7. Be a unilateral transtibial amputee of more than 1 year since amputation
  8. 8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
  9. 9. Live in the Southern California region (within 50 miles of UCSD)
  10. 10. Has sufficient sensation in residual limb as tested by the clinical site monitor
  11. 11. Agreement to adhere to Lifestyle Considerations throughout study duration 11a. Use the testing device (EPD or UniLeg) only during the testing periods. 11b. Walk at least 14,000 steps per week (average of 1 mile per day). 11c. Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, etc.)
  1. 1. Not currently using a prosthetic device
  2. 2. Prosthetic device with active motors, sensors, etc.
  3. 3. Pregnancy (due to fall risk)
  4. 4. Diabetic (due to poor limb sensation), self reported
  5. 5. No under 18 (due to inability to consent)
  6. 6. No over 75 (due to fall risk)
  7. 7. Poor proprioception or sensation at the residual limb

Contacts and Locations

Study Contact

David Wing, MS
CONTACT
8585349315
dwing@health.ucsd.edu
Michael Higgins, MS
CONTACT
8585349315
mdhiggins@health.ucsd.edu

Principal Investigator

Herb Barrack, CPO
PRINCIPAL_INVESTIGATOR
LIMBER Prosthetics & Orthotics Inc

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92093
United States
Limber Prosthetics & Orthotics Inc
San Diego, California, 92111
United States

Collaborators and Investigators

Sponsor: LIMBER Prosthetics & Orthotics Inc

  • Herb Barrack, CPO, PRINCIPAL_INVESTIGATOR, LIMBER Prosthetics & Orthotics 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 Date2023-12-20
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2026-10-31

Terms related to this study

Keywords Provided by Researchers

  • Prosthesis
  • Trans-tibial amputation
  • Limber Unileg
  • 3D Printed

Additional Relevant MeSH Terms

  • Amputation of Lower Limb
  • Prosthesis
  • Non-inferiority Trial of Prothesis