Amputation of Lower LimbProsthesisNon-inferiority Trial of Prothesis
Investigational drug(s) / intervention(s)
Limber Limb
Limber Limb: Participants will be 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).
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Persons, aged 18 to 75
4. In good general health as determined by clinical site monitor
5. Weight \< 125kg
6. Are not diabetic (self reported)
7. Be a unilateral transtibial amputee of more than 1 year since amputation
8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
9. Live in the Southern California region (within 50 miles of UCSD)
10. Has sufficient sensation in residual limb as tested by the clinical site monitor
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.)
Exclusion Criteria:
1. Not currently using a prosthetic device
2. Prosthetic device with active motors, sensors, etc.
3. Pregnancy (due to fall risk)
4. Diabetic (due to poor limb sensation), self reported
5. No under 18 (due to inability to consent)
6. No over 75 (due to fall risk)
7. Poor proprioception or sensation at the residual limb
Primary outcome measure(s)
Mobility - 6min walk — Baseline, 4weeks, 8 weeks Measure total distance for a timed six-min walk test for both the Limber UniLeg vs. existing prosthetic devices.
Mobility - Timed-Up-and-Go — Baseline, 4weeks, 8 weeks Measure time for the timed up and go (TUG) test for both the Limber UniLeg vs. existing prosthetic devices.
Mobility--25 foot walk — All visits (Baseline, 4 weeks, 8 weeks) Time to cover 25 feet walking at a normal speed
Trial sites (2)
Facility
City
Region
Status
University of California San Diego
La Jolla
California
Recruiting
Limber Prosthetics & Orthotics Inc
San Diego
California
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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