LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Recruiting now · Not applicable
Conditions studied: Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
In brief
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).
Key facts
- Study ID
- NCT06648798
- Run by
- LIMBER Prosthetics & Orthotics Inc
- People needed
- 30
- Starts
- 2023-12-20
- Expected to finish
- 2026-10-31
- Last updated by the study team
- 2024-11-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Persons, aged 18 to 75
- In good general health as determined by clinical site monitor
- Weight < 125kg
- Are not diabetic (self reported)
- Be a unilateral transtibial amputee of more than 1 year since amputation
- Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
- Live in the Southern California region (within 50 miles of UCSD)
- Has sufficient sensation in residual limb as tested by the clinical site monitor
- 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.)
You may not qualify if…
- Not currently using a prosthetic device
- Prosthetic device with active motors, sensors, etc.
- Pregnancy (due to fall risk)
- Diabetic (due to poor limb sensation), self reported
- No under 18 (due to inability to consent)
- No over 75 (due to fall risk)
- Poor proprioception or sensation at the residual limb
Where it is running
- University of California San Diego — La Jolla, California, United States (enrolling)
- Limber Prosthetics & Orthotics Inc — San Diego, California, United States (enrolling)
Full record on ClinicalTrials.gov
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