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

Launched by LIMBER PROSTHETICS & ORTHOTICS INC · Oct 17, 2024

Keywords

ClinConnect Summary

The LIMBER UniLeg trial is studying a new type of prosthetic leg designed for people who have lost a leg below the knee. This prosthetic is made using 3D printing, which means it can be produced faster and at a lower cost compared to traditional prosthetics. The goal of the trial is to see if the LIMBER UniLeg works as well as regular prosthetic legs that don’t have motors or sensors. Participants will use their usual prosthetic for one month and then switch to the LIMBER UniLeg for another month to compare their experiences.

To join the study, participants need to be between 18 and 75 years old, have been living with a below-knee amputation for at least a year, and currently use a passive (non-motorized) prosthetic. They should be in good health and able to walk at least a mile a day. This trial is taking place in the Southern California area, and participants will need to commit to following specific guidelines about their activity and diet during the study. Overall, this research aims to improve access to prosthetic limbs for amputees around the world.

Gender

ALL

Eligibility criteria

• 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