Actively Recruiting
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Led by LIMBER Prosthetics & Orthotics Inc · Updated on 2024-11-26
30
Participants Needed
2
Research Sites
149 weeks
Total Duration
On this page
Sponsors
L
LIMBER Prosthetics & Orthotics Inc
Lead Sponsor
U
University of California, San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willing to comply with all study procedures and available for the entire study duration
- Age between 18 and 75 years
- In good general health as determined by clinical site monitor
- Weight less than 125 kg
- Not diabetic (self-reported)
- Unilateral transtibial amputee for more than 1 year
- Currently use a passive prosthetic device without sensors or motors
- Live within 50 miles of UCSD in Southern California
- Have sufficient sensation in the residual limb as tested by clinical site monitor
- Agree to lifestyle requirements: use testing devices only during testing periods, walk at least 14,000 steps per week, and maintain stable diet and activity levels
You will not qualify if you...
- Not currently using a prosthetic device
- Prosthetic device contains active motors or sensors
- Pregnant (due to fall risk)
- Diabetic (self-reported, due to poor limb sensation)
- Under 18 years old
- Over 75 years old
- Poor proprioception or sensation in the residual limb
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
Limber Prosthetics & Orthotics Inc
San Diego, California, United States, 92111
Actively Recruiting
Research Team
D
David Wing, MS
CONTACT
M
Michael Higgins, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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