Differences in Physical Performance Measures Among Patients With Unilateral Lower-Limb Amputations Classified as Functional Level K3 Versus K4.
Jaclyn Megan Sions, Emma Haldane Beisheim, Tara Jo Manal...
https://pubmed.ncbi.nlm.nih.gov/29410114Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06648798
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
52 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
Researchers are evaluating the LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, designed to be comparable to traditional passive prosthetic limbs but at a lower cost and faster production time. This trial aims to address the global prosthetic accessibility crisis by using digital technology to provide an affordable and quickly manufactured prosthesis. The study focuses on adults aged 18 to 75 who have undergone unilateral transtibial amputation and typically use passive prosthetic devices without motors or sensors. The study involves one group of 30 participants who will use their usual prosthetic device for one month and then the LIMBER UniLeg for another month. This non-inferiority design compares the new device's performance against the participant's existing passive prosthesis. The LIMBER UniLeg is fully 3D printed as a single piece, aiming to simplify manufacturing and provide a better fit through digital scanning and design. Participants will be assessed at baseline, four weeks, and eight weeks on mobility tests like the 6-minute walk, Timed-Up-and-Go, and 25-foot walk. Quality of care will also be evaluated through gait symmetry, perceived balance confidence, and activity levels measured at home. The study collects both quantitative and qualitative data to compare the functional performance and safety of the LIMBER UniLeg to traditional devices during the two-month study period.
CONDITIONS
Brief Title
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the study duration
- Aged 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 using a passive prosthetic device without motors or sensors
- Living within 50 miles of UCSD in Southern California
- Sufficient sensation in residual limb as tested by clinical site monitor
- Agreement to follow lifestyle considerations: using testing device only during testing periods, walking at least 14,000 steps per week, maintaining similar diet and activity levels throughout study
You will not qualify if you...
- Not currently using a prosthetic device
- Prosthetic device with active motors or sensors
- Pregnancy
- Diabetic (self-reported)
- Under 18 years old
- Over 75 years old
- Poor proprioception or sensation in residual limb
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 2 months
Participants will use their normal prosthetic device for 1 month and then the study device, the LIMBER UniLeg, for 1 month to compare functionality and comfort.
3 visits (baseline, 4 weeks, and 8 weeks) to assess mobility and quality of care
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
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Research Team
D
David Wing, MS
M
Michael Higgins, MS
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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