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Introducing the LIMBER UniLeg
The LIMBER UniLeg is a highly personalized, fully 3D printed below-knee prosthetic limb. A dynamic, water-resistant, prosthesis tailored specifically for your comfort and mobility.
The process begins with a smartphone scan which is used to generate a highly detailed digital model of the residual limb. This model is then translated into a fully personalized prosthesis designed specifically for the individual.
Study Inclusion Criteria
Participation in this study is open to individuals aged 18 to 65 with a below-the-knee amputation, currently fitted with a passive lower limb prosthesis without sensors or motors, and located in San Diego and the Southern California region. Potential risks include but are not limited to: acute trauma to the residual limb including skin breakdown, abrasion, and bruising.
Expanding Our Reach
We have been working to advance our core mission of aiding amputees with our longest-standing user having worn the device for over 15 months. We have also fitted five legs in Ukraine and 31 legs in Mexico, with two successful pediatric cases in San Diego.
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Apply to the
Limber UniLeg Study
The Study process
There will be up to four in person visits which may take up to 4 hours and require up to 2 hours of light physical activity.
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Review your medical history, physical exam and vital signs.
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3D scanning of the residual limb and sound leg.
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Physical activity assessments with current prosthesis and answered questionnaires.
Screening Visit
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Fitting the LIMBER UniLeg
Visit 2
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Repeat the assessment with the UniLeg instead of the conventional prosthesis.
Visit 3
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Repeat the assessment once more after wearing the UniLeg for one month.
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Return the LIMBER UniLeg.
Visit 4
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Weekly phone calls between Visit 2, 3, and 4 to ensure the prosthetic device is functioning properly and address any questions or concerns you may have.
Follow up phone calls
The purpose of this study is to compare the mobility and quality of care of the LIMBER UniLeg as compared to existing traditional prosthetic devices.
This form explains the research so that you may make an informed decision about participating.
• Research is voluntary - whether or not you participate is your decision. You can discuss your decision with others (such as family, friends or another physician).
• We kindly request that if you agree at one point and then change your mind, please do so before the first session.
• If you say no, we will not hold your decision against you.
• You can say no even if the person inviting you is part of your healthcare team.
• Your decision will not affect your health care insurance or other benefits you may be entitled to.
• Please ask the study coordinator, doctor or study team questions about anything that is not clear, and feel free to ask questions and mention concerns before, during, and after the research.
• You will be given a copy of this consent form and the Participant’s Bill of Rights.
Lower-limb prosthetic devices currently available on the market are expensive and require multiple trips to prosthetic clinics where on-site prosthetists manually sculpt, fit, and align the device. Depending on the clinic, patients may wait weeks to be fit with a test socket and then wait again before a definitive prosthesis is ready. Due to the manual nature of socket fabrication, assembly, and alignment, results will vary from clinic to clinic with no reliable way to ensure that a particular device will be comfortable. These problems lead to wasted time, excessive trips back and forth for amputees with limited mobility, frustration, poor comfort, and increased cost.
The LIMBER UniLeg offers a solution that provides reliable comfort. A diagnostic test socket may not be required, so fewer visits to the clinic are necessary in most cases. 3D scanning is used during the initial visit, which serves to shorten the time patients spend at the clinic, and helps get them on their feet sooner. The LIMBER UniLeg weighs less than conventional prosthetic devices, which results in improved comfort and reduced energy spent during walking.
The LIMBER UniLeg is a personalized, single-piece (unibody) 3D printed, transtibial prosthetic limb. A smartphone generated 3D model is used to create an entire prosthesis in a single piece while retaining multi-axial dynamic gait performance. This study will help investigate the function, efficacy, and quality of care of the LIMBER UniLeg as compared to traditional passive prosthetic devices.
Why is this study being done?
If you agree to be in this study, you will be asked to perform the following to the best of your ability:
• Use the UniLeg only during the controlled testing periods.
• Walk at least 14,000 steps per week (average of 1 mile per day).
• Maintain a similar diet and activity level throughout study duration (no abrupt changes of weight, activity, medications, etc.)
The study will consist of three in person visits and 3-6 phone calls. Each visit will last approximately 4 hours. All visits will be conducted at the Exercise and Physical Activity Resource Center (EPARC) at UC San Diego. All procedures listed below are considered experimental and will be billed to the research study. The total duration of your involvement in the study is approximately 2 months.
What will I be asked to do in this study and which procedures are standard of care and which are experimental?
Dr. Falko Kuester (IRB #803632) and associates are conducting a research study to find out more about the UniLeg prosthetic limb in unilateral transtibial (below-the-knee) amputees with existing prosthetic devices. You have been asked to participate in this study because you are currently using a passive lower limb prosthetic device that does not use sensors or motors. This is a single site study and there will be approximately 30 participants at this site. This study is funded by the UC San Diego Altman Clinical and Translational Research Institute in conjunction with the CHEI Lab at the UCSD Qualcomm Institute.
Drs. Pelz and De Vivo, who are also members of the research team, will not be involved in the recruitment or selection of study participants and/or the informed consent process, as they have financial relationships with Limber Prosthetics and Orthotics, Inc., the device manufacturer.