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).
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
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
Single group
Limber Limb
DeviceParticipants will be 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).
Mobility - 6min walk
Measure total distance for a timed six-min walk test for both the Limber UniLeg vs. existing prosthetic devices.
Mobility - Timed-Up-and-Go
Measure time for the timed up and go (TUG) test for both the Limber UniLeg vs. existing prosthetic devices.
Mobility--25 foot walk
Time to cover 25 feet walking at a normal speed
Quality of Care - Gait Symmetry
Measure load distribution and stride length using a six-foot force pad test for both the UniLeg and existing prosthetic device to quantify gait symmetry.
Quality of Care - Perceived Balance Confidence_Limits of Stability
Assess Participant's Limit of Stability using the NeuroCom Balance Manager. Metrics include movement velocity, directional control, and maximal excursion in 8 directions (cardinal and semi-cardinal). Higher scores are better and indicative of both a wider cone of stability (associated with less fall risk) and balance confidence (associated with greater overall movement and less fall rsik)
Quality of Care - Perceived Balance Confidence_Adaptation Test
Assess Participant's Adaptation using the NeuroCom Balance Manager. Metrics include recovery time following a pertubation. Unit of measurement is milliseconds with higher scores being indicative of slower recovery (associated with higher fall risk). Across 5 trials participants are expected to improve. The degree of improvement (Score 1-Score 5) is also a metric of interest with higher scores associated with less fall risk.
Quality of Care - Perceived Balance Confidence_Motor Control
Assess Participant's Motor Control using the NeuroCom Balance Manager. Metrics include stability following a pertubation. Unit of measurement is milliseconds with higher scores being indicative of slower recovery (associated with higher fall risk). Scores are averaged across multiple moderate and large pertubations in both the forward and backward directions.
Clinical Outcome - Pain
Collect Numeric Pain Rating Scale (NPRS) measures for the UniLeg and existing prosthetic device to characterize the reduction in joint, lower back, and limb pain. The scale is completed on a visual slider and then measured by location to be between 1-100 with higher numbers being indicative of less pain/greater comfort.
Clinical Outcome - Quality of Life-European Quality of Life 5-Dimension 5-Level questionnaire
Collect the European Quality of Life 5-Dimension 5-Level questionnaire (EQ5D5L) measures for the UniLeg and existing prosthetic device to characterize the improvements in health-related quality of life. The questionnaire is self-completed to assess five dimensions of health: Mobility, Self-care, Usual activities, Pain and discomfort, and Anxiety and depression on a 5 point scale from 1 (none) to 5 (extreme) with 5 being positive on mobility, self-care and usual activities and 1 on pain and anxiety subscales.
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LIMBER Prosthetics & Orthotics Inc
Lead sponsor
University of California, San Diego
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
