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

NCT06648798 | Recruiting FDA Device

• 2 other identifiers: 8036321R43HD112285-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Amputation of Lower Limb; Prosthesis; Non-inferiority Trial of Prothesis

Keywords

Prosthesis; Trans-tibial amputation; Limber Unileg; 3D Printed

Outcome Measures

Primary Outcomes (3)

• Mobility - 6min walk

  Measure total distance for a timed six-min walk test for both the Limber UniLeg vs. existing prosthetic devices.

  Baseline, 4weeks, 8 weeks

• Mobility - Timed-Up-and-Go

  Measure time for the timed up and go (TUG) test for both the Limber UniLeg vs. existing prosthetic devices.

  Baseline, 4weeks, 8 weeks

• Mobility--25 foot walk

  Time to cover 25 feet walking at a normal speed

  All visits (Baseline, 4 weeks, 8 weeks)

Secondary Outcomes (6)

• Quality of Care - Gait Symmetry

  Baseline, 4weeks, 8 weeks

• Quality of Care - Perceived Balance Confidence_Limits of Stability

  Baseline, 4weeks, 8 weeks

• Quality of Care - Perceived Balance Confidence_Adaptation Test

  Baseline, 4weeks, 8 weeks

• Quality of Care - Perceived Balance Confidence_Motor Control

  Baseline, 4weeks, 8 weeks

• Quality of Care - Utilization--At-home movement

  Baseline-4weeks, 4weeks-8weeks

Other Outcomes (2)

• Clinical Outcome - Pain

  Baseline, 4weeks, 8 weeks

• Clinical Outcome - Quality of Life-European Quality of Life 5-Dimension 5-Level questionnaire

  Baseline, 4weeks, 8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Participants 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).

Device: Limber Limb

Interventions

Limber Limb DEVICE

Participants 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).

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Weight \< 125kg
• Are not diabetic (self reported)
• Be a unilateral transtibial amputee of more than 1 year since amputation
• Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
• Live in the Southern California region (within 50 miles of UCSD)
• Has sufficient sensation in residual limb as tested by the clinical site monitor
• 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.)

You may not qualify if:

• 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
• No under 18 (due to inability to consent)
• No over 75 (due to fall risk)
• Poor proprioception or sensation at the residual limb

Sponsors & Collaborators

• LIMBER Prosthetics & Orthotics Inc: lead
• University of California, San Diego: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of California San Diego

La Jolla, California, 92093, United States

RECRUITING

Limber Prosthetics & Orthotics Inc

San Diego, California, 92111, United States

RECRUITING

Related Publications (20)

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Related Links

• Limber Prosthetics Website

Study Officials

• Herb Barrack, CPO

  LIMBER Prosthetics & Orthotics Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Wing, MS

CONTACT

8585349315; dwing@health.ucsd.edu

Michael Higgins, MS

CONTACT

8585349315; mdhiggins@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 18, 2024
• Study Start: December 20, 2023
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)