Recruiting

LIMBER UniLeg

Sponsor:

LIMBER Prosthetics & Orthotics Inc

Code:

NCT06648798

Conditions

Amputation of Lower Limb

Prosthesis

Non-inferiority Trial of Prothesis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Limber Limb

Study Details

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

Study ID

NCT06648798

Start date

Dec 20, 2023

Status verified date

Nov, 2024

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Persons, aged 18 to 75
4. In good general health as determined by clinical site monitor
5. Weight < 125kg
6. Are not diabetic (self reported)
7. Be a unilateral transtibial amputee of more than 1 year since amputation
8. Have an existing prosthetic device(s) that does not use sensors or motors (is passive)
9. Live in the Southern California region (within 50 miles of UCSD)
10. Has sufficient sensation in residual limb as tested by the clinical site monitor
11. 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.)

Exclusion Criteria:

1. Not currently using a prosthetic device
2. Prosthetic device with active motors, sensors, etc.
3. Pregnancy (due to fall risk)
4. Diabetic (due to poor limb sensation), self reported
5. No under 18 (due to inability to consent)
6. No over 75 (due to fall risk)
7. Poor proprioception or sensation at the residual limb

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Intervention

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).

Interventions

Limber Limb

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).

Primary outcome measure

  • Mobility - 6min walk [ Time Frame: Baseline, 4weeks, 8 weeks ]
  • Mobility - Timed-Up-and-Go [ Time Frame: Baseline, 4weeks, 8 weeks ]
  • Mobility--25 foot walk [ Time Frame: All visits (Baseline, 4 weeks, 8 weeks) ]

Central Contacts and Locations

Central contacts

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Falko Kuester, Ph.D

Limber Prosthetics & Orthotics Inc

Recruiting

San Diego, California, United States, 92111

Contacts

Principal Investigator:

Herb Barrack, CPO

More Information

Sponsor

LIMBER Prosthetics & Orthotics Inc

Last update posted

Nov 26, 2024

Last verified

Nov, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LIMBER Prosthetics & Orthotics Inc on 2024-11-26.