RecruitingNot ApplicableNCT07645729

Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks


Sponsor

Massachusetts Institute of Technology

Enrollment

10 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria2

  • Male or Female age 18-70. The patient must have a unilateral transtibial amputation . The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).
  • The patient must have adequate socket to support the device.

Exclusion Criteria1

  • Women who are pregnant. Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPowered Prosthesis

This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking.

DEVICEPrescribed Prosthesis

Subject's prescribed prosthesis


Locations(1)

MIT Media Lab

Cambridge, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07645729


Related Trials