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

Who can join

Ages 18 to 70 · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* 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 Criteria:

* 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.).

About the study

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.

What is being tested

• Powered Prosthesis (device)
• Prescribed Prosthesis (device)

Sponsor: Massachusetts Institute of Technology · Participants: 10 · Started: Oct 21, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07645729

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.