Recruiting

Powered Ankle

Sponsor:

Massachusetts Institute of Technology

Code:

NCT07645729

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Powered Prosthesis

Prescribed Prosthesis

Study Details

Brief 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.

Conditions

Amputation

Study ID

NCT07645729

Start date

Oct 21, 2025

Status verified date

Jun, 2026

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.).

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Powered Prosthesis

The subject will be provided with a powered ankle prosthesis to attach in place of their customary 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. The subject will be given as much time as necessary to practice using the prosthesis before the experiments begin.

active comparator: Prescribed Prosthesis

The subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care.

Interventions

Powered 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.

Prescribed Prosthesis

Subject's prescribed prosthesis

Primary outcome measure

  • Kinematic Measures of Lower-Limb Biomechanics [ Time Frame: Multiple sessions across 1-2 weeks ]
  • Kinetic Measures of Lower-Limb Biomechanics [ Time Frame: Multiple sessions across 1-2 weeks ]

Central Contacts and Locations

Locations

MIT Media Lab

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Christopher Shallal, B.S.

704-904-6112cshallal@mit.edu

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • prosthesis
  • neuroprosthesis
  • osseointegration
  • amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2026-06-12.