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

June 11, 2026 updated by: Christopher Shallal, Massachusetts Institute of Technology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In summary there will be 3 cohorts in this study, 1) a group of subjects that have an osseointegrated fixture with implanted electrodes, 2) a group that does not have implanted electrodes, and 3) non-amputee healthy control group to serve as a baseline comparison. In summary, the groups will be asked to wear a number of non-invasive sensors and the amputee groups will use a powered ankle prosthesis in place of their customary prosthesis. Data will be collected from various wearable sensors and other motion-capture devices as the subjects walk. At certain points during the study, the control settings of the powered prosthesis will be adjusted, either manually or automatically. Trials will also be conducted with the subjects prescribed prosthesis.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Recruiting
        • MIT Media Lab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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.
Device: Prescribed Prosthesis
Subject's prescribed prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematic Measures of Lower-Limb Biomechanics
Time Frame: Multiple sessions across 1-2 weeks
Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.
Multiple sessions across 1-2 weeks
Kinetic Measures of Lower-Limb Biomechanics
Time Frame: Multiple sessions across 1-2 weeks
Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.
Multiple sessions across 1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2031

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2508001761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data may contain identifying information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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