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

NCT07645729 | Recruiting FDA Device

• 1 other identifier: 2508001761
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

prosthesis; neuroprosthesis; osseointegration; amputation

Outcome Measures

Primary Outcomes (2)

• Kinematic Measures of Lower-Limb Biomechanics

  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

  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

Study Arms (2)

Powered Prosthesis

EXPERIMENTAL

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

Prescribed Prosthesis

ACTIVE COMPARATOR

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

Interventions

Powered Prosthesis DEVICE

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.

Powered Prosthesis

Prescribed Prosthesis DEVICE

Subject's prescribed prosthesis

Prescribed Prosthesis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead

Study Sites (1)

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Researcher

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: June 12, 2026
• Study Start: October 21, 2025
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2031
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)