Recruiting

Bionic Prosthesis

Sponsor:

Massachusetts Institute of Technology

Code:

NCT07204912

Conditions

Transfemoral Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

MIT Powered Leg

Study Details

Brief summary:

The purpose of this study is to evaluate the performance and adaptability of a neural-controlled powered knee or ankle prosthesis across diverse real-world mobility tasks. This research aims to assess how compare the sense of embodiment with the device, symmetry, and stability of a person with an lower-extremity amputation walking with a bionic prosthesis and their prescribed prosthesis. Findings from this study will inform future developments in bionic prosthesis design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.

Conditions

Transfemoral Amputation

Study ID

NCT07204912

Start date

May 31, 2025

Status verified date

Sep, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or Female age 18-70.
  • The patient must have a unilateral transfemoral 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

Basic Science

Interventions and Outcome Measures

Arms

experimental: MIT Powered Leg

Subjects wears the MIT powered knee-ankle prosthesis.

no intervention: Prescribed prosthesis

Subjects wears their prescribed prosthesis.

Interventions

MIT Powered Leg

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Primary outcome measure

  • Kinematic and Kinetic Measures of Lower-Limb Biomechanics [ Time Frame: An average of 2 sessions in the span of 1 week ]
  • Spatiotemporal Gait Parameters [ Time Frame: An average of 2 sessions in the span of 1 week ]
  • Assessment of Patient Ability to Control each Joint of the Prosthesis [ Time Frame: An average of 2 sessions in the span of 1 week ]

Central Contacts and Locations

Central contacts

John A McCullough, B.S. Mechanical Engineering

424-603-1074johnmccu@mit.edu

Locations

MIT Media Lab

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

John A McCullough, B.S. Mechanical Engineering

424-603-1074johnmccu@mit.edu

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Keywords

  • Transfemoral Amputation
  • Bionic Prosthesis
  • Knee Prosthesis

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 2025-10-02.