Evaluation of a Neural-Controlled Powered Prosthesis Across Diverse Real-World Tasks

NCT ID: NCT07204912

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2028-05-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

MIT Powered Leg

Subjects wears the MIT powered knee-ankle prosthesis.

Group Type: EXPERIMENTAL

MIT Powered Leg

Intervention Type: DEVICE

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Prescribed prosthesis

Subjects wears their prescribed prosthesis.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MIT Powered Leg

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Intervention Type: DEVICE

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugh Herr

Role: PRINCIPAL_INVESTIGATOR

MIT Media Lab

Locations

MIT Media Lab

Cambridge, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John A McCullough, B.S. Mechanical Engineering

Role: CONTACT

johnmccu@mit.edu

424-603-1074

Facility Contacts

John A McCullough, B.S. Mechanical Engineering

Role: primary

johnmccu@mit.edu

424-603-1074

Other Identifiers

2503001589

Identifier Type: -

Identifier Source: org_study_id