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

NCT07204912 | Recruiting DMC FDA Device

• 1 other identifier: 2503001589
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Transfemoral Amputation; Bionic Prosthesis; Knee Prosthesis

Outcome Measures

Primary Outcomes (3)

• Kinematic and Kinetic Measures of Lower-Limb Biomechanics

  Quantitative analysis of lower-limb biomechanics, including joint angles, ground reaction forces, joint torques, and mechanical power during level-ground walking, stair negotiation, and other functional tasks. Outcomes will be assessed using a motion capture system (e.g., Vicon), instrumented force plates, and embedded prosthesis sensors to evaluate gait symmetry, stability, and mechanical efficiency.

  An average of 2 sessions in the span of 1 week

• Spatiotemporal Gait Parameters

  Evaluation of spatiotemporal gait parameters during ambulation with the powered prosthesis. Specific measures include stride length, cadence, walking speed, and stance-to-swing ratio. Parameters will be obtained using a motion capture system (e.g., Vicon) and an instrumented walkway. Data will be analyzed to assess functional walking ability and compared to normative or baseline values

  An average of 2 sessions in the span of 1 week

• Assessment of Patient Ability to Control each Joint of the Prosthesis

  Assessment of volitional control of the powered knee and ankle joints via neural signals from the residual limb. Participants will perform isolated joint control trials in seated positions. Outcomes include joint command accuracy, latency, and repeatability, evaluated using surface electromyography (EMG) and motion capture. These measures will quantify the participant's ability to intentionally control each prosthetic joint.

  An average of 2 sessions in the span of 1 week

Study Arms (2)

MIT Powered Leg

EXPERIMENTAL

Subjects wears the MIT powered knee-ankle prosthesis.

Device: MIT Powered Leg

Prescribed prosthesis

NO INTERVENTION

Subjects wears their prescribed prosthesis.

Interventions

MIT Powered Leg DEVICE

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

MIT Powered Leg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 Officials

• Hugh Herr

  MIT Media Lab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John A McCullough, B.S. Mechanical Engineering

CONTACT

424-603-1074; johnmccu@mit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: October 2, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)