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NCT Number: NCT07204912

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

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.

Recruiting

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Key information

Conditions

Transfemoral Amputation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

Location status: Recruiting

Location contact

John A McCullough, B.S. Mechanical Engineering

CONTACT

[email protected]

424-603-1074

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

MIT Powered Leg

Device

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Primary outcomes

  1. Kinematic and Kinetic Measures of Lower-Limb Biomechanics

    Time frame: An average of 2 sessions in the span of 1 week

    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.

  2. Spatiotemporal Gait Parameters

    Time frame: An average of 2 sessions in the span of 1 week

    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

  3. Assessment of Patient Ability to Control each Joint of the Prosthesis

    Time frame: An average of 2 sessions in the span of 1 week

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

John A McCullough, B.S. Mechanical Engineering

CONTACT

[email protected]

424-603-1074

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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