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NCT Number: NCT06700668

Active Knee Prosthesis Study

The purpose of the study is to investigate the clinical and functional outcomes of a powered knee prosthesis for people with a transfemoral amputation in the domain of gait, free space control, and embodiment

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Transfemoral Amputation

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or Female age 22-65.
  • 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 Knee

Device

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

Primary outcomes

  1. Metabolic cost

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

    Effort of participants' walking measured via metabolic cost, which is measured using an mask that measures the Oxygen and Carbon dioxide levels.

Secondary outcomes

  1. Ground reaction force

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

    Ground reaction forces will be measured via force plates on the ground.

  2. Gait kinematics

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

    Motion capture data will be collected using a validated system (e.g., Vicon, or similar motion capture software). Reflective markers will be placed on anatomical landmarks following a standard gait model. Kinematic measures, including joint angles (hip, knee, and ankle), step length, stride length, cadence, and walking speed, will be derived.

Sponsors and collaborators

Lead sponsor

Massachusetts Institute of Technology

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Important dates

Study start
2008
Primary completion
2025
Study completion
2026
First posted
Nov 22, 2024
Registry last updated
Oct 14, 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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