Active Knee Prosthesis Study

October 10, 2025 updated by: Massachusetts Institute of Technology
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • MIT Media Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIT Powered Knee
Subjects wears the MIT powered knee prosthesis.
Device: MIT Powered Knee
MIT powered knee prosthesis developed by the MIT Biomechatronics Group.
No Intervention: Prescribed prosthesis
Subjects wears their prescribed prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of 2 sessions in the span of 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of 2 sessions in the span of 1 week
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.
An average of 2 sessions in the span of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Institute of Technology

Collaborators

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Hugh Herr, PhD, Massachusetts Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2008

Primary Completion (Actual)

July 17, 2025

Study Completion (Estimated)

July 17, 2026

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 0804002682

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Subject confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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