NCT06700668

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Apr 2008Jul 2026

Study Start

First participant enrolled

April 17, 2008

Completed
16.6 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2026

Expected
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

17.3 years

First QC Date

November 4, 2024

Last Update Submit

October 10, 2025

Conditions

Transfemoral Amputation

Outcome Measures

Primary Outcomes (1)

  • Metabolic cost

    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 Outcomes (2)

  • Ground reaction force

    An average of 2 sessions in the span of 1 week

  • Gait kinematics

    An average of 2 sessions in the span of 1 week

Study Arms (2)

MIT Powered Knee

EXPERIMENTAL

Subjects wears the MIT powered knee prosthesis.

Device: MIT Powered Knee

Prescribed prosthesis

NO INTERVENTION

Subjects wears their prescribed prosthesis.

Interventions

MIT Powered KneeDEVICE

MIT powered knee prosthesis developed by the MIT Biomechatronics Group.

MIT Powered Knee

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MIT Media Lab

Cambridge, Massachusetts, 02139, United States

Location

Study Officials

  • Hugh Herr, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

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

November 4, 2024

First Posted

November 22, 2024

Study Start

April 17, 2008

Primary Completion

July 17, 2025

Study Completion (Estimated)

July 17, 2026

Last Updated

October 14, 2025

Record last verified: 2025-10

Locations

US(1)