Active Knee Prosthesis Study

Massachusetts Institute of Technology (MIT)

Status: Active, not recruiting

Conditions: Transfemoral Amputation

Treatments: Device: MIT Powered Knee

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06700668

0804002682

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

MIT Powered Knee

Experimental group

Description:

Subjects wears the MIT powered knee prosthesis.

Treatment:

Device: MIT Powered Knee

Prescribed prosthesis

No Intervention group

Description:

Subjects wears their prescribed prosthesis.