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

M

Massachusetts Institute of Technology (MIT)

Status

Enrolling

Conditions

Transfemoral Amputation

Treatments

Device: MIT Powered Leg

Study type

Interventional

Funder types

Other

Identifiers

NCT07204912
2503001589

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.).

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 2 patient groups

MIT Powered Leg
Experimental group
Description:
Subjects wears the MIT powered knee-ankle prosthesis.
Treatment:
Device: MIT Powered Leg
Prescribed prosthesis
No Intervention group
Description:
Subjects wears their prescribed prosthesis.

Trial contacts and locations

1

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Central trial contact

John A McCullough, B.S. Mechanical Engineering

Data sourced from clinicaltrials.gov

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