Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks

Massachusetts Institute of Technology10 enrolled

Overview

The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.

In summary there will be 3 cohorts in this study, 1) a group of subjects that have an osseointegrated fixture with implanted electrodes, 2) a group that does not have implanted electrodes, and 3) non-amputee healthy control group to serve as a baseline comparison. In summary, the groups will be asked to wear a number of non-invasive sensors and the amputee groups will use a powered ankle prosthesis in place of their customary prosthesis. Data will be collected from various wearable sensors and other motion-capture devices as the subjects walk. At certain points during the study, the control settings of the powered prosthesis will be adjusted, either manually or automatically. Trials will also be conducted with the subjects prescribed prosthesis.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Amputation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or Female age 18-70. The patient must have a unilateral transtibial 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.).

Outcomes

Primary Outcomes

Kinematic Measures of Lower-Limb Biomechanics

Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.

Time frame: Multiple sessions across 1-2 weeks

Kinetic Measures of Lower-Limb Biomechanics

Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.