The purpose of this research is to validate the e-MIP design and function by testing the ability of e-MIP to harvest energy and return a sufficient amount of energy to assist the user during gait. The investigators will also evaluate whether prosthetic users are able to wear and use the e-MIP device long-term.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Habitual baseline prosthesis prescribed by participant's clinician.
e-MIP is an experimental lower limb ankle-foot prosthesis.
Orthocare Innovations, LLC
Edmonds, Washington, United States
Energy returned
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
Time frame: After four weeks with Habitual Prosthesis
Energy returned
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Total Steps
The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Time frame: After four weeks with Habitual Prosthesis
Total Steps
The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Step Rate
The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Time frame: After four weeks with Habitual Prosthesis
Step Rate
The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Step Activity
The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.
Time frame: After four weeks with Habitual Prosthesis
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Step Activity
The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Prosthesis Evaluation Questionnaire
Responses to the psychometrically validated scales of the Prosthesis Evaluation Questionnaire for persons with limb loss, in order to understand the participant's perception of the prosthesis. Questionnaire scores range from 0 to 100. Higher scores indicate a better outcome.
Time frame: After four weeks with Habitual Prosthesis
Prosthesis Evaluation Questionnaire
Responses to the psychometrically validated scales of the Prosthesis Evaluation Questionnaire for persons with limb loss, in order to understand the participant's perception of the prosthesis. Questionnaire scores range from 0 to 100. Higher scores indicate a better outcome.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Spatio-Temporal Gait Parameters
The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.
Time frame: After four weeks with Habitual Prosthesis
Spatio-Temporal Gait Parameters
The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Kinematics during Gait
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
Time frame: After four weeks with Habitual Prosthesis
Kinematics during Gait
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
Time frame: After four weeks with e-MIP (system ON and system OFF)
Kinetics during Gait
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
Time frame: After four weeks with Habitual Prosthesis
Kinetics during Gait
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
Time frame: After four weeks with e-MIP (system ON and system OFF)