The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is:
* Does motorized prosthesis improve ambulation speed, balance, control, or efficiency when performing everyday activities? * What problems arise when using a motorized prosthesis? Researchers will compare mobility of the participants when using and not using the motorized prosthesis to see if mobility and/or function improves.
Participants will perform various activities with and without the motorized prosthesis including:
* Walking at a mild incline/decline (0°-15°) on treadmill or over-ground * Ascending or descending stairs * Stand to sit and sit to stand transitions * All terrain walking over ground * Turning * Any combination of the above-mentioned activities
Individuals age 18 to 85 with or without lower-limb amputation
Able to understand and follow simple directions in English based on ability to provide verbal consent
Able to walk at least 30 feet with or without a walking aid
Able to safely fit into a device configuration and tolerate assistance
Any neurological, musculoskeletal (other than lower-limb amputation) or cardiorespiratory injury, health condition (including pregnancy), or diagnosis that would affect the ability to walk as directed for short periods of time.
Participant or caregiver report that the perspective participant's physician has recommended that they not engage in moderate intensity walking exercise.
Subject mass greater than the engineered limit of the device (90 kg or 198 lbs) Note: No exclusions will be made on the basis of race, gender or ethnic background.
Single group
Passive prosthesis
DeviceThe participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.
Motorized prosthesis
DeviceThe motorized prosthesis is an experimental device. The device is constructed from plastic and metal. It has motors, sensors, and electronic systems to control the prosthesis to mimic the behavior of a biological joint. The device is determined non-significant risk by the sponsor's Institutional Review Board.
Joint position
Motion capture measurements will be taken to calculate joint position (degrees) of the ankle, knee, hip, and torso. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Joint Velocity
Motion capture will be used to record joint velocity (deg/s) of the ankle, knee, hip, and torso. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Ground reaction force
The force a participant exerts on the ground (Newtons) will be measured using a force plate. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Muscle Electric Potential
Muscle electric potential will be measured using skin mounted electrodes (surface electromyography) and reported in volts. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
User Perception
User perception of the device will be assessed using NASA TLX survey. Participants will assess the device on a scale of 1-10 based on a questionnaire. Participant measurements will be averaged per condition to generate a participant average. Participant averages will be pooled to determine an average per condition.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
