An interventional study of Habitual Prosthesis and Energy-Harvesting Mesofluidic Impulse Prosthesis in Transtibial Amputation and Artificial Limbs, sponsored by Orthocare Innovations, LLC. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Orthocare Innovations, LLC · Not applicable, Interventional, and Device feasibility
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.
Orthocare Innovations, LLC is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant's existing baseline prescribed prosthesis
Device: Habitual Prosthesis
Experimental ankle-foot prosthesis
Device: Energy-Harvesting Mesofluidic Impulse Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.
e-MIP is an experimental lower limb ankle-foot 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 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
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)
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Orthocare Innovations, LLC