Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users

Conditions
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Transtibial Amputation, Artificial Limbs

Intervention / Treatment
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* Device: Habitual Prosthesis
* Device: Energy-Harvesting Mesofluidic Impulse Prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral transtibial amputation At least twelve months post-amputation Currently walking on a prosthesis for at least one year Uses modular endoskeletal prosthetic components Has bilateral normal range of motion Ability to walk independently and for an extended length of time (walking ability of each individual will be assessed by the principal investigator or study prosthetist during the recruitment period) Ability to communicate individual perceptions Ability to provide informed consent Exclusion Criteria: Confounding injury or musculoskeletal problem Pregnancy Lower limb peripheral neuropathy Symptomatic cardiovascular disease or chronic obstructive pulmonary disease Not able to read and understand English

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Habitual Prosthesis<br>Participant's existing baseline prescribed prosthesis | Device: Habitual Prosthesis<br>* Habitual baseline prosthesis prescribed by participant's clinician.<br>|
| Experimental: e-MIP<br>Experimental ankle-foot prosthesis | Device: Energy-Harvesting Mesofluidic Impulse Prosthesis<br>* e-MIP is an experimental lower limb ankle-foot prosthesis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Energy returned | The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time. | 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. | After four weeks with e-MIP (system ON and system OFF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Steps | The number of steps taken by the participant will be recorded over four weeks with a step activity monitor. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After four weeks with Habitual Prosthesis | 
| Kinematics during Gait | Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis. | 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. | After four weeks with Habitual Prosthesis | 
| Kinetics during Gait | Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis. | After four weeks with e-MIP (system ON and system OFF) |