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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44HD080309 | U.S. NIH Grant/Contract | View source |
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Investigational device under development
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habitual Prosthesis | Active Comparator | Participant's existing baseline prescribed prosthesis |
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| e-MIP | Experimental | Experimental ankle-foot prosthesis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Habitual Prosthesis | Device | Habitual baseline prosthesis prescribed by participant's clinician. |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthocare Innovations, LLC | Edmonds | Washington | 98020 | United States |
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Crossover clinical trial
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| Energy-Harvesting Mesofluidic Impulse Prosthesis | Device | e-MIP is an experimental lower limb ankle-foot prosthesis. |
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| 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) |