Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Habitual Prosthesis Participant's existing baseline prescribed prosthesis |
Device: Habitual Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.
|
| Experimental: e-MIP Experimental ankle-foot prosthesis |
Device: Energy-Harvesting Mesofluidic Impulse Prosthesis
e-MIP is an experimental lower limb ankle-foot prosthesis.
|
Outcome Measures
Primary Outcome Measures
- Energy returned [After four weeks with Habitual Prosthesis]
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
- Energy returned [After four weeks with e-MIP (system ON and system OFF)]
The amount of energy returned at the ankle joint, calculated from ankle torque and angle sensors with respect to time.
Secondary Outcome Measures
- Total Steps [After four weeks with Habitual Prosthesis]
The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.
- Total Steps [After four weeks with e-MIP (system ON and system OFF)]
The number of steps taken by the participant will be recorded over four weeks with a step activity monitor.
- Step Rate [After four weeks with Habitual Prosthesis]
The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.
- Step Rate [After four weeks with e-MIP (system ON and system OFF)]
The speed of steps taken by the participant will be recorded over four weeks with a step activity monitor.
- Step Activity [After four weeks with Habitual Prosthesis]
The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.
- Step Activity [After four weeks with e-MIP (system ON and system OFF)]
The number of continuous steps taken by the participant will be recorded over four weeks with a step activity monitor.
- Prosthesis Evaluation Questionnaire [After four weeks with Habitual Prosthesis]
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.
- Prosthesis Evaluation Questionnaire [After four weeks with e-MIP (system ON and system OFF)]
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.
- Spatio-Temporal Gait Parameters [After four weeks with Habitual Prosthesis]
The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.
- Spatio-Temporal Gait Parameters [After four weeks with e-MIP (system ON and system OFF)]
The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.
- Kinematics during Gait [After four weeks with Habitual Prosthesis]
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
- Kinematics during Gait [After four weeks with e-MIP (system ON and system OFF)]
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
- Kinetics during Gait [After four weeks with Habitual Prosthesis]
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
- Kinetics during Gait [After four weeks with e-MIP (system ON and system OFF)]
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Unilateral transtibial amputation
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At least twelve months post-amputation
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Currently walking on a prosthesis for at least one year
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Uses modular endoskeletal prosthetic components
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Has bilateral normal range of motion
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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)
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Ability to communicate individual perceptions
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Ability to provide informed consent
Exclusion Criteria:
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Confounding injury or musculoskeletal problem
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Pregnancy
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Lower limb peripheral neuropathy
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Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
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Not able to read and understand English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orthocare Innovations, LLC | Edmonds | Washington | United States | 98020 |
Sponsors and Collaborators
- Orthocare Innovations, LLC
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0309-02
- 2R44HD080309