Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

October 6, 2023 updated by: Orthocare Innovations, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Washington
      • Edmonds, Washington, United States, 98020
        • Orthocare Innovations, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Energy returned
Time Frame: 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.
After four weeks with Habitual Prosthesis
Energy returned
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Steps
Time Frame: 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.
After four weeks with Habitual Prosthesis
Total Steps
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)
Step Rate
Time Frame: 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.
After four weeks with Habitual Prosthesis
Step Rate
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)
Step Activity
Time Frame: 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.
After four weeks with Habitual Prosthesis
Step Activity
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)
Prosthesis Evaluation Questionnaire
Time Frame: 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.
After four weeks with Habitual Prosthesis
Prosthesis Evaluation Questionnaire
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)
Spatio-Temporal Gait Parameters
Time Frame: After four weeks with Habitual Prosthesis
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
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)
Kinematics during Gait
Time Frame: After four weeks with Habitual Prosthesis
Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.
After four weeks with Habitual Prosthesis
Kinematics during Gait
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)
Kinetics during Gait
Time Frame: After four weeks with Habitual Prosthesis
Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.
After four weeks with Habitual Prosthesis
Kinetics during Gait
Time Frame: 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.
After four weeks with e-MIP (system ON and system OFF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orthocare Innovations, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0309-02
  • 2R44HD080309 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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