Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Overview

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.

Full Title of Study: “Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2020

Interventions

  • Device: Habitual Prosthesis
    • Habitual baseline prosthesis prescribed by participant’s clinician.
  • Device: Energy-Harvesting Mesofluidic Impulse Prosthesis
    • e-MIP is an experimental lower limb ankle-foot prosthesis.

Arms, Groups and Cohorts

  • Active Comparator: Habitual Prosthesis
    • Participant’s existing baseline prescribed prosthesis
  • Experimental: e-MIP
    • Experimental ankle-foot prosthesis

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Orthocare Innovations, LLC
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Boone, Chief Executive Officer – Orthocare Innovations, LLC
  • Overall Contact(s)
    • David Boone, PhD, 425-771-0797, dboone@orthocareinnovations.com

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