Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-02

Study Completion Date

2022-07-10

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.

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Detailed Description

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Conditions

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Transtibial Amputation Artificial Limbs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Crossover clinical trial

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Habitual Prosthesis

Participant's existing baseline prescribed prosthesis

Group Type ACTIVE_COMPARATOR

Habitual Prosthesis

Intervention Type DEVICE

Habitual baseline prosthesis prescribed by participant's clinician.

e-MIP

Experimental ankle-foot prosthesis

Group Type EXPERIMENTAL

Energy-Harvesting Mesofluidic Impulse Prosthesis

Intervention Type DEVICE

e-MIP is an experimental lower limb ankle-foot prosthesis.

Interventions

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Habitual Prosthesis

Habitual baseline prosthesis prescribed by participant's clinician.

Intervention Type DEVICE

Energy-Harvesting Mesofluidic Impulse Prosthesis

e-MIP is an experimental lower limb ankle-foot prosthesis.

Intervention Type DEVICE

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No