Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Orthocare Innovations

Status: Withdrawn

Conditions: Artificial Limbs; Transtibial Amputation

Treatments: Device: Habitual Prosthesis; Device: Energy-Harvesting Mesofluidic Impulse Prosthesis

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04157608

2R44HD080309 (U.S. NIH Grant/Contract)

0309-02

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Habitual Prosthesis

Active Comparator group

Description:

Participant's existing baseline prescribed prosthesis

Treatment:

Device: Habitual Prosthesis

e-MIP

Experimental group

Description:

Experimental ankle-foot prosthesis

Treatment:

Device: Energy-Harvesting Mesofluidic Impulse Prosthesis