Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

NCT04157608 | Withdrawn FDA Device

• 2 other identifiers: 0309-022R44HD080309
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputation; Artificial Limbs

Outcome Measures

Primary Outcomes (2)

• Energy returned

  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

  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 Outcomes (14)

• Total Steps

  After four weeks with Habitual Prosthesis

• Total Steps

  After four weeks with e-MIP (system ON and system OFF)

• Step Rate

  After four weeks with Habitual Prosthesis

• Step Rate

  After four weeks with e-MIP (system ON and system OFF)

• Step Activity

  After four weeks with Habitual Prosthesis

Study Arms (2)

Habitual Prosthesis

ACTIVE COMPARATOR

Participant's existing baseline prescribed prosthesis

Device: Habitual Prosthesis

e-MIP

EXPERIMENTAL

Experimental ankle-foot prosthesis

Device: Energy-Harvesting Mesofluidic Impulse Prosthesis

Interventions

Habitual Prosthesis DEVICE

Habitual baseline prosthesis prescribed by participant's clinician.

Habitual Prosthesis

Energy-Harvesting Mesofluidic Impulse Prosthesis DEVICE

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

e-MIP

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover clinical trial

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 8, 2019
• Study Start: October 2, 2019
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)