Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Transtibial Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04157608
• Other study ID #: 0309-02
• Secondary ID: 2R44HD080309
• Status: Withdrawn
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: July 10, 2022

Study information

• Verified date: October 2023
• Source: Orthocare Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 10, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Artificial Limbs
• Transtibial Amputation

Intervention

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

Locations

Country	Name	City	State
United States	Orthocare Innovations, LLC	Edmonds	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Orthocare Innovations, LLC	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Total Steps	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
Secondary	Total Steps	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)
Secondary	Step Rate	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
Secondary	Step Rate	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)
Secondary	Step Activity	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
Secondary	Step Activity	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)
Secondary	Prosthesis Evaluation Questionnaire	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
Secondary	Prosthesis Evaluation Questionnaire	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)
Secondary	Spatio-Temporal Gait Parameters	The spatio-temporal parameters of gait, such as walking speed, will be measured using motion analysis.	After four weeks with Habitual Prosthesis
Secondary	Spatio-Temporal Gait Parameters	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)
Secondary	Kinematics during Gait	Kinematics such as hip, knee, and ankle joint angles will be measured using motion analysis.	After four weeks with Habitual Prosthesis
Secondary	Kinematics during Gait	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)
Secondary	Kinetics during Gait	Kinetics such as hip, knee, and ankle joint torques will be measured using motion analysis.	After four weeks with Habitual Prosthesis
Secondary	Kinetics during Gait	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)