Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP

Not Applicable

Withdrawn

• Conditions: Transtibial Amputation; Artificial Limbs
• Interventions: Device: Energy-Harvesting Mesofluidic Impulse Prosthesis; Device: Habitual Prosthesis

• Registration Number: NCT04157608
• Lead Sponsor: Orthocare Innovations, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-02
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Primary Completion: 2022-07-10
• Study Completion: 2022-07-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
e-MIP	Energy-Harvesting Mesofluidic Impulse Prosthesis	Experimental ankle-foot prosthesis
Habitual Prosthesis	Habitual Prosthesis	Participant's existing baseline prescribed prosthesis

Primary Outcome Measures

Name	Time	Method
Energy returned	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 Outcome Measures

Name	Time	Method
Prosthesis Evaluation Questionnaire	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.
Kinematics during Gait	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	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.
Step Rate	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	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.
Spatio-Temporal Gait Parameters	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.
Total Steps	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.

Trial Locations

Locations (1)

Orthocare Innovations, LLC; 🇺🇸 Edmonds, Washington, United States