Clinical trial NCT04157608: Energy-Harvesting Mesofluidic Impulse Prosthesis: e-MIP
Official title: Evaluation of an Energy-Harvesting Mesofluidic Impulse Prosthesis (e-MIP) in Transtibial Prosthesis Users
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Transtibial Amputation
Artificial Limbs
Lead sponsor: Orthocare Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover clinical trial
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Energy returned
timeFrame: After four weeks with Habitual Prosthesis
measure: Energy returned
timeFrame: After four weeks with e-MIP (system ON and system OFF)
Secondary outcomes:
measure: Total Steps
timeFrame: After four weeks with Habitual Prosthesis
measure: Total Steps
timeFrame: After four weeks with e-MIP (system ON and system OFF)
measure: Step Rate
timeFrame: After four weeks with Habitual Prosthesis
measure: Step Rate
timeFrame: After four weeks with e-MIP (system ON and system OFF)
measure: Step Activity
timeFrame: After four weeks with Habitual Prosthesis
measure: Step Activity
timeFrame: After four weeks with e-MIP (system ON and system OFF)
measure: Prosthesis Evaluation Questionnaire
timeFrame: After four weeks with Habitual Prosthesis
measure: Prosthesis Evaluation Questionnaire
timeFrame: After four weeks with e-MIP (system ON and system OFF)
measure: Spatio-Temporal Gait Parameters
timeFrame: After four weeks with Habitual Prosthesis
measure: Spatio-Temporal Gait Parameters
timeFrame: After four weeks with e-MIP (system ON and system OFF)
measure: Kinematics during Gait
timeFrame: After four weeks with Habitual Prosthesis
measure: Kinematics during Gait
timeFrame: After four weeks with e-MIP (system ON and system OFF)
measure: Kinetics during Gait
timeFrame: After four weeks with Habitual Prosthesis
measure: Kinetics during Gait
timeFrame: After four weeks with e-MIP (system ON and system OFF)
Other outcomes:
Locations:
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
References: