Assist-Knee: Energy-Harvesting Knee Prosthesis

Overview

The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy and return energy .

Full Title of Study: “Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Device Feasibility
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 26, 2020

Interventions

  • Device: Assist-Knee
    • Assist-Knee is an experimental lower limb knee prosthesis.
  • Device: Habitual Prosthesis
    • Habitual baseline prosthesis prescribed by participant’s clinician.

Arms, Groups and Cohorts

  • Active Comparator: Habitual Prosthesis
    • Participant’s prescribed prosthesis
  • Experimental: Assist-Knee
    • Experimental knee prosthesis

Clinical Trial Outcome Measures

Primary Measures

  • Time to Complete Sit-to-Stand
    • Time Frame: Collection at baseline
    • The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition.
  • Time to Complete Sit-to-Stand
    • Time Frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
    • The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition.
  • Symmetry of Knee Joint Moment
    • Time Frame: Collection at baseline
    • Ratio of knee joint moment between left and right sides.
  • Symmetry of Knee Joint Moment
    • Time Frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
    • Ratio of knee joint moment between left and right sides.
  • Survey Responses
    • Time Frame: Collection at baseline
    • Participant responses to a custom survey documenting subject’s perception of: Assist-Knee’s performance, subject preference, feeling of safety, weight, feeling of assistance, and overall opinion of the system. The survey will also include the relevant transfer question from the psychometrically validated Prosthesis Evaluation Questionnaire (PEQ) for persons with limb loss.
  • Survey Responses
    • Time Frame: Within 30 minutes after using each Assist-Knee condition
    • Participant responses to a custom survey documenting subject’s perception of: Assist-Knee’s performance, subject preference, feeling of safety, weight, feeling of assistance, and overall opinion of the system. The survey will also include the relevant transfer question from the psychometrically validated Prosthesis Evaluation Questionnaire (PEQ) for persons with limb loss.
  • Timed Up and Go (TUG) Test
    • Time Frame: Collection at baseline
    • The Timed Up and Go (TUG) test is a timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down.
  • Timed Up and Go (TUG) Test
    • Time Frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
    • The Timed Up and Go (TUG) test is a timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down.

Secondary Measures

  • Time to Complete Stand-to-Sit
    • Time Frame: Collection at baseline
    • The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition.
  • Time to Complete Stand-to-Sit
    • Time Frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
    • The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition.
  • Weight Distribution
    • Time Frame: Collection at baseline
    • Ratio of ground reaction forces between left and right sides for both stand-to-sit and sit-to-stand transitions.
  • Weight Distribution
    • Time Frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
    • Ratio of ground reaction forces between left and right sides for both stand-to-sit and sit-to-stand transitions.
  • Symmetry of Kinematics
    • Time Frame: Collection at baseline
    • Comparison of lower limb joint angles between right and left sides.
  • Symmetry of Kinematics
    • Time Frame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
    • Comparison of lower limb joint angles between right and left sides.

Participating in This Clinical Trial

Inclusion Criteria

  • Unilateral transfemoral limb loss
  • At least one year post-amputation and currently successfully using a prosthesis
  • Uses modular endoskeletal prosthetic components
  • Has bilateral normal range of motion
  • Ability to perform the following activities:
  • Walking ability or ability to take steps over 10 meters
  • Upright standing stability
  • Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
  • Sit-to-stand stability (i.e. rise from a seated position independently)
  • Ability to communicate individual perceptions in the English language
  • 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
  • Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Orthocare Innovations, LLC
  • Collaborator
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sarah Chang, Director of Research & Development – Orthocare Innovations, LLC
  • Overall Official(s)
    • Sarah Chang, PhD, Principal Investigator, Orthocare Innovations, LLC

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