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出境医 / 临床实验 / Assist-Knee: Energy-Harvesting Knee Prosthesis

Assist-Knee: Energy-Harvesting Knee Prosthesis

Study Description
Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Transfemoral Amputation Artificial Limbs Device: Assist-Knee Device: Habitual Prosthesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover clinical trial
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users
Actual Study Start Date : July 15, 2019
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : February 26, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Habitual Prosthesis
Participant's prescribed prosthesis
 Device: Habitual Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.
Experimental: Assist-Knee
Experimental knee prosthesis
 Device: Assist-Knee
Assist-Knee is an experimental lower limb knee prosthesis.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Symmetry of Knee Joint Moment [ Time Frame: Collection at baseline ]
    Ratio of knee joint moment between left and right sides.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Symmetry of Kinematics [ Time Frame: Collection at baseline ]
    Comparison of lower limb joint angles between right and left sides.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Locations
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United States, Washington
Orthocare Innovations, LLC
Edmonds, Washington, United States, 98020
Sponsors and Collaborators
Orthocare Innovations, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Sarah Chang, PhD Orthocare Innovations, LLC
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 17, 2019
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE July 15, 2019
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assist-Knee: Energy-Harvesting Knee Prosthesis
Official Title  ICMJE Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users
Brief Summary 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 .
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover clinical trial
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Transfemoral Amputation
  • Artificial Limbs
Intervention  ICMJE
  • Device: Assist-Knee
    Assist-Knee is an experimental lower limb knee prosthesis.
  • Device: Habitual Prosthesis
    Habitual baseline prosthesis prescribed by participant's clinician.
Study Arms  ICMJE
  • Active Comparator: Habitual Prosthesis
    Participant's prescribed prosthesis
    Intervention: Device: Habitual Prosthesis
  • Experimental: Assist-Knee
    Experimental knee prosthesis
    Intervention: Device: Assist-Knee
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2019) 		3
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 26, 2020
Actual Primary Completion Date February 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04023045
Other Study ID Numbers  ICMJE 7826-01
1R43HD097826 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sarah Chang, Orthocare Innovations, LLC
Study Sponsor  ICMJE Orthocare Innovations, LLC
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Sarah Chang, PhD Orthocare Innovations, LLC
PRS Account Orthocare Innovations, LLC
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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