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Assist-Knee: Energy-Harvesting Knee Prosthesis

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ClinicalTrials.gov Identifier: NCT04023045
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Sarah Chang, Orthocare Innovations, LLC

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

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.




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.



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023045


Contacts
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Contact: Sarah Chang, PhD 425-771-0797 ext 1007 schang@orthocareinnovations.com

Locations
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United States, Washington
Orthocare Innovations, LLC Not yet recruiting
Edmonds, Washington, United States, 98020
Contact: Sarah Chang, PhD    425-771-0797 ext 1007    schang@orthocareinnovations.com   
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

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Responsible Party: Sarah Chang, Director of Research & Development, Orthocare Innovations, LLC
ClinicalTrials.gov Identifier: NCT04023045     History of Changes
Other Study ID Numbers: 7826-01
1R43HD097826 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No