RecruitingNot ApplicableNCT05729061

Analysis of Human Movement With Assistive Devices


Sponsor

Orthocare Innovations, LLC

Enrollment

100 participants

Start Date

Nov 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research is to evaluate how people move about in different settings with different assistive devices or components, and to understand how people interact with different assistive technologies. Individuals that have limb weakness, limb paralysis, limb loss, and movement disorders are often provided assistive devices such as prostheses and orthoses to assist with mobility or use assistive technologies for purposes such as to regain muscle strength or retrain movements. It is important to understand the impact of these different assistive technologies on human movement for technology improvement and in preparation for commercialization. Because this research focuses on evaluating how different people move about in different settings with different assistive devices/components, there are different activities that may take place. These activities have been classified as (1) Movement Analysis in the Laboratory, (2) Movement Analysis Outside the Laboratory, (3) Usability Testing, and (4) Focus Groups. Each participant may or may not complete the same activities as the other participants. Each participant may or may not complete all of the activities. Participants may complete the activities more than once.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria15

  • Age 18 - 90 years
  • Has bilateral normal range of motion
  • Able to perform a variety of movement activities
  • Able to communicate and write individual perceptions in English
  • Able to provide written informed consent
  • Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
  • Age 18 - 90 years
  • Has a condition or diagnosis that results in limb weakness, limb paralysis, limb loss, or movement disorders
  • Medically stable
  • Has stable balance
  • Able to perform a variety of movement activities
  • Able to communicate and write individual perceptions in English
  • Able to provide written informed consent
  • Participants that will use a treadmill during data collection must also be able to walk independently and safely on a treadmill
  • Able to safely complete the movements being tested and/or safely use the assistive devices being tested

Exclusion Criteria6

  • Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may not represent a nondisabled condition
  • Pregnancy
  • Not able to read and understand English
  • Health issues (e.g., confounding injury, musculoskeletal, or cognitive) or other issues (e.g., transportation or schedule issues) that limit effective participation and/or may result in mixed effects of multiple sources of disability
  • Pregnancy
  • Not able to read and understand English

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Interventions

DEVICEAssist-Knee

Investigational prosthetic knee-ankle device

DEVICEProsthetic Knee

Commercially available prosthetic knee devices

DEVICEProsthetic Ankle

Commercially available prosthetic ankle devices

DEVICEProsthetic Foot

Commercially available prosthetic foot devices

DEVICEAnkle-Foot Orthosis

Commercially available ankle-foot orthosis devices


Locations(1)

Orthocare Innovations, LLC

Edmonds, Washington, United States

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NCT05729061


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