Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-11-28
2024-11-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Participant with normal assistive device
Normal assistive device refers to the habitual assistive device that may be prescribed by a provider of care or no assistive device if the individual does not normally use.
No interventions assigned to this group
Participant with intervention
Intervention refers to investigational assistive devices or commercially available assistive devices that individuals may use during this study.
Assist-Knee
Investigational prosthetic knee-ankle device
Prosthetic Knee
Commercially available prosthetic knee devices
Prosthetic Ankle
Commercially available prosthetic ankle devices
Prosthetic Foot
Commercially available prosthetic foot devices
Ankle-Foot Orthosis
Commercially available ankle-foot orthosis devices
Interventions
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Assist-Knee
Investigational prosthetic knee-ankle device
Prosthetic Knee
Commercially available prosthetic knee devices
Prosthetic Ankle
Commercially available prosthetic ankle devices
Prosthetic Foot
Commercially available prosthetic foot devices
Ankle-Foot Orthosis
Commercially available ankle-foot orthosis devices
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
90 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Orthocare Innovations, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Arabian, PhD
Role: PRINCIPAL_INVESTIGATOR
Orthocare Innovations, LLC
Locations
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Orthocare Innovations, LLC
Edmonds, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AD-001
Identifier Type: -
Identifier Source: org_study_id
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