Study Results
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View full resultsBasic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2019-07-15
2020-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
DEVICE_FEASIBILITY
NONE
Study Groups
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Habitual Prosthesis
Participant's prescribed prosthesis
Habitual Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.
Assist-Knee
Experimental knee prosthesis
Assist-Knee
Assist-Knee is an experimental lower limb knee prosthesis.
Interventions
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Assist-Knee
Assist-Knee is an experimental lower limb knee prosthesis.
Habitual Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
80 Years
ALL
No
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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Sarah Chang, PhD
Role: PRINCIPAL_INVESTIGATOR
Orthocare Innovations, LLC
Locations
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Orthocare Innovations, LLC
Edmonds, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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7826-01
Identifier Type: -
Identifier Source: org_study_id
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