Active Powered Prosthesis (APEX) for Spinal Cord Injury
NCT ID: NCT03696927
Last Updated: 2022-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
4 participants
INTERVENTIONAL
2018-08-29
2018-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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User Focus Group Participants
Target user population will be human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C.
Active Powered Prosthesis (APEX) for Spinal Cord Injury
The Active Powered Prosthesis (APEX) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Focus group participants will control the APEX device on a test manikin and provide feedback on the device design and function.
Interventions
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Active Powered Prosthesis (APEX) for Spinal Cord Injury
The Active Powered Prosthesis (APEX) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Focus group participants will control the APEX device on a test manikin and provide feedback on the device design and function.
Eligibility Criteria
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Inclusion Criteria
2. Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
3. Ability to provide informed consent
4. Age 18 or over
5. Selected for participation based on investigator discretion
Exclusion Criteria
2. Exhibit significant behavioral problems or impaired cognitive ability
3. Inability to provide consent
4. Non-English speaker
18 Years
ALL
No
Sponsors
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Allina Health System
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
AbiliTech Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jennifer L Theis, MS, OT/L
Role: PRINCIPAL_INVESTIGATOR
Allina Health System
Locations
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Allina Health Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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6100003-100 Rev A
Identifier Type: -
Identifier Source: org_study_id
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