Active Powered Prosthesis (APEX) for Spinal Cord Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03696927|
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Active Powered Prosthesis (APEX) for Spinal Cord Injury|
|Actual Study Start Date :||August 29, 2018|
|Actual Primary Completion Date :||August 29, 2018|
|Actual Study Completion Date :||August 29, 2018|
Experimental: 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.
Device: 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.
- User ability to operate the APEX device [ Time Frame: Two hours of in-clinic prototype evaluation ]Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
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): NCT03696927
|United States, Minnesota|
|Allina Health Courage Kenny Rehabilitation Institute|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||Jennifer L Theis, MS, OT/L||Courage Kenny Rehabilitation Institute|