Back to resultsActive Powered Prosthesis (APEX) for Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Powered Prosthesis (APEX) for Spinal Cord Injury
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injuries
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury at levels C3 to C5, and AIS A, B, or C
- Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
- Ability to provide informed consent
- Age 18 or over
- Selected for participation based on investigator discretion
Exclusion Criteria:
- Unable to follow instructions
- Exhibit significant behavioral problems or impaired cognitive ability
- Inability to provide consent
- Non-English speaker
Sites / Locations
- Allina Health Courage Kenny Rehabilitation Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
User Focus Group Participants
Arm Description
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.
Outcomes
Primary Outcome Measures
User Ability to Operate the APEX Device
Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
Secondary Outcome Measures
Full Information
NCT ID
NCT03696927
First Posted
September 17, 2018
Last Updated
October 25, 2022
Sponsor
AbiliTech Medical Inc.
Collaborators
Courage Kenny Rehabilitation Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03696927
Brief Title
Active Powered Prosthesis (APEX) for Spinal Cord Injury
Official Title
Active Powered Prosthesis (APEX) for Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbiliTech Medical Inc.
Collaborators
Courage Kenny Rehabilitation Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. The objective of this study is to perform focus groups with users and clinicians to evaluate a proof of concept active powered assistance device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
User Focus Group Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Powered Prosthesis (APEX) for Spinal Cord Injury
Intervention Description
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.
Primary Outcome Measure Information:
Title
User Ability to Operate the APEX Device
Description
Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
Time Frame
Two hours of in-clinic prototype evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury at levels C3 to C5, and AIS A, B, or C
Greater than 3-months post injury or surgery to the spinal column, arms, or shoulder
Ability to provide informed consent
Age 18 or over
Selected for participation based on investigator discretion
Exclusion Criteria:
Unable to follow instructions
Exhibit significant behavioral problems or impaired cognitive ability
Inability to provide consent
Non-English speaker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Theis, MS, OT/L
Organizational Affiliation
Courage Kenny Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allina Health Courage Kenny Rehabilitation Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Active Powered Prosthesis (APEX) for Spinal Cord Injury
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