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NCT03696927 Clinical Trial

Active Powered Prosthesis (APEX) for Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:
Active Powered Prosthesis (APEX) for Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03696927
Other study ID # 6100003-100 Rev A
Secondary ID R43HD094440
Status Completed
Phase N/A
First received
Last updated
Start date August 29, 2018
Est. completion date August 29, 2018

Study information
Verified date October 2022
Source AbiliTech Medical Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date August 29, 2018
Est. primary completion date August 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Spinal cord injury at levels C3 to C5, and AIS A, B, or C 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: 1. Unable to follow instructions 2. Exhibit significant behavioral problems or impaired cognitive ability 3. Inability to provide consent 4. Non-English speaker

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Allina Health Courage Kenny Rehabilitation Institute Minneapolis Minnesota

Sponsors (3)
Lead Sponsor Collaborator
AbiliTech Medical Inc. Courage Kenny Rehabilitation Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Two hours of in-clinic prototype evaluation
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