Active Powered Prosthesis (APEX) for Spinal Cord Injury

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Allina Health Courage Kenny Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AbiliTech Medical Inc.
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Courage Kenny Rehabilitation Institute
• Investigators: Principal Investigator: Jennifer L Theis, MS, OT/L, Courage Kenny Rehabilitation Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): August 29, 2018
• Study Completion (Actual): August 29, 2018

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 6100003-100 Rev A; R43HD094440 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes