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.

Completed

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allina Health Courage Kenny Rehabilitation Institute

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Powered Prosthesis (APEX) for Spinal Cord Injury

Device

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

AbiliTech Medical Inc.

Industry

Collaborators

Allina Health System
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Oct 5, 2018
Registry last updated: Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed