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Completed

NCT Number: NCT03696927

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.

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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

  1. 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.

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