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Trial record 19 of 1166 for:    spinal cord injury

Active Powered Prosthesis (APEX) for Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03696927
Recruitment Status : Completed
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
Courage Kenny Rehabilitation Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
AbiliTech Medical Inc.

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Active Powered Prosthesis (APEX) for Spinal Cord Injury
Actual Study Start Date : August 29, 2018
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696927


Locations
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United States, Minnesota
Allina Health Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
AbiliTech Medical Inc.
Courage Kenny Rehabilitation Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Jennifer L Theis, MS, OT/L Courage Kenny Rehabilitation Institute

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Responsible Party: AbiliTech Medical Inc.
ClinicalTrials.gov Identifier: NCT03696927     History of Changes
Other Study ID Numbers: 6100003-100 Rev A
R43HD094440 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System