Active Powered Prosthesis (APEX) for Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury

• Registration Number: NCT03696927
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-29
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Results First Submitted: 2022-09-26
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-25
• Last Update Submitted: 2022-10-25
• Results First Posted: 2022-11-15
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
User Focus Group Participants	Active Powered Prosthesis (APEX) for Spinal Cord Injury	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.

Primary Outcome Measures

Name	Time	Method
User Ability to Operate the APEX Device	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).

Trial Locations

Locations (1)

Allina Health Courage Kenny Rehabilitation Institute; 🇺🇸 Minneapolis, Minnesota, United States