Active Powered Prosthesis (APEX) for Spinal Cord Injury

Abilitech Medical

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury

Study type: Interventional

Funder types: Industry; Other; NIH

Identifiers

NCT03696927

R43HD094440 (U.S. NIH Grant/Contract)

6100003-100 Rev A

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

User Focus Group Participants

Experimental group

Description:

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.

Treatment:

Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury