N/A
N=4
Active Powered Prosthesis (APEX) for Spinal Cord Injury
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03696927 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: User Ability to Operate the APEX Device — 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Powered Prosthesis (APEX) for Spinal Cord Injury (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbiliTech Medical Inc.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY User Ability to Operate the APEX Device |
4; 4 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03696927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.