Active Powered Prosthesis (APEX) for Spinal Cord Injury
2 other identifiers
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2018
CompletedFirst Submitted
Initial submission to the registry
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedResults Posted
Study results publicly available
November 15, 2022
CompletedNovember 15, 2022
October 1, 2022
Same day
September 17, 2018
September 26, 2022
October 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
User Ability to Operate the APEX Device
Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).
Two hours of in-clinic prototype evaluation
Study Arms (1)
User Focus Group Participants
EXPERIMENTALTarget user population will be human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to follow instructions
- Exhibit significant behavioral problems or impaired cognitive ability
- Inability to provide consent
- Non-English speaker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Allina Health Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, 55407, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical and Product Management
- Organization
- Abilitech Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer L Theis, MS, OT/L
Allina Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2018
First Posted
October 5, 2018
Study Start
August 29, 2018
Primary Completion
August 29, 2018
Study Completion
August 29, 2018
Last Updated
November 15, 2022
Results First Posted
November 15, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share