Trial Outcomes & Findings for Active Powered Prosthesis (APEX) for Spinal Cord Injury (NCT NCT03696927)

NCT ID: NCT03696927

Last Updated: 2022-11-15

Results Overview

Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: Two hours of in-clinic prototype evaluation
• Results posted on: 2022-11-15

Participant Flow

Participant milestones

Measure	User Focus Group Participants Human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C. 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.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Active Powered Prosthesis (APEX) for Spinal Cord Injury

Baseline characteristics by cohort

Measure	User Focus Group Participants n=4 Participants Human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Two hours of in-clinic prototype evaluation

Population: 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. Functions assessed include ability to use voice control features and controlling device to mimic performance of ADLs.

Users evaluate the usability and performance of the APEX device in completion of Activities of Daily Living (ADLs).

Outcome measures

Measure	User Focus Group Participants n=4 Participants Human subjects with spinal cord injury at levels C3 to C5, and ASIA Impairment Scale (AIS) A, B, or C. 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.
User Ability to Operate the APEX Device Change Device Modes using Voice Control	4 Participants
User Ability to Operate the APEX Device Control Device to Mimic ADL Performance on Manikin	4 Participants

Adverse Events

User Focus Group Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical and Product Management

Abilitech Medical

Phone: 833.225.3123

Email: info@abilitechmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place