Spinal Cord Injuries
Conditions
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.
Interventions
DEVICEActive 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.
Sponsors
Allina Health System
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
AbiliTech Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Baseline characteristics
| Characteristic | User Focus Group Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| User Focus Group Participants | User Ability to Operate the APEX Device | Change Device Modes using Voice Control | 4 Participants |
| User Focus Group Participants | User Ability to Operate the APEX Device | Control Device to Mimic ADL Performance on Manikin | 4 Participants |