Trial Outcomes & Findings for Effects of Post-Stroke Upper Extremity Assistance (NCT NCT05036642)
NCT ID: NCT05036642
Last Updated: 2023-10-25
Results Overview
Change reported as number of tasks where participants on average had increased functionality, no change, or decreased functionality. Lower functional scores are indicative of lower functional levels. The WMFT consists of 17 tasks: Forearm to table (side), Forearm to box (side), Extend elbow (to the side), Extend elbow (to the side) - with weight, Hand to table (front), Hand to box (front), Weight to box, Reach and retrieve, Lift can, Lift pencil, Lift paper clip, Stack checkers, Flip cards, Grip Strength, Turning key In lock, Fold towel, and Lift basket. Fifteen tasks were assessed for this outcome: task 7 (Weight to box) is reported in a separate analysis; task 14 (Grip strength) was excluded due to an inability to acquire the necessary equipment.
COMPLETED
NA
12 participants
Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
2023-10-25
Participant Flow
Participant milestones
| Measure |
Pilot Phase
Pilot testing by stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.
|
Evaluation Phase
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.
|
|---|---|---|
|
Pilot Phase
STARTED
|
1
|
0
|
|
Pilot Phase
COMPLETED
|
1
|
0
|
|
Pilot Phase
NOT COMPLETED
|
0
|
0
|
|
Evaluation Phase
STARTED
|
0
|
11
|
|
Evaluation Phase
COMPLETED
|
0
|
11
|
|
Evaluation Phase
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Post-Stroke Upper Extremity Assistance
Baseline characteristics by cohort
| Measure |
Pilot Phase
n=1 Participants
Pilot testing by stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Evaluation Phase
n=11 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Change reported as number of tasks where participants on average had increased functionality, no change, or decreased functionality. Lower functional scores are indicative of lower functional levels. The WMFT consists of 17 tasks: Forearm to table (side), Forearm to box (side), Extend elbow (to the side), Extend elbow (to the side) - with weight, Hand to table (front), Hand to box (front), Weight to box, Reach and retrieve, Lift can, Lift pencil, Lift paper clip, Stack checkers, Flip cards, Grip Strength, Turning key In lock, Fold towel, and Lift basket. Fifteen tasks were assessed for this outcome: task 7 (Weight to box) is reported in a separate analysis; task 14 (Grip strength) was excluded due to an inability to acquire the necessary equipment.
Outcome measures
| Measure |
Evaluation Phase
n=15 Tasks
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Wolf Motor Function Test - Change in Functional Score by Task (WMFT)
Increase functionality
|
7 Tasks
|
—
|
—
|
—
|
—
|
|
Wolf Motor Function Test - Change in Functional Score by Task (WMFT)
No change
|
3 Tasks
|
—
|
—
|
—
|
—
|
|
Wolf Motor Function Test - Change in Functional Score by Task (WMFT)
Decreased functionality
|
5 Tasks
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Change reported as number of tasks which participants on average performed with increased time, no change, or decreased time. If a participant was unable to complete the task, a time score of 120+ seconds was assigned and converted to 121 for calculation purposes. The WMFT consists of 17 tasks: Forearm to table (side), Forearm to box (side), Extend elbow (to the side), Extend elbow (to the side) - with weight, Hand to table (front), Hand to box (front), Weight to box, Reach and retrieve, Lift can, Lift pencil, Lift paper clip, Stack checkers, Flip cards, Grip Strength, Turning key In lock, Fold towel, and Lift basket. Fifteen tasks were assessed for this outcome: task 7 (Weight to box) is reported in a separate analysis; task 14 (Grip strength) was excluded due to an inability to acquire the necessary equipment.
Outcome measures
| Measure |
Evaluation Phase
n=15 Tasks
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Wolf Motor Function Test - Change in Completion Time by Task
Increased time
|
3 Tasks
|
—
|
—
|
—
|
—
|
|
Wolf Motor Function Test - Change in Completion Time by Task
No change
|
0 Tasks
|
—
|
—
|
—
|
—
|
|
Wolf Motor Function Test - Change in Completion Time by Task
Decreased time
|
12 Tasks
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 5 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Weight lifted (carried) in task 7 of the WMFT: Weight to box. In this assessment, the participant is seated and lifts weight to a box centered on a table in front of them, while keeping his/her back against the chair.
Outcome measures
| Measure |
Evaluation Phase
n=11 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Wolf Motor Function Test - Weight Lifted
No Device
|
4.6 pounds
Standard Deviation 4.8
|
—
|
—
|
—
|
—
|
|
Wolf Motor Function Test - Weight Lifted
With Device
|
6.1 pounds
Standard Deviation 4.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Participants are instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. The participant was asked to perform 6 motions (3 clockwise and 3 counterclockwise in randomized order). This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. Successful motion is defined as motion where any part of the arm is within 20cm of shoulder level. The percentage of motion in which successful motion occurred over the total motion was reported.
Outcome measures
| Measure |
Evaluation Phase
n=6 Motions
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Percentage of Successful Motions
No device
|
57.5 percentage of motions
Standard Deviation 42.28
|
—
|
—
|
—
|
—
|
|
Percentage of Successful Motions
With device
|
69.84 percentage of motions
Standard Deviation 45.07
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Participants are instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. Successful motion is defined as motion where any part of the arm is within 20cm of shoulder level. The distance from the wrist to the trunk was reported for successful motion. Distance closer to the trunk indicates greater ability to correctly perform the task. Negative numbers would indicate the arm was below the trunk; positive numbers would indicate the arm was above the trunk.
Outcome measures
| Measure |
Evaluation Phase
n=11 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Reachable Workspace - Mean Distance From Trunk, Successful Motions
No device
|
-0.07 meters
Standard Deviation 0.07
|
—
|
—
|
—
|
—
|
|
Reachable Workspace - Mean Distance From Trunk, Successful Motions
With device
|
-0.05 meters
Standard Deviation 0.07
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Participants will be instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. A larger workspace area indicates fewer upper extremity motor impairments.
Outcome measures
| Measure |
Evaluation Phase
n=11 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Reachable Workspace - Area, Successful Motions
No device
|
0.078 m^2
Standard Deviation 0.084
|
—
|
—
|
—
|
—
|
|
Reachable Workspace - Area, Successful Motions
With device
|
0.082 m^2
Standard Deviation 0.073
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Assessed at baseline (without the device) and after approximately 60 minutes of use with the device.Population: Data for this outcome were collected from participants in the Evaluation phase only.
Participants are instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they can reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm is tracked with motion capture. This protocol was originally developed by Sukal et al (2007); to asses post-stroke motor abilities. The distance from the wrist to the trunk was reported for all motion. Distance closer to the trunk indicates greater ability to correctly perform the task. Negative numbers would indicate the arm was below the trunk; positive numbers would indicate the arm was above the trunk.
Outcome measures
| Measure |
Evaluation Phase
n=11 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Reachable Workspace - Mean Distance From Trunk, All Motions
No device
|
-0.14 meters
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
|
Reachable Workspace - Mean Distance From Trunk, All Motions
With device
|
-0.12 meters
Standard Deviation 0.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: After study procedures have been performed, on day 2 (up to 5 minutes to complete survey)Population: Data for this outcome were collected from participants in the Evaluation phase only. Participants who completed the survey are included in the analysis.
Closing survey of participants satisfaction with the device (impact, comfort, and responsiveness). Participants rated the experience as very positive, positive, neutral, negative, or very negative.
Outcome measures
| Measure |
Evaluation Phase
n=10 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Positive
n=10 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Neutral
n=10 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Negative
n=10 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
Very Negative
n=10 Participants
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support.
|
|---|---|---|---|---|---|
|
Participant Satisfaction Survey
Impact
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participant Satisfaction Survey
Comfort
|
4 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
|
Participant Satisfaction Survey
Responsiveness
|
2 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Pilot Phase
Evaluation Phase
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place