An interventional study of Compliant Passive Arm Support in Arm Weakness as a Consequence of Stroke, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Stanford University · Not applicable, Interventional, and Supportive care
The purpose of this study is to quantify the improvement of post- stroke individuals' ability to move their arms during and after robot assisted therapy.
While researchers know that robot assisted therapies improve motor performance over the course of weeks, they do not know how motor performance is affected over the course of minutes or hours. A better understanding of how robot assisted therapies affect motor performance on short time scales may help us to prescribe more effective therapy doses to maximize motor recovery after neurological injury.
The study will allow us to obtain a detailed understanding of the performance of the device as described above.
Stanford University is the lead sponsor of 2,162 studies on the registry; 429 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Stroke survivors with upper extremity motor impairments
Device: 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.
Wolf Motor Function Test - Change in Functional Score by Task (WMFT)
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.
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Wolf Motor Function Test - Change in Completion Time by Task
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.
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Wolf Motor Function Test - Weight Lifted
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.
Time frame: Assessed at baseline (without the device) and after approximately 5 minutes of use with the device.
Percentage of Successful Motions
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.
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Reachable Workspace - Mean Distance From Trunk, Successful Motions
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.
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Reachable Workspace - Area, Successful Motions
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.
Time frame: Assessed at baseline (without the device) and after approximately 30 minutes of use with the device.
Reachable Workspace - Mean Distance From Trunk, All Motions
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.
Time frame: Assessed at baseline (without the device) and after approximately 60 minutes of use with the device.
Participant Satisfaction Survey
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.
Time frame: After study procedures have been performed, on day 2 (up to 5 minutes to complete survey)
| Milestone | Pilot Phase | Evaluation Phase |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
| Milestone | Pilot Phase | Evaluation Phase |
|---|---|---|
| Started | 0 | 11 |
| Completed | 0 | 11 |
| Not completed | 0 | 0 |
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.
| Tasks | Evaluation Phase |
|---|---|
| Increase functionality | 7 |
| No change | 3 |
| Decreased functionality | 5 |
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.
| Tasks | Evaluation Phase |
|---|---|
| Increased time | 3 |
| No change | 0 |
| Decreased time | 12 |
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.
| pounds | Evaluation Phase |
|---|---|
| No Device | 4.6 ± 4.8 |
| With Device | 6.1 ± 4.8 |
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.
| percentage of motions | Evaluation Phase |
|---|---|
| No device | 57.5 ± 42.28 |
| With device | 69.84 ± 45.07 |
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.
| meters | Evaluation Phase |
|---|---|
| No device | -0.07 ± 0.07 |
| With device | -0.05 ± 0.07 |
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.
| m^2 | Evaluation Phase |
|---|---|
| No device | 0.078 ± 0.084 |
| With device | 0.082 ± 0.073 |
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.
| meters | Evaluation Phase |
|---|---|
| No device | -0.14 ± 0.12 |
| With device | -0.12 ± 0.12 |
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.
| Participants | Very Positive | Positive | Neutral | Negative | Very Negative |
|---|---|---|---|---|---|
| Impact | 3 | 4 | 1 | 1 | 1 |
| Comfort | 4 | 1 | 0 | 5 | 0 |
| Responsiveness | 2 | 6 | 2 | 0 | 0 |
Collected over 2 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot Phase | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Evaluation Phase | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | Pilot Phase | Evaluation Phase | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 4 | 4 |
| >=65 years | 1 | 7 | 8 |
| Sex: Female, Male(Participants) | Pilot Phase | Evaluation Phase | Total |
|---|---|---|---|
| Female | 0 | 3 | 3 |
| Male | 1 | 8 | 9 |
| Ethnicity (NIH/OMB)(Participants) | Pilot Phase | Evaluation Phase | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 11 | 12 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pilot Phase | Evaluation Phase | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 5 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 5 | 6 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Pilot Phase | Evaluation Phase | Total |
|---|---|---|---|
| United States | 1 | 11 | 12 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2022 to primary completion in Sep 2022, 1 month.
Results were first posted in Oct 2023, 1 year 1 month after primary completion.
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