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| ID | Type | Description | Link |
|---|---|---|---|
| SNI-BI1-02 | Other Grant/Funding Number | Stanford Neurosciences Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke Survivors | Experimental | Stroke survivors with upper extremity motor impairments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compliant Passive Arm Support | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Assessed at baseline (without the device) and after approximately 5 minutes of use with the device. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After study procedures have been performed, on day 2 (up to 5 minutes to complete survey) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Okamura | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University CHARM Lab | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17634933 | Background | Sukal TM, Ellis MD, Dewald JP. Shoulder abduction-induced reductions in reaching work area following hemiparetic stroke: neuroscientific implications. Exp Brain Res. 2007 Nov;183(2):215-23. doi: 10.1007/s00221-007-1029-6. Epub 2007 Jul 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pilot Phase |
| |||||||||||||
| Evaluation Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pilot Phase | Pilot testing by stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. |
| BG001 | Evaluation Phase | Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Count of Units | Tasks | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | Tasks | Tasks |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pilot Phase | Pilot testing by stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Okamura | Stanford University | (650) 723-3148 | aokamura@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 8, 2022 | Sep 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2023 | Sep 6, 2023 | SAP_001.pdf |
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|
| 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. | 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. | 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. | 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. | Assessed at baseline (without the device) and after approximately 60 minutes of use with the device. |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Evaluation Phase |
Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. |
|
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| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Count of Units | Tasks | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | Tasks | Tasks |
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| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Mean | Standard Deviation | pounds | Assessed at baseline (without the device) and after approximately 5 minutes of use with the device. |
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| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Mean | Standard Deviation | percentage of motions | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | Motions | Motions |
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| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Mean | Standard Deviation | meters | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. |
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| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Mean | Standard Deviation | m^2 | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. |
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| Primary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. | Posted | Mean | Standard Deviation | meters | Assessed at baseline (without the device) and after approximately 60 minutes of use with the device. |
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| Secondary | 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. | Data for this outcome were collected from participants in the Evaluation phase only. Participants who completed the survey are included in the analysis. | Posted | Count of Participants | Participants | After study procedures have been performed, on day 2 (up to 5 minutes to complete survey) |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Evaluation Phase | Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. | 0 | 11 | 0 | 11 | 0 | 11 |
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| Title | Measurements |
|---|---|
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| Comfort |
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| Responsiveness |
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