Arm Weakness as a Consequence of Stroke
Conditions
Brief summary
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.
Interventions
DEVICECompliant 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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* greater than 6 months post-stroke * passive abduction to 90 degrees at shoulder * reduced active (retro)flexion/extension at shoulder when abducted at 90 degrees * reduced active flexion/extension at elbow
Exclusion criteria
* unable to give informed consent * unable to comprehend and follow instructions * have a condition (other than stroke) affecting sensorimotor function * show evidence of unilateral spatial neglect * unable to sit in a chair without armrests for 2 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reachable Workspace - Mean Distance From Trunk, All Motions | Assessed at baseline (without the device) and after approximately 60 minutes of use with the device. | 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. |
| Wolf Motor Function Test - Change in Functional Score by Task (WMFT) | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | 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. |
| Wolf Motor Function Test - Change in Completion Time by Task | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | 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. |
| Wolf Motor Function Test - Weight Lifted | Assessed at baseline (without the device) and after approximately 5 minutes of use with the device. | 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. |
| Percentage of Successful Motions | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | 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. |
| Reachable Workspace - Mean Distance From Trunk, Successful Motions | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | 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. |
| Reachable Workspace - Area, Successful Motions | Assessed at baseline (without the device) and after approximately 30 minutes of use with the device. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction Survey | After study procedures have been performed, on day 2 (up to 5 minutes to complete 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilot Phase Pilot testing by stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. | 1 |
| Evaluation Phase Stroke survivors with upper extremity motor impairments use a Compliant Passive Arm Support. | 11 |
| Total | 12 |
Baseline characteristics
| Characteristic | Pilot Phase | Evaluation Phase | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 7 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 4 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 6 Participants |
| Region of Enrollment United States | 1 Participants | 11 Participants | 12 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 11 |
| other Total, other adverse events | 0 / 1 | 0 / 11 |
| serious Total, serious adverse events | 0 / 1 | 0 / 11 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Evaluation Phase | Percentage of Successful Motions | No device | 57.5 percentage of motions | Standard Deviation 42.28 |
| Evaluation Phase | Percentage of Successful Motions | With device | 69.84 percentage of motions | Standard Deviation 45.07 |
Comparison: Difference in measurements from 'no device' (baseline) to 'with device.'p-value: 0.02Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Evaluation Phase | Reachable Workspace - Area, Successful Motions | No device | 0.078 m^2 | Standard Deviation 0.084 |
| Evaluation Phase | Reachable Workspace - Area, Successful Motions | With device | 0.082 m^2 | Standard Deviation 0.073 |
Comparison: Difference in measurements from 'no device' (baseline) to 'with device.'p-value: 0.48Wilcoxon (Mann-Whitney)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Evaluation Phase | Reachable Workspace - Mean Distance From Trunk, All Motions | No device | -0.14 meters | Standard Deviation 0.12 |
| Evaluation Phase | Reachable Workspace - Mean Distance From Trunk, All Motions | With device | -0.12 meters | Standard Deviation 0.12 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Evaluation Phase | Reachable Workspace - Mean Distance From Trunk, Successful Motions | No device | -0.07 meters | Standard Deviation 0.07 |
| Evaluation Phase | Reachable Workspace - Mean Distance From Trunk, Successful Motions | With device | -0.05 meters | Standard Deviation 0.07 |
Comparison: Difference in measurements from 'no device' (baseline) to 'with device.'p-value: 0.01ANOVA
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Evaluation Phase | Wolf Motor Function Test - Change in Completion Time by Task | Increased time | 3 Tasks |
| Evaluation Phase | Wolf Motor Function Test - Change in Completion Time by Task | No change | 0 Tasks |
| Evaluation Phase | Wolf Motor Function Test - Change in Completion Time by Task | Decreased time | 12 Tasks |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Evaluation Phase | Wolf Motor Function Test - Change in Functional Score by Task (WMFT) | Decreased functionality | 5 Tasks |
| Evaluation Phase | Wolf Motor Function Test - Change in Functional Score by Task (WMFT) | Increase functionality | 7 Tasks |
| Evaluation Phase | Wolf Motor Function Test - Change in Functional Score by Task (WMFT) | No change | 3 Tasks |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Evaluation Phase | Wolf Motor Function Test - Weight Lifted | No Device | 4.6 pounds | Standard Deviation 4.8 |
| Evaluation Phase | Wolf Motor Function Test - Weight Lifted | With Device | 6.1 pounds | Standard Deviation 4.8 |
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Evaluation Phase | Participant Satisfaction Survey | Impact | 3 Participants |
| Evaluation Phase | Participant Satisfaction Survey | Responsiveness | 2 Participants |
| Evaluation Phase | Participant Satisfaction Survey | Comfort | 4 Participants |
| Positive | Participant Satisfaction Survey | Comfort | 1 Participants |
| Positive | Participant Satisfaction Survey | Impact | 4 Participants |
| Positive | Participant Satisfaction Survey | Responsiveness | 6 Participants |
| Neutral | Participant Satisfaction Survey | Comfort | 0 Participants |
| Neutral | Participant Satisfaction Survey | Impact | 1 Participants |
| Neutral | Participant Satisfaction Survey | Responsiveness | 2 Participants |
| Negative | Participant Satisfaction Survey | Impact | 1 Participants |
| Negative | Participant Satisfaction Survey | Responsiveness | 0 Participants |
| Negative | Participant Satisfaction Survey | Comfort | 5 Participants |
| Very Negative | Participant Satisfaction Survey | Comfort | 0 Participants |
| Very Negative | Participant Satisfaction Survey | Impact | 1 Participants |
| Very Negative | Participant Satisfaction Survey | Responsiveness | 0 Participants |