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| ID | Type | Description | Link |
|---|---|---|---|
| SNI-BI1-02 | Other Grant/Funding Number | Stanford Neurosciences Institute |
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The aim of this study is to show that a wearable compliant arm support consisting of inflatable bladders with adjustable straps to connect them to the waist and arm can meaningfully increase the reachable workspace of persons with post-stroke arm weakness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke survivors | Experimental | Stroke survivors with upper extremity motor impairments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| compliant support | Device | Participants will be given compliant arm support and their reachable workspace measured |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Reachable Workspace | Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters). | baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Biceps Activation | Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies. | baseline and while using support device (up to 10 seconds per assessment) |
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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 |
|---|---|---|---|
| Background | Simpson CS, Okamura AM, and Hawkes EW. Exomuscle: An inflatable device for shoulder abduction support. 2017 IEEE International Conference on Robotics and Automation (ICRA) 2017; pp. 6651-6657. | ||
| Result | Simpson C, Huerta B, Sketch S, Lansberg M, Hawkes E, and Okamura A. Upper Extremity Exomuscle for Shoulder Abduction Support. IEEE Transactions on Medical Robotics and Bionics. 2020; 2(3):474-484. |
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Participants were screened to include only those whose most recent stroke occurred more than 6 months before the study date and to exclude those with conflating health problems, sensory deficits, or that experience pain during passive movements of the arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Stroke survivors with upper extremity motor impairments |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Stroke survivors with upper extremity motor impairments |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change From Baseline in Reachable Workspace | Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters). | Posted | Mean | Standard Deviation | percent change | baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment) |
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Up to 3 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 | All Participants | Stroke survivors with upper extremity motor impairments | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cole Simpson | Stanford University | 4049077708 | cole.simpson@stanford.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 8, 2021 | Jan 15, 2021 | Prot_001.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Fugl-Meyer Assessment of sensorimotor function | The Fugl-Meyer Assessment of sensorimotor function is an index for assessing sensory and motor ability after a stroke. Our study considered only the upper extremity portion of this index. This index consists of a series of tasks that are individually assessed by the experimenter on a scale from 0 to 2 where 0 indicates inability to perform the task and 2 indicates faultless execution. The scores of these tasks are summed with a minimum score of 0 indicating severe sensorimotor impairments and a maximum score of 66 indicating no observable sensorimotor impairments. | Mean | Standard Deviation | units on a scale |
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| Correct scapulohumeral rhythm | To reduce the risks of adverse events during experimentation, participants were screened by the experimenter for correct scapulohumeral rhythm. Participants were asked to flex the shoulder from 0˚ (arm by the side) to 90˚ (arm parallel to the floor) while the experimenter examined the motion of the scapula. Participants were classified as having correct scapulohumeral rhythm if the scapula began to rotate with shoulder flexion above approximately 30˚ as is typical in people with no sensorimotor impairments. | Count of Participants | Participants |
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| Spatial neglect | Some stroke survivors experience an unawareness of portions of space, a phenomenon called spatial neglect. Spatial neglect was tested clinically by wiggling fingers for two seconds in one or both visual fields (six trials). Neglect was considered to be present when a participant failed at least once to accurately identify the stimulus. | Count of Participants | Participants |
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| Reachable workspace | Participants were instructed to individually flex and extend the elbow and shoulder to trace the largest possible circle that they could reach while keeping the hand and elbow raised to the height of the shoulder while the motion of the arm was tracked with motion capture. This protocol was originally developed by Sukal et al., 2007; PubMed ID: 17634933 to asses post-stroke motor abilities. A larger workspace area indicates fewer upper extremity motor impairments. | Mean | Standard Deviation | m^2 |
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| Biceps activation | Activity in the biceps muscle can become erroneously coupled with activity in the deltoid muscles after a stroke, limiting motor abilities. More information can be found in Beer et al., 2017, PubMed ID: 17486581. To assess the extent of such coupling, we replicated the experiment developed by Ellis et al., 2017, PubMed ID: 28558314, in which the activity of the biceps muscle is measured with surface electromyography while the arm is placed in a posture that activates the deltoid muscle. Larger values of activity indicate more coupling, which may correlate with motor impairment. | Mean | Standard Deviation | mV |
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| Secondary | Percent Change From Baseline in Biceps Activation | Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies. | Posted | Mean | Standard Deviation | percent change | baseline and while using support device (up to 10 seconds per assessment) |
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| 6 |
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| 6 |
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