Arm Weakness as a Consequence of Stroke
Conditions
Brief summary
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.
Interventions
DEVICEcompliant support
Participants will be given compliant arm support and their reachable workspace measured
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 to 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 |
|---|---|---|
| Percent Change From Baseline in Reachable Workspace | baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment) | Reachable workspace was measured using a PhaseSpace motion capture system, recorded as an area (in square meters). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Biceps Activation | baseline and while using support device (up to 10 seconds per assessment) | Biceps activation measured using surface electromyography during an isometric hold to approximate the contributions of erroneous flexor synergies. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Stroke survivors with upper extremity motor impairments | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 10 | — |
| Biceps activation | 0.19 mV STANDARD_DEVIATION 0.25 | — |
| Correct scapulohumeral rhythm | 6 Participants | — |
| Fugl-Meyer Assessment of sensorimotor function | 27 units on a scale STANDARD_DEVIATION 13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Reachable workspace | 0.10 m^2 STANDARD_DEVIATION 0.11 | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
| Spatial neglect | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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).
Time frame: baseline, while using support device, and 30 minutes following removal of support device (up to 4 minutes per assessment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Percent Change From Baseline in Reachable Workspace | On support device | 27 percent change | Standard Deviation 84 |
| All Participants | Percent Change From Baseline in Reachable Workspace | Post support device | -71 percent change | Standard Deviation 41 |
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.
Time frame: baseline and while using support device (up to 10 seconds per assessment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Percent Change From Baseline in Biceps Activation | -16 percent change | Standard Deviation 71 |