Cerebrovascular Stroke
Conditions
Keywords
Sub-acute care, Robotics
Brief summary
The AMES device is designed to produce functional cortical changes by:(1) assisting the subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement sensation by vibrating the muscles during movement (enhanced sensation). The primary hypothesis is that the combination of assisted movement and enhanced sensation from muscle vibration can increase the amount of motor recovery in individuals disabled by a stroke.
Detailed description
Approximately 700,000 U.S. citizens have a stroke each year with about half ending up with significant motor disabilities. There are an estimated 5 million stroke survivors in the U.S., making strokes the leading cause of long-term disability in the U.S.. Existing rehabilitation therapies have not been effective in returning all stroke survivors to full motor recovery. The AMES device was designed to be able to provide therapy for the hand (fingers/wrist). In this 18 treatment sessions, double-blinded, control study, AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following a stroke. Those control subject who complete the Phase 1 placebo sessions will have the opportunity to cross-over to participate in a AMES treatment group for a Phase 2.
Interventions
DEVICEAMES device (test)
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
DEVICEAMES device (sham)
Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) in which the limb is moved, but no active assistance is provided by the subject and the vibration is delivered at a very low frequency to the shortening (i.e., rather than lengthening) muscle. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.
DEVICEAMES device (crossover)
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.
Sponsors
Northwest Medical Rehabilitation, Spokane, WA
Emory University
University of California, San Francisco
Shirley Ryan AbilityLab
Eisenhower Medical Center
Legacy Health System
AMES Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Single crossover for only the control group participants from the controlled part of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual weakness in the arm and/or leg. * First time ever stroke or previous stroke with complete resolution of motor deficit, occurring ≤4 months prior to subject enrollment. * Age 18-80 years old. * Moderate to severe lower-extremity paresis (defined as a leg motor Fugl-Meyer score of ≥6 and ≤22 out of a possible 34. * Moderate to severe upper-extremity paresis (defined as an arm motor Fugl-Meyer score of ≥6 and ≤43 out of a possible 66. * Visible voluntary movement of the ankle in at least one direction: dorsiflexion or plantarflexion for the ankle and flexion or extension for the hand. * At least partially functioning proprioception from the paretic arm or leg-capable of correctly identifying, ≥70% of the time, the direction of passive joint rotation (i.e., flexion-extension) with eyes closed. * Physically and cognitively capable of consenting to and complying with the protocol. * Score of \<19 out of 63 on the 21-question version of the Beck Depression Inventory. * Subject or legally authorized representative must be capable of providing informed consent.-
Exclusion criteria
* Complete flaccidity of the hand, wrist, and ankle. * Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or leg or resulting in pain in either the arm or leg. * Spinal cord injury, arthritis, or fractures of affected limbs that have resulted in loss of range of motion. * Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the limb being considered for testing. * Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance. * Major active psychiatric disorder. * Severe apraxia; inability to understand verbal (English) directions; or inability to communicate adequately with study personnel. * Size of arm or leg incompatible with the AMES device. * Severe contractures or decreased range of motion that would prohibit comfortable positioning or tolerance of the device * Skin condition not able to tolerate use of the AMES device. * Any progressive neurodegenerative disorder affecting the motor system. * Uncontrolled seizure disorder. * Current abuse of alcohol or drugs. * Terminal illness with anticipated survival of \<12 months. * Current or planned concurrent participation in another study or clinical trial. * NIH Stroke Scale, following scores: Item 1a \> 0; Item 1c \> 0; Item 2 \> 0; Item 3 \> 0; Item 9 \> 2; Item 10 \> 1; Item 11 \> 1 (based on exam by Study Physician). * Intent to receive Botox injections, initiation of antispasmodic medication, or use any other robotic (e.g., MANUS, Locomat) or stimulation device (e.g., Bioness) while participating in the AMES trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment Upper Limb Portion | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Comprehensive measure of upper limb impairment; minimum score = 0, maximum score = 66; higher score means better outcome. Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rancho Los Amigos Functional Test | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Upper limb functional movement. Outcome measure indicates how many of 17 functional tasks could be completed. Minimum score = 0, maximum score = 17. Higher number means better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Spasticity (Modified Ashworth) Scale | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Joint impedance of the fingers+wrist combined and that of the elbow. Outcome measure consists of the sum of 4 scores: (1) hand/wrist flexion, (2) hand/wrist extension, (3) elbow flexion, (4) elbow extension. Minimum value = 0, maximum value = 20. Higher score means worse outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Active Motion Test Grasp | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Ability to track a moving target with active grasp extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Active Motion Wrist | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Ability to track a moving target with active wrist extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Stroke Impact Scale | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Activities of daily living questionnaire for stroke patients. Minimum overall score = 0, maximum overall score = 800. Higher scores mean better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Strength Grasp Extension | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Isometric grasp extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Strength Wrist Flexion | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Isometric wrist flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Strength Wrist Extension | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Isometric wrist extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
| Strength Grasp Flexion | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). | Isometric grasp flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over. |
Countries
United States
Participant flow
Pre-assignment details
Some participants enrolled and assigned to the test or control group dropped out of the study. Each drop-out was encouraged to participate in a post-treatment evaluation, even though the standard course of treatment (i.e., 18 one-half hour sessions) was not completed. The data from participants who complied with this request were included in the analysis. Those not complying were not included. However, baseline values reported here include baseline data from all drop-out participants.
Participants by arm
| Arm | Count |
|---|---|
| Test-Phase 1 The Test Group receives 18 half-hour AMES (Assisted Movement with Enhanced Sensation) treatments with the AMES device (Test) in which the hand or wrist is moved, and the subject assists the motion while vibration (60 pulses/sec) is applied to the lengthening muscle. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
AMES device (test): Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke. | 44 |
| Control-Phase 1 Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) programed to provide placebo therapy. Each treatment session consisting of 30 minutes of sham therapy. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
AMES device (sham): Eighteen treatment sessions for each qualifying subject limb using the AMES device (sham) in which the limb is moved, but no active assistance is provided by the subject and the vibration is delivered at a very low frequency to the shortening (i.e., rather than lengthening) muscle. Each treatment session to provide thirty minutes of the placebo form of AMES therapy. | 39 |
| Total | 83 |
Baseline characteristics
| Characteristic | Control-Phase 1 | Total | Test-Phase 1 |
|---|---|---|---|
| Active Motion Test Grasp | 10.0 Seconds STANDARD_DEVIATION 6.7 | 9.9 Seconds STANDARD_DEVIATION 5.5 | 9.8 Seconds STANDARD_DEVIATION 4.9 |
| Active Motion Wrist Test | 17.3 Seconds STANDARD_DEVIATION 11.3 | 17.4 Seconds STANDARD_DEVIATION 10 | 17.6 Seconds STANDARD_DEVIATION 10.7 |
| Age, Continuous | 57.7 years STANDARD_DEVIATION 12.9 | 57.0 years STANDARD_DEVIATION 12.8 | 56.3 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 68 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Fugl-Meyer Assessment | 23.7 units on a scale STANDARD_DEVIATION 11.2 | 22.5 units on a scale STANDARD_DEVIATION 10.9 | 20.9 units on a scale STANDARD_DEVIATION 9.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 23 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 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 | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 22 Participants | 47 Participants | 25 Participants |
| Rancho Los Amigos Functional Test | 5.9 Number of tasks completed STANDARD_DEVIATION 4.5 | 5.3 Number of tasks completed STANDARD_DEVIATION 4.1 | 4.8 Number of tasks completed STANDARD_DEVIATION 3.7 |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 52 Participants | 29 Participants |
| Spasticity (Modified Ashworth) Scale | 4.6 units on a scale STANDARD_DEVIATION 3 | 4.3 units on a scale STANDARD_DEVIATION 3 | 4.1 units on a scale STANDARD_DEVIATION 3 |
| Strength Grasp Extension | 2.5 Newton-meters STANDARD_DEVIATION 6.2 | 2.6 Newton-meters STANDARD_DEVIATION 5.3 | 2.6 Newton-meters STANDARD_DEVIATION 4.6 |
| Strength Grasp Flexion | 16.4 Newton meters STANDARD_DEVIATION 19.9 | 15.4 Newton meters STANDARD_DEVIATION 16.8 | 14.6 Newton meters STANDARD_DEVIATION 14.3 |
| Strength Wrist Extension | 10.5 Newton-meters STANDARD_DEVIATION 14.6 | 10.9 Newton-meters STANDARD_DEVIATION 14.7 | 11.3 Newton-meters STANDARD_DEVIATION 14.8 |
| Strength Wrist Flexion | 36.5 Newton-meters STANDARD_DEVIATION 39.4 | 33.9 Newton-meters STANDARD_DEVIATION 33 | 31.7 Newton-meters STANDARD_DEVIATION 27.4 |
| Stroke Impact Scale | 500.3 units on a scale STANDARD_DEVIATION 92.9 | 503.8 units on a scale STANDARD_DEVIATION 86.5 | 506.8 units on a scale STANDARD_DEVIATION 80.9 |
| Stroke Type Hemorrhagic or Ischemic Plus Hemorrhagic | 5 Participants | 12 Participants | 7 Participants |
| Stroke Type Ischemic | 34 Participants | 71 Participants | 37 Participants |
| Study Site Site 1 | 7 Participants | 15 Participants | 8 Participants |
| Study Site Site 2 | 0 Participants | 1 Participants | 1 Participants |
| Study Site Site 3 | 9 Participants | 19 Participants | 10 Participants |
| Study Site Site 4 | 1 Participants | 1 Participants | 0 Participants |
| Study Site Site 5 | 3 Participants | 8 Participants | 5 Participants |
| Study Site Site 6 | 19 Participants | 39 Participants | 20 Participants |
| Time Since Stroke at Baseline | 11.3 Weeks STANDARD_DEVIATION 5 | 11.5 Weeks STANDARD_DEVIATION 5.4 | 11.8 Weeks STANDARD_DEVIATION 5.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 39 | 0 / 27 |
| other Total, other adverse events | 1 / 44 | 2 / 39 | 1 / 27 |
| serious Total, serious adverse events | 0 / 44 | 0 / 39 | 0 / 27 |
Outcome results
Primary
Fugl-Meyer Assessment Upper Limb Portion
Comprehensive measure of upper limb impairment; minimum score = 0, maximum score = 66; higher score means better outcome. Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Fugl-Meyer Assessment Upper Limb Portion | 10.8 units on a scale | Standard Deviation 7.4 |
| Control-Phase 1 | Fugl-Meyer Assessment Upper Limb Portion | 6.4 units on a scale | Standard Deviation 7.7 |
| Crossover-Phase 2 | Fugl-Meyer Assessment Upper Limb Portion | 4.7 units on a scale | Standard Deviation 6.7 |
p-value: 0.01ANCOVA
p-value: 0.003ANCOVA
Secondary
Active Motion Test Grasp
Ability to track a moving target with active grasp extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Active Motion Test Grasp | 2.6 seconds | Standard Deviation 4.1 |
| Control-Phase 1 | Active Motion Test Grasp | 1.5 seconds | Standard Deviation 4.4 |
| Crossover-Phase 2 | Active Motion Test Grasp | 2.4 seconds | Standard Deviation 6.3 |
p-value: 0.28ANCOVA
p-value: 0.09ANCOVA
Secondary
Active Motion Wrist
Ability to track a moving target with active wrist extension and flexion, measured as the total time in the target, in seconds. Outcome measure represents the change score from baseline to post-treatment. Minimum score = 0, maximum score = 40 s. Higher scores indicate better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Active Motion Wrist | 4.4 seconds | Standard Deviation 5.8 |
| Control-Phase 1 | Active Motion Wrist | 2.7 seconds | Standard Deviation 4.4 |
| Crossover-Phase 2 | Active Motion Wrist | 1.9 seconds | Standard Deviation 5.2 |
p-value: 0.18ANCOVA
p-value: 0.1ANCOVA
Secondary
Rancho Los Amigos Functional Test
Upper limb functional movement. Outcome measure indicates how many of 17 functional tasks could be completed. Minimum score = 0, maximum score = 17. Higher number means better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Rancho Los Amigos Functional Test | 3.5 units on a scale | Standard Deviation 4.3 |
| Control-Phase 1 | Rancho Los Amigos Functional Test | 2.1 units on a scale | Standard Deviation 3.4 |
| Crossover-Phase 2 | Rancho Los Amigos Functional Test | -0.6 units on a scale | Standard Deviation 2 |
p-value: 0.17ANCOVA
p-value: 0.17ANCOVA
Secondary
Spasticity (Modified Ashworth) Scale
Joint impedance of the fingers+wrist combined and that of the elbow. Outcome measure consists of the sum of 4 scores: (1) hand/wrist flexion, (2) hand/wrist extension, (3) elbow flexion, (4) elbow extension. Minimum value = 0, maximum value = 20. Higher score means worse outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Spasticity (Modified Ashworth) Scale | 0.0 units on a scale | Standard Deviation 2.1 |
| Control-Phase 1 | Spasticity (Modified Ashworth) Scale | -0.6 units on a scale | Standard Deviation 2.9 |
| Crossover-Phase 2 | Spasticity (Modified Ashworth) Scale | -0.6 units on a scale | Standard Deviation 2 |
p-value: 0.83ANCOVA
p-value: 0.83ANCOVA
Secondary
Strength Grasp Extension
Isometric grasp extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Strength Grasp Extension | 4.2 Newton-meter | Standard Deviation 0.6 |
| Control-Phase 1 | Strength Grasp Extension | 4.9 Newton-meter | Standard Deviation 0.6 |
| Crossover-Phase 2 | Strength Grasp Extension | 4.3 Newton-meter | Standard Deviation 7.6 |
p-value: 0.47ANCOVA
p-value: 0.015ANCOVA
Secondary
Strength Grasp Flexion
Isometric grasp flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Strength Grasp Flexion | 26.3 Newton-meter | Standard Deviation 1.6 |
| Control-Phase 1 | Strength Grasp Flexion | 24.6 Newton-meter | Standard Deviation 1.7 |
| Crossover-Phase 2 | Strength Grasp Flexion | 8.5 Newton-meter | Standard Deviation 11.9 |
p-value: 0.45ANCOVA
p-value: 0.003ANCOVA
Secondary
Strength Wrist Extension
Isometric wrist extension strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Strength Wrist Extension | 20.7 Newton-meter | Standard Deviation 1.5 |
| Control-Phase 1 | Strength Wrist Extension | 18.3 Newton-meter | Standard Deviation 1.6 |
| Crossover-Phase 2 | Strength Wrist Extension | 8.9 Newton-meter | Standard Deviation 19.8 |
p-value: 0.27ANCOVA
p-value: 0.045ANCOVA
Secondary
Strength Wrist Flexion
Isometric wrist flexion strength. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: participant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Strength Wrist Flexion | 53.8 Newton-meter | Standard Deviation 2.6 |
| Control-Phase 1 | Strength Wrist Flexion | 46.2 Newton-meter | Standard Deviation 2.7 |
| Crossover-Phase 2 | Strength Wrist Flexion | 16.2 Newton-meter | Standard Deviation 21.1 |
p-value: 0.05ANCOVA
p-value: 0.002ANCOVA
Secondary
Stroke Impact Scale
Activities of daily living questionnaire for stroke patients. Minimum overall score = 0, maximum overall score = 800. Higher scores mean better outcome. Intent is to report a change from baseline to post-treatment Phase 1 for both Test Group subjects and Control Group subjects, and to report a change from post-treatment Phase 1 to post-crossover treatment Phase 2 for Control Group subjects who elected to cross over.
Time frame: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test-Phase 1 | Stroke Impact Scale | 14.6 units on a scale | Standard Deviation 28.5 |
| Control-Phase 1 | Stroke Impact Scale | 10.7 units on a scale | Standard Deviation 15.2 |
| Crossover-Phase 2 | Stroke Impact Scale | 46.2 units on a scale | Standard Deviation 32.4 |
p-value: 1ANCOVA
p-value: 0.06ANCOVA