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| Name | Class |
|---|---|
| Northwest Medical Rehabilitation, Spokane, WA | UNKNOWN |
| Emory University | OTHER |
| University of California, San Francisco | OTHER |
| Shirley Ryan AbilityLab |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test-Phase 1 | Experimental | 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. |
|
| Control-Phase 1 | Sham Comparator | 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. |
|
| Crossover-Phase 2 | Active Comparator | Original Control Group receives 18 half-hour crossover treatments with the AMES device (Crossover) 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 each session one-half hour in length. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMES device (test) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J. Cordo, PhD | AMES Technology Inc./ Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | United States | ||
| UCSF School of Medicine- Physical Therapy and Rehabilitation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35067125 | Derived | Cordo P, Wolf S, Rymer WZ, Byl N, Stanek K, Hayes JR. Assisted Movement With Proprioceptive Stimulation Augments Recovery From Moderate-To-Severe Upper Limb Impairment During Subacute Stroke Period: A Randomized Clinical Trial. Neurorehabil Neural Repair. 2022 Mar;36(3):239-250. doi: 10.1177/15459683211063159. Epub 2022 Jan 24. |
| Label | URL |
|---|---|
| Study sponsor AMES Technology, Inc. website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Crossover-Phase 2 | Original Control Group receives 18 half-hour crossover treatments with the AMES device (Crossover) 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 each session one-half hour in length. AMES 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Controlled Period |
| |||||||||||||
| Crossover Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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. | Participants | Posted | Mean | Standard Deviation | units on a scale | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
|
Adverse event data were collected over a period of each participant's period of participation in the study. For participants in the Test group, and those in the Control group who chose not to cross over, the time frame was 6-9 weeks. For those Control group participants who crossed over, the time frame was 9-14 weeks.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin abrasion from vibrator probe | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Cordo | AMES Technology, Inc. | 503 970 6129 | pcordo@amesdevices.com |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018592 | Cross-Over Studies |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| OTHER |
| Eisenhower Medical Center | OTHER |
| Legacy Health System | OTHER |
Single crossover for only the control group participants from the controlled part of the study.
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|
| AMES device (sham) | Device | 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. |
|
| AMES device (crossover) | Device | 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. |
|
| Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| 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. | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
| San Francisco |
| California |
| 94123 |
| United States |
| Emory University Dept of Rehabilitation Medicine/School of Medicine | Atlanta | Georgia | 30322 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| NW Medical Rehabilitation | Spokane | Washington | 99202 | United States |
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Stroke Type | Count of Participants | Participants |
|
| Study Site | Count of Participants | Participants |
|
| Time Since Stroke at Baseline | Mean | Standard Deviation | Weeks |
|
| Active Motion Test Grasp | Performance analysis was based on the total time (in seconds) during the test that the subject was able to keep the tracking line, which represented the subject's joint angle, within the moving target. Intent is to report a change from baseline. | Two drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test. | Mean | Standard Deviation | Seconds |
|
| Fugl-Meyer Assessment | This baseline measure was obtained during each candidate subject's evaluation of eligibility for enrollment in the study. Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Scores were obtained for each of 7 categories of evaluation and summed for a final score. The range of possible scores for this measure is 0-66, with 0 representing no motor function and 66 representing normal motor function. | Mean | Standard Deviation | units on a scale |
|
| Spasticity (Modified Ashworth) Scale | Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Spasticity is represented by the sum of 4 individual measures (finger and wrist flexion, finger and wrist extension, elbow flexion, and elbow extension). Each individual measure represents the resistance of the joint to passive motion. The range of possible scores for each joint is 0-5 with 5 representing the most resistance and 0 representing normal resistance. | Mean | Standard Deviation | units on a scale |
|
| Strength Grasp Flexion | Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Maximum grasping strength was measured 3 times (trials), in succession, at the end of each training session. The baseline measure of grasp flexion strength consists of the average of the 9 "squeeze" strength trials performed during the first 3 training sessions (i.e., 3 trials in each). | Two control group drop-out participants did not contribute baselines scores on this test. | Mean | Standard Deviation | Newton meters |
|
| Strength Wrist Flexion | Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Maximum wrist flexion strength was measured 3 times (trials), in succession, at the end of each training session. The baseline measure of wrist flexion strength consists of the average of the 9 wrist flexion strength trials performed during the first 3 training sessions (i.e., 3 trials in each). | Two test group drop-out and one control group drop-out participants did not contribute baselines scores on this test. | Mean | Standard Deviation | Newton-meters |
|
| Strength Grasp Extension | Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Maximum hand-opening strength was measured 3 times (trials), in succession, at the end of each training session. The baseline measure of finger-thumb extension strength consists of the average of the 9 "hand-opening" strength trials performed during the first 3 training sessions (i.e., 3 trials in each). | Two control group drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test. | Mean | Standard Deviation | Newton-meters |
|
| Strength Wrist Extension | Outcome measure represents the difference between post-treatment and baseline (i.e., change score). Maximum wrist extension strength was measured 3 times (trials), in succession, at the end of each training session. The baseline measure of grasp flexion strength consists of the average of the 9 wrist extension strength trials performed during the first 3 training sessions (i.e., 3 trials in each). | One test group drop-out and two control group drop-out participants did not contribute baselines scores on this test. | Mean | Standard Deviation | Newton-meters |
|
| Stroke Impact Scale | A self-reporting assessment of functionality across 8 different domains (e.g., strength, communication, memory). Each domain consists of 4-10 questions,each question scored from 1-5 representing the spectrum from "could not do it at all" to "not difficult at all." A total score for all 8 domains is obtained as follows: Total=[(raw score-lowest possible score)/possible raw score] x 100. Intent is to report a change from baseline. | A site inadvertently omitted this test with one test group subject and one control group subject. | Mean | Standard Deviation | units on a scale |
|
| Rancho Los Amigos Functional Test | This test measures the ability to manipulate objects in everyday functional tasks. A total of 17 different tasks are attempted by each subject. The test quantifies both the ability to perform the task at all and, if performed, the quality of performance. Only the number of tasks that could be performed at any level were analyzed. The criteria distinguishing non-performance from performance are well defined. Intent is to report change from baseline. | A site inadvertently omitted this test on one control group participant. | Mean | Standard Deviation | Number of tasks completed |
|
| Active Motion Wrist Test | Performance analysis was based on the total time (in seconds) during the test that the subject was able to keep the tracking line, which represented the subject's joint angle, within the moving target. Intent is to report change from baseline. | One test group drop-out and two control group drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test. | Mean | Standard Deviation | Seconds |
|
| OG001 | 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. |
| OG002 | Crossover-Phase 2 | Original Control Group receives 18 half-hour crossover treatments with the AMES device (Crossover) 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 each session one-half hour in length. AMES 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. |
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| 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. | Participants | Posted | Mean | Standard Deviation | units on a scale | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participants | Posted | Mean | Standard Deviation | units on a scale | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participants | Posted | Mean | Standard Deviation | units on a scale | Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participants | Posted | Mean | Standard Deviation | seconds | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participants | Posted | Mean | Standard Deviation | seconds | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participants | Posted | Mean | Standard Deviation | Newton-meter | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participants | Posted | Mean | Standard Deviation | Newton-meter | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participant | Posted | Mean | Standard Deviation | Newton-meter | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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| 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. | participant | Posted | Mean | Standard Deviation | Newton-meter | Prior to each treatment session. Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke). |
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|
| 0 |
| 44 |
| 0 |
| 44 |
| 1 |
| 44 |
| EG001 | 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. | 0 | 39 | 0 | 39 | 2 | 39 |
| EG002 | Crossover-Phase 2 | Original Control Group receives 18 half-hour crossover treatments with the AMES device (Crossover) 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 each session one-half hour in length. AMES 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. | 0 | 27 | 0 | 27 | 1 | 27 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Site 3 |
|
| Site 4 |
|
| Site 5 |
|
| Site 6 |
|
| Effect Size |
| -0.29 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.40 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| -0.27 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.38 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.37 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.71 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.77 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.56 |
| 2-Sided |
| 95 |
| Superiority |
| Effect Size |
| 0.45 |
| 2-Sided |
| 95 |
| Superiority |