Trial Outcomes & Findings for Sub-Acute Stroke Rehabilitation With AMES (NCT NCT00609115)
NCT ID: NCT00609115
Last Updated: 2022-10-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).
Results posted on
2022-10-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Controlled Period
STARTED
|
44
|
39
|
0
|
|
Controlled Period
COMPLETED
|
38
|
35
|
0
|
|
Controlled Period
NOT COMPLETED
|
6
|
4
|
0
|
|
Crossover Period
STARTED
|
0
|
0
|
27
|
|
Crossover Period
COMPLETED
|
0
|
0
|
22
|
|
Crossover Period
NOT COMPLETED
|
0
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
Baseline characteristics by cohort
| Measure |
Test-Phase 1
n=44 Participants
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.
|
Control-Phase 1
n=39 Participants
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.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 12.7 • n=44 Participants
|
57.7 years
STANDARD_DEVIATION 12.9 • n=39 Participants
|
57.0 years
STANDARD_DEVIATION 12.8 • n=83 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=44 Participants
|
16 Participants
n=39 Participants
|
31 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=44 Participants
|
23 Participants
n=39 Participants
|
52 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=44 Participants
|
4 Participants
n=39 Participants
|
8 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=44 Participants
|
32 Participants
n=39 Participants
|
68 Participants
n=83 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=44 Participants
|
3 Participants
n=39 Participants
|
7 Participants
n=83 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=44 Participants
|
2 Participants
n=39 Participants
|
4 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=44 Participants
|
11 Participants
n=39 Participants
|
23 Participants
n=83 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=44 Participants
|
22 Participants
n=39 Participants
|
47 Participants
n=83 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=44 Participants
|
1 Participants
n=39 Participants
|
2 Participants
n=83 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=44 Participants
|
3 Participants
n=39 Participants
|
7 Participants
n=83 Participants
|
|
Stroke Type
Ischemic
|
37 Participants
n=44 Participants
|
34 Participants
n=39 Participants
|
71 Participants
n=83 Participants
|
|
Stroke Type
Hemorrhagic or Ischemic Plus Hemorrhagic
|
7 Participants
n=44 Participants
|
5 Participants
n=39 Participants
|
12 Participants
n=83 Participants
|
|
Study Site
Site 1
|
8 Participants
n=44 Participants
|
7 Participants
n=39 Participants
|
15 Participants
n=83 Participants
|
|
Study Site
Site 2
|
1 Participants
n=44 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=83 Participants
|
|
Study Site
Site 3
|
10 Participants
n=44 Participants
|
9 Participants
n=39 Participants
|
19 Participants
n=83 Participants
|
|
Study Site
Site 4
|
0 Participants
n=44 Participants
|
1 Participants
n=39 Participants
|
1 Participants
n=83 Participants
|
|
Study Site
Site 5
|
5 Participants
n=44 Participants
|
3 Participants
n=39 Participants
|
8 Participants
n=83 Participants
|
|
Study Site
Site 6
|
20 Participants
n=44 Participants
|
19 Participants
n=39 Participants
|
39 Participants
n=83 Participants
|
|
Time Since Stroke at Baseline
|
11.8 Weeks
STANDARD_DEVIATION 5.7 • n=44 Participants
|
11.3 Weeks
STANDARD_DEVIATION 5.0 • n=39 Participants
|
11.5 Weeks
STANDARD_DEVIATION 5.4 • n=83 Participants
|
|
Active Motion Test Grasp
|
9.8 Seconds
STANDARD_DEVIATION 4.9 • n=44 Participants • Two drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
|
10.0 Seconds
STANDARD_DEVIATION 6.7 • n=37 Participants • Two drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
|
9.9 Seconds
STANDARD_DEVIATION 5.5 • n=81 Participants • Two drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
|
|
Fugl-Meyer Assessment
|
20.9 units on a scale
STANDARD_DEVIATION 9.9 • n=44 Participants
|
23.7 units on a scale
STANDARD_DEVIATION 11.2 • n=39 Participants
|
22.5 units on a scale
STANDARD_DEVIATION 10.9 • n=83 Participants
|
|
Spasticity (Modified Ashworth) Scale
|
4.1 units on a scale
STANDARD_DEVIATION 3.0 • n=44 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 3.0 • n=39 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 3.0 • n=83 Participants
|
|
Strength Grasp Flexion
|
14.6 Newton meters
STANDARD_DEVIATION 14.3 • n=44 Participants • Two control group drop-out participants did not contribute baselines scores on this test.
|
16.4 Newton meters
STANDARD_DEVIATION 19.9 • n=37 Participants • Two control group drop-out participants did not contribute baselines scores on this test.
|
15.4 Newton meters
STANDARD_DEVIATION 16.8 • n=81 Participants • Two control group drop-out participants did not contribute baselines scores on this test.
|
|
Strength Wrist Flexion
|
31.7 Newton-meters
STANDARD_DEVIATION 27.4 • n=42 Participants • Two test group drop-out and one control group drop-out participants did not contribute baselines scores on this test.
|
36.5 Newton-meters
STANDARD_DEVIATION 39.4 • n=38 Participants • Two test group drop-out and one control group drop-out participants did not contribute baselines scores on this test.
|
33.9 Newton-meters
STANDARD_DEVIATION 33.0 • n=80 Participants • Two test group drop-out and one control group drop-out participants did not contribute baselines scores on this test.
|
|
Strength Grasp Extension
|
2.6 Newton-meters
STANDARD_DEVIATION 4.6 • n=44 Participants • Two control group drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
|
2.5 Newton-meters
STANDARD_DEVIATION 6.2 • n=37 Participants • Two control group drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
|
2.6 Newton-meters
STANDARD_DEVIATION 5.3 • n=81 Participants • Two control group drop-out participants did not attend the first 3 training sessions and, therefore, did not contribute baselines scores on this test.
|
|
Strength Wrist Extension
|
11.3 Newton-meters
STANDARD_DEVIATION 14.8 • n=43 Participants • One test group drop-out and two control group drop-out participants did not contribute baselines scores on this test.
|
10.5 Newton-meters
STANDARD_DEVIATION 14.6 • n=37 Participants • One test group drop-out and two control group drop-out participants did not contribute baselines scores on this test.
|
10.9 Newton-meters
STANDARD_DEVIATION 14.7 • n=80 Participants • One test group drop-out and two control group drop-out participants did not contribute baselines scores on this test.
|
|
Stroke Impact Scale
|
506.8 units on a scale
STANDARD_DEVIATION 80.9 • n=43 Participants • A site inadvertently omitted this test with one test group subject and one control group subject.
|
500.3 units on a scale
STANDARD_DEVIATION 92.9 • n=38 Participants • A site inadvertently omitted this test with one test group subject and one control group subject.
|
503.8 units on a scale
STANDARD_DEVIATION 86.5 • n=81 Participants • A site inadvertently omitted this test with one test group subject and one control group subject.
|
|
Rancho Los Amigos Functional Test
|
4.8 Number of tasks completed
STANDARD_DEVIATION 3.7 • n=44 Participants • A site inadvertently omitted this test on one control group participant.
|
5.9 Number of tasks completed
STANDARD_DEVIATION 4.5 • n=38 Participants • A site inadvertently omitted this test on one control group participant.
|
5.3 Number of tasks completed
STANDARD_DEVIATION 4.1 • n=82 Participants • A site inadvertently omitted this test on one control group participant.
|
|
Active Motion Wrist Test
|
17.6 Seconds
STANDARD_DEVIATION 10.7 • n=43 Participants • 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.
|
17.3 Seconds
STANDARD_DEVIATION 11.3 • n=37 Participants • 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.
|
17.4 Seconds
STANDARD_DEVIATION 10.0 • n=80 Participants • 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.
|
PRIMARY outcome
Timeframe: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).Population: Participants
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Fugl-Meyer Assessment Upper Limb Portion
|
10.8 units on a scale
Standard Deviation 7.4
|
6.4 units on a scale
Standard Deviation 7.7
|
4.7 units on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).Population: Participants
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Stroke Impact Scale
|
14.6 units on a scale
Standard Deviation 28.5
|
10.7 units on a scale
Standard Deviation 15.2
|
46.2 units on a scale
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).Population: participants
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Rancho Los Amigos Functional Test
|
3.5 units on a scale
Standard Deviation 4.3
|
2.1 units on a scale
Standard Deviation 3.4
|
-0.6 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Post-treatment-Phase 1 (month 3-6 post-stroke), post-crossover treatment-Phase 2 (month 5-7 post-stroke).Population: participants
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Spasticity (Modified Ashworth) Scale
|
0.0 units on a scale
Standard Deviation 2.1
|
-0.6 units on a scale
Standard Deviation 2.9
|
-0.6 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Active Motion Test Grasp
|
2.6 seconds
Standard Deviation 4.1
|
1.5 seconds
Standard Deviation 4.4
|
2.4 seconds
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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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Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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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|---|---|---|---|
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Active Motion Wrist
|
4.4 seconds
Standard Deviation 5.8
|
2.7 seconds
Standard Deviation 4.4
|
1.9 seconds
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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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|---|---|---|---|
|
Strength Grasp Flexion
|
26.3 Newton-meter
Standard Deviation 1.6
|
24.6 Newton-meter
Standard Deviation 1.7
|
8.5 Newton-meter
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Strength Grasp Extension
|
4.2 Newton-meter
Standard Deviation 0.6
|
4.9 Newton-meter
Standard Deviation 0.6
|
4.3 Newton-meter
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Strength Wrist Flexion
|
53.8 Newton-meter
Standard Deviation 2.6
|
46.2 Newton-meter
Standard Deviation 2.7
|
16.2 Newton-meter
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Test-Phase 1
n=38 Participants
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.
|
Control-Phase 1
n=35 Participants
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.
|
Crossover-Phase 2
n=22 Participants
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.
|
|---|---|---|---|
|
Strength Wrist Extension
|
20.7 Newton-meter
Standard Deviation 1.5
|
18.3 Newton-meter
Standard Deviation 1.6
|
8.9 Newton-meter
Standard Deviation 19.8
|
Adverse Events
Test-Phase 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control-Phase 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Crossover-Phase 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test-Phase 1
n=44 participants at risk
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.
|
Control-Phase 1
n=39 participants at risk
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.
|
Crossover-Phase 2
n=27 participants at risk
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.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin abrasion from vibrator probe
|
2.3%
1/44 • Number of events 1 • 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.
|
5.1%
2/39 • Number of events 2 • 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.
|
3.7%
1/27 • Number of events 1 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place