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.
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.
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.
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.
Group
Value
95% CI
Test-Phase 1
0.0
± 2.1
Control-Phase 1
-0.6
± 2.9
Crossover-Phase 2
-0.6
± 2.0
Active Motion Test GraspSecondary· 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.
Group
Value
95% CI
Test-Phase 1
2.6
± 4.1
Control-Phase 1
1.5
± 4.4
Crossover-Phase 2
2.4
± 6.3
Active Motion WristSecondary· 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.
Group
Value
95% CI
Test-Phase 1
4.4
± 5.8
Control-Phase 1
2.7
± 4.4
Crossover-Phase 2
1.9
± 5.2
Strength Grasp FlexionSecondary· 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.
Group
Value
95% CI
Test-Phase 1
26.3
± 1.6
Control-Phase 1
24.6
± 1.7
Crossover-Phase 2
8.5
± 11.9
Strength Grasp ExtensionSecondary· 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.
Group
Value
95% CI
Test-Phase 1
4.2
± 0.6
Control-Phase 1
4.9
± 0.6
Crossover-Phase 2
4.3
± 7.6
Strength Wrist FlexionSecondary· 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.
Group
Value
95% CI
Test-Phase 1
53.8
± 2.6
Control-Phase 1
46.2
± 2.7
Crossover-Phase 2
16.2
± 21.1
Strength Wrist ExtensionSecondary· 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.
Group
Value
95% CI
Test-Phase 1
20.7
± 1.5
Control-Phase 1
18.3
± 1.6
Crossover-Phase 2
8.9
± 19.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Other recruiting trials for Cerebrovascular Stroke
Currently open trials in the same condition.
NCT06947343 — Effect of Action Observation Therapy in Comparison to Motor Relearning Program on Balance and Mobility Among Subacute St
· NA
· recruiting
NCT05028855 — Cerebral Autoregulation in Patients With Symptomatic Cerebral Atherosclerotic Stenosis
· recruiting
Other AMES Technology trials
Trials by the same sponsor.
NCT01116544 — Treatment of Chronic Stroke With AMES + EMG Biofeedback
· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AMES Technology
Last refreshed: 3 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00609115.