N/A
Completed N=83
Sub-Acute Stroke Rehabilitation With AMES
Cerebrovascular Stroke
Source: ClinicalTrials.gov NCT00609115 ↗
Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Fugl-Meyer Assessment Upper Limb Portion — 10.8; 6.4; 4.7 units on a scale — p=0.010
Summary
The AMES device is designed to produce functional cortical changes by:(1) assisting the subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement sensation by vibrating the muscles during movement (enhanced sensation). The primary hypothesis is that the combination of assisted movement and enhanced sensation from muscle vibration can increase the amount of motor recovery in individuals disabled by a stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Assessment Upper Limb Portion |
10.8; 6.4; 4.7 | 0.010 sig |
| SECONDARY Stroke Impact Scale |
14.6; 10.7; 46.2 | 1.00 |
| SECONDARY Rancho Los Amigos Functional Test |
3.5; 2.1; -0.6 | 0.17 |
| SECONDARY Spasticity (Modified Ashworth) Scale |
0.0; -0.6; -0.6 | 0.83 |
| SECONDARY Active Motion Test Grasp |
2.6; 1.5; 2.4 | 0.28 |
| SECONDARY Active Motion Wrist |
4.4; 2.7; 1.9 | 0.18 |
| SECONDARY Strength Grasp Flexion |
26.3; 24.6; 8.5 | 0.45 |
| SECONDARY Strength Grasp Extension |
4.2; 4.9; 4.3 | 0.47 |
| SECONDARY Strength Wrist Flexion |
53.8; 46.2; 16.2 | 0.05 |
| SECONDARY Strength Wrist Extension |
20.7; 18.3; 8.9 | 0.27 |
Eligibility Criteria
Inclusion Criteria
- Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual weakness in the arm and/or leg.
- First time ever stroke or previous stroke with complete resolution of motor deficit, occurring ≤4 months prior to subject enrollment.
- Age 18-80 years old.
- Moderate to severe lower-extremity paresis (defined as a leg motor Fugl-Meyer score of ≥6 and ≤22 out of a possible 34.
- Moderate to severe upper-extremity paresis (defined as an arm motor Fugl-Meyer score of ≥6 and ≤43 out of a possible 66.
- Visible voluntary movement of the ankle in at least one direction: dorsiflexion or plantarflexion for the ankle and flexion or extension for the hand.
- At least partially functioning proprioception from the paretic arm or leg-capable of correctly identifying, ≥70% of the time, the direction of passive joint rotation (i.e., flexion-extension) with eyes closed.
- Physically and cognitively capable of consenting to and complying with the protocol.
- Score of 0; Item 1c > 0; Item 2 > 0; Item 3 > 0; Item 9 > 2; Item 10 > 1; Item 11 > 1 (based on exam by Study Physician).
- Intent to receive Botox injections, initiation of antispasmodic medication, or use any other robotic (e.g., MANUS, Locomat) or stimulation device (e.g., Bioness) while participating in the AMES trial.
Data sourced from ClinicalTrials.gov (NCT00609115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.