N/A
N=46
Treatment of Chronic Stroke With AMES + EMG Biofeedback
Stroke · Plegia · Paresis · Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT01116544 ↗Enrolled (actual)
46
Serious AEs
6.5%
Results posted
Nov 2019
Primary outcome: Primary: Box and Blocks Test — 0.0; 0.5 Number of blocks moved — p=<0.005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AMES Therapy (assisted movement and enhanced sensation) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AMES Technology
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Box and Blocks Test |
0.0; 0.5 | <0.005 sig |
| SECONDARY Fugl-Meyer (UL) Assessment |
23.7; 27.0 | <0.001 sig |
| SECONDARY Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) |
54.0; 57.4 | 0.001 sig |
| SECONDARY Stroke Impact Scale (Stroke Recovery) |
58.3; 63.3 | 0.001 sig |
| SECONDARY Strength Test Flexion |
21.2; 30.8 | 0.001 sig |
| SECONDARY Strength Test Extension |
-11.4; 0.6 | >0.05 |
Summary
The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.
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 upper extremity weakness.
- Chronic stroke, occurring ≥12 months prior to subject enrollment.
- Age 18-80 years old.
- Inability to move any of the fingers of the affected hand more than 5.0 cm into extension.
- Finger-and-wrist impedance ≤3 on the Modified Ashworth Scale.
- Measureable EMG (>2 x baseline) in the long finger extensor muscle during attempted hand opening or closing.
- Physically and cognitively capable of consenting to and complying with the protocol (based on exam by Study Physician).
- Subject must be physically capable of communicating informed consent or must be accompanied by legally authorized representative to provide informed consent.
Exclusion Criteria
- Complete flaccidity of the affected arm.
- Significant upper extremity proprioceptive deficit ( 1; Neglect involving the affected limb score >1.
- Intent to receive Botox injections (5 months prior to or during enrollment), initiation of antispasmodic medication, or use of any other robotic (e.g., MANUS, Locomat) or electrical or vibratory stimulation device (e.g., Bioness) while participating in the AMES trial.
- Cognitively or behaviorally unable to follow instructions
Data sourced from ClinicalTrials.gov (NCT01116544). 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.