Sub-Acute Stroke Rehabilitation With AMES

Completed · Not applicable · Has a placebo group

Conditions studied: Cerebrovascular Stroke

In brief

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.

Key facts

Study ID

NCT00609115

Run by

AMES Technology

People needed

83

Starts

2007-09-01

Expected to finish

2011-02-28

Last updated by the study team

2022-10-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <19 out of 63 on the 21-question version of the Beck Depression Inventory.
• Subject or legally authorized representative must be capable of providing informed consent.-

You may not qualify if…

• Complete flaccidity of the hand, wrist, and ankle.
• Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or leg or resulting in pain in either the arm or leg.
• Spinal cord injury, arthritis, or fractures of affected limbs that have resulted in loss of range of motion.
• Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the limb being considered for testing.
• Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance.
• Major active psychiatric disorder.
• Severe apraxia; inability to understand verbal (English) directions; or inability to communicate adequately with study personnel.
• Size of arm or leg incompatible with the AMES device.
• Severe contractures or decreased range of motion that would prohibit comfortable positioning or tolerance of the device
• Skin condition not able to tolerate use of the AMES device.
• Any progressive neurodegenerative disorder affecting the motor system.
• Uncontrolled seizure disorder.
• Current abuse of alcohol or drugs.
• Terminal illness with anticipated survival of <12 months.
• Current or planned concurrent participation in another study or clinical trial.
• NIH Stroke Scale, following scores: Item 1a > 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.

Where it is running

• Eisenhower Medical Center — Rancho Mirage, California, United States
• UCSF School of Medicine- Physical Therapy and Rehabilitation — San Francisco, California, United States
• Emory University Dept of Rehabilitation Medicine/School of Medicine — Atlanta, Georgia, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• NW Medical Rehabilitation — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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