Clinic-Based AMES Treatment of Stroke (AMES)
Device: The AMES device
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clinic-Based Assisted Movement and Enhanced Sensation Treatment of Stroke|
- Fugl-Meyer Assessment of the Lower Extremity [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
- Gait Assessment [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
- Stroke Impact Scale [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
- Spasticity (Modified Ashworth) Scale [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
- Biodex Isokinetic Strength Measurements [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ]
- Strength Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
- Joint Position Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
- Passive Motion Test [ Time Frame: Prior to each treatment session ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||February 2013|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Device: The AMES device
The AMES device is a investigational device which cyclically rotates the ankle while muscle vibrators stimulate sensory receptors in the muscles opposite to the joint being rotated. Each subject will be tested before and after the 10-week treatment period. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.
Each year, more that 600,000 U.S. citizens survive a major stroke. Following acute treatment, 30-40% of these survivors sustain permanent motor disabilities. Within weeks of the stroke, surviving patients begin physical therapy to restore motion to affected limbs. Some recover completely, but many do not. There are over 5 million stroke survivors in the U.S. who did not recover completely and many are severely incapacitated for the remainder of their lives.
The hypothesis underlying stroke rehabilitation with AMES is that, in many stroke victims, the damage to the brain disrupts one or more feedback loops that connect the proprioceptive receiving areas of the primary somatosensory cortex to the primary and pre-motor cortex. Without proprioceptive information feeding into the motor output center, the brain cannot "locate" the muscles needed for movement to occur. The hypothesis behind AMES rehabilitation is that synchronous and repetitive activity of the input and output areas of the cortex stimulate the reorganization of brain pathways, thereby closing the feedback loop disrupted by the stroke.
Our research objective is to develop procedures to rehabilitate those stroke patients who, through conventional therapies, were not brought to a level of maximal recovery. The aim of the study is to obtain a set of data from a total of 16 chronic stroke subjects, all with lower extremity disability, between the ages of 18-75, using the AMES robotic device in a rehabilitation clinic. Each subject will participate in 10 weeks of therapy, 3 days per week, 30 minutes per day. The data collected will be analysed to quantify the extent to which a combination of robot-assisted exercise and muscle vibration induce secondary recovery from stroke in the lower extremity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600184
|United States, Oregon|
|Oregon Health and Science University Center for Health and Healing|
|Portland, Oregon, United States, 97201|
|Principal Investigator:||Paul J. Cordo, PhD||AMES Technology Inc./ Oregon Health and Science University|