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Sponsors and Collaborators: |
AMES Technology Oregon Health and Science University |
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Information provided by: | AMES Technology |
ClinicalTrials.gov Identifier: | NCT00600184 |
The AMES device a investigational device which cyclically rotates the ankle while muscle vibrators stimulate sensory receptors in the muscles opposite to the joint being rotated. In effect, the device provides assisted movement of a joint and enhanced sensation of that movement. The purpose of this study is to determine whether stroke survivors who remain unable to move normally more than one year after their stroke will be able to walk and move their affected leg significantly better after treatment with a new robotic therapy, the AMES device.
Condition | Intervention | Phase |
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Stroke Cerebrovascular Accident |
Device: The AMES device |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Clinic-Based Assisted Movement and Enhanced Sensation Treatment of Stroke |
Estimated Enrollment: | 16 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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One: Experimental |
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.
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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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda D. Cordo, BS MSN | 503-223-3442 | cordol@ohsu.edu |
United States, Oregon | |
Oregon Health and Science University Center for Health and Healing | Recruiting |
Portland, Oregon, United States, 97201 | |
Contact: Linda D. Cordo, BS MSN 503-223-3442 cordol@ohsu.edu | |
Contact: Paul J. Cordo, PhD 503-970-6129 cordop@ohsu.edu | |
Sub-Investigator: Helmi Lutsep, MD | |
Sub-Investigator: Connie Amos, MSCCC SLP | |
Sub-Investigator: Jennifer Wilhelm, DPT |
Principal Investigator: | Paul J. Cordo, PhD | AMES Technology Inc./ Oregon Health and Science University |
Responsible Party: | AMES Technology, Inc./ Oregon Health and Science University ( Paul J. Cordo/Principal Investigator ) |
Study ID Numbers: | CT002, IRB00004005 |
Study First Received: | December 31, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00600184 |
Health Authority: | United States: Institutional Review Board |
Stroke Rehabilitation Robotics |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Brain Ischemia |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |