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Tracking Information | |||||
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First Received Date † | December 31, 2007 | ||||
Last Updated Date | December 10, 2008 | ||||
Start Date † | January 2008 | ||||
Current Primary Outcome Measures † |
Fugl-Meyer Assessment of the Lower Extremity [ Time Frame: Pre-treatment, Post-treatment ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00600184 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Clinic-Based AMES Treatment of Stroke | ||||
Official Title † | Clinic-Based Assisted Movement and Enhanced Sensation Treatment of Stroke | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † |
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Intervention † | Device: The AMES device | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 16 | ||||
Estimated Completion Date | June 2009 | ||||
Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00600184 | ||||
Responsible Party | Paul J. Cordo/Principal Investigator, AMES Technology, Inc./ Oregon Health and Science University | ||||
Secondary IDs †† | IRB00004005 | ||||
Study Sponsor † | AMES Technology | ||||
Collaborators †† | Oregon Health and Science University | ||||
Investigators † |
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Information Provided By | AMES Technology | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |