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Sponsors and Collaborators: |
AMES Technology NW Medical Rehabilitation Emory University University of California, San Francisco Rehabilitation Institute of Chicago |
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Information provided by: | AMES Technology |
ClinicalTrials.gov Identifier: | NCT00609115 |
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.
Condition | Intervention | Phase |
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Cerebrovascular Stroke |
Device: AMES device Device: AMES device (sham) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Sub-Acute Stroke Rehabilitation With Assisted Movement With Enhanced Sensation |
Estimated Enrollment: | 132 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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T: Experimental
The Test Group will have 18 half hour AMES (Assisted Movement with Enhanced Sensation) treatments per qualified subject limb with the AMES device. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
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Device: AMES device
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
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C-1: Sham Comparator
Eighteen treatment sessions for each qualifying subject limb using the AMES device programed to provide placebo therapy. Each treatment session consisting of 30 minutes of placebo therapy. Sessions to be scheduled preferably 2 to 3 times per week, with the 18 sessions to be completed within the 6 month anniversary date of the subject's stroke.
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Device: AMES device (sham)
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session to provide thirty minutes of the placebo form of AMES therapy.
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C-2: Active Comparator
Crossover treatment of subjects who received placebo treatment during Phase 1 of the study to provide 18 regular (i.e., non-placebo) AMES (Assisted Movement with Enhanced Sensation) treatment sessions. Sessions to be scheduled preferably 2 to 3 times per week with each session one-half hour in length.
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Device: AMES device
Eighteen treatment sessions for each qualifying subject limb using the AMES device. Each treatment session being 30 minutes long. Sessions to be scheduled preferable 2 to 3 times per week, with the 18 sessions to be completed as soon as possible after the completion of Arm C-1 Sham Comparator.
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Approximately 700,000 U.S. citizens have a stroke each year with about half ending up with significant motor disabilities. There are an estimated 5 million stroke survivors in the U.S., making strokes the leading cause of long-term disability in the U.S.. Existing rehabilitation therapies have not been effective in returning all stroke survivors to full motor recovery.
The AMES device was designed to be able to provide therapy for the ankle joint and the hand (fingers/wrist). Subjects may qualify for one or two limbs. In this 18 treatment sessions, double-blinded, control study, AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following a stroke. Those control subject who complete the Phase 1 placebo sessions will have the opportunity to cross-over to participate in a AMES treatment group for a Phase 2.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSF School of Medicine- Physical Therapy and Rehabilitation | Recruiting |
San Francisco, California, United States, 94123 | |
Contact: Kelly Westlake, PT, MSc, PhD 415-476-4124 westlake@radmail.radiology.ucsf.edu | |
Principal Investigator: Nancy Byl, Ph.D. | |
United States, Georgia | |
Emory University Dept. of Rehabilitation Medicine/School of Medicine | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Aimee Reiss, MPT 404-712-8685 aimee.reiss@emory.edu | |
Contact: Kelly Crabtree, PT 404-712-4000 kcrabtr@emory.edu | |
Principal Investigator: Steven L Wolf, Ph.D. | |
United States, Illinois | |
Northwestern University, Rehabilitation Institute of Chicago | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Cathy Manno, MS CCRC 312-238-1427 cmanno@northwestern.edu | |
Principal Investigator: William Z Rymer, MD Ph.D. | |
United States, Washington | |
NW Medical Rehabilitation | Recruiting |
Spokane, Washington, United States, 99202 | |
Contact: Maureen Elston 509-869-6403 melston@gonzaga.edu | |
Contact: Beverly Kelley 509-624-0908 ext 210 mroot@nwmedicalrehab.com | |
Principal Investigator: Karen Stanek, MD |
Study Director: | Paul J. Cordo, PhD | AMES Technology Inc./ Oregon Health and Science University |
Responsible Party: | AMES Technology, Inc. ( Paul J. Cordo/Study Director ) |
Study ID Numbers: | CT001 |
Study First Received: | December 27, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00609115 |
Health Authority: | United States: Institutional Review Board |
Sub-acute care Robotics |
Cerebral Infarction Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |