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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 December 2012 |
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Main ID: |
NCT00600184 |
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Date of registration:
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31/12/2007 |
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Primary sponsor: |
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Public title:
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Clinic-Based AMES Treatment of Stroke
AMES |
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Scientific title:
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Clinic-Based Assisted Movement and Enhanced Sensation Treatment of Stroke |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00600184 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul J. Cordo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AMES Technology Inc./ Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 12 months post-stroke
- Cognitively and behaviorally capable of complying with the regimen
- Functioning proprioception
- Less than 50% of normal strength in the affected ankle, but able to stand with ot
without assistive devices
Exclusion Criteria:
- Fractures of treated limb resulting in loss of range of motion
- Spinal cord injury
- Deep vein thrombosis
- Peripheral nerve injury or neuropathy in the affected limb with motor disability
- Osteoarthritis limiting range of motion
- Skin condition not tolerant of device
- Progressive neurodegenerative disorder
- Uncontrolled seizure disorder
- Botox treatment within the last 5 months
- Baclofen pump
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebrovascular Accident
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Stroke
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Intervention(s)
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Device: The AMES device
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Primary Outcome(s)
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Fugl-Meyer Assessment of the Lower Extremity
[Time Frame: Pre-treatment, Post-treatment]
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Secondary Outcome(s)
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Biodex Isokinetic Strength Measurements
[Time Frame: Pre-treatment, Post-treatment]
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Gait Assessment
[Time Frame: Pre-treatment, Post-treatment]
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Joint Position Test
[Time Frame: Prior to each treatment session]
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Passive Motion Test
[Time Frame: Prior to each treatment session]
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Spasticity (Modified Ashworth) Scale
[Time Frame: Pre-treatment, Post-treatment]
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Strength Test
[Time Frame: Prior to each treatment session]
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Stroke Impact Scale
[Time Frame: Pre-treatment, Post-treatment]
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Secondary ID(s)
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CT002
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IRB00004005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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