AMES Treatment of the Impaired Leg in Chronic Stroke Patients
NCT ID: NCT01378637
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2011-01-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMES Leg treatment
An investigational device flexes and extends the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the foot. The subject's task is to assist the motion of the device by pulling or pushing with the foot. Feedback of ankle torque or the electrical signal produced by the muscles (EMG) while the subject is assisting the motion is provided during the 30 treatment sessions.
AMES- Leg treatment
30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible.
Interventions
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AMES- Leg treatment
30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible.
Eligibility Criteria
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Inclusion Criteria
* At least 12 months post-stroke
* Can comfortably fit foot in treatment device
* Functioning proprioception
* Fugl-Meyer LE score \>6 and \<23
* Minimal hemi-neglect
* Observable volitional movement of the ankle in either plantar- or dorsi-flexion
* Cognitively and behaviorally capable of complying with the regimen
Exclusion Criteria
* Spinal cord injury
* Deep venous thrombosis
* Peripheral nerve injury or neuropathy in the affected limb with motor disability
* Osteoarthritis limiting range of motion
* Uncontrolled high blood pressure/angina
* Exercise intolerant
* Skin condition not tolerant of device
* Progressive neurodegenerative disorder
* Uncontrolled seizure disorder
* Botox treatment within last 5 months
* Baclofen pump
18 Years
85 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Northwestern University
OTHER
Shirley Ryan AbilityLab
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
AMES Technology
INDUSTRY
Responsible Party
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Principal Investigators
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Barry Oken, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Elliot Roth, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University/Rehabilitation Institute of Chicago
Locations
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Northwestern University/Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Oregon Health and Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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7034
Identifier Type: -
Identifier Source: org_study_id