Stroke Clinical Trial
— AMESOfficial title:
AMES Treatment of the Impaired Leg in Chronic Stroke Patients
Verified date | December 2016 |
Source | AMES Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this protocol is to determine if individuals who had a stroke more than one year before entering the study and whose ankles remain substantially impaired are able to sense and move the affected leg better after 9-13 weeks of treatment with a robotic therapy device (AMES).
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | July 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Spastic hemiparesis - 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: - Fractures of treated limb resulting in loss of range of motion - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University/Rehabilitation Institute of Chicago | Chicago | Illinois |
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
AMES Technology | National Institute of Neurological Disorders and Stroke (NINDS), Northwestern University, Oregon Health and Science University, Rehabilitation Institute of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fugl-Meyer Motor Assessment of the Lower Affected Extremity | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | No | |
Secondary | Gait Assessment | The gait assessment will consist of the timed 10-Meter walk and the Tinetti Gait Test. | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | No |
Secondary | Modified Ashworth Scale | Measurement of spasticity in the ankle joint. | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | No |
Secondary | Dynamic Balance/Weight Distribution | Measure the subject's right-left weight distribution and dynamic balance control. | Measured three times: 1) Baseline; 2) After 30 Treatments (typically 10-13 weeks); and 3) Three Months after completing Treatments | No |
Secondary | Ankle Strength | Measurement of three attempts of dorsiflexion and three attempts of plantarflexion. | Prior to each treatment session, | No |
Secondary | Passive Motion Test | Measures the peak resistance in the affected ankle. | Prior to each treatment session | No |
Secondary | Active Range of Motion Test | A joint tracking task guided by visual feedback on a computer screen. | Prior to each treatment session | No |
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