Clinic-Based AMES Treatment of Stroke
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.
Full description
The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.
Enrollment
Sex
Ages
Volunteers
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 or 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 limb affected 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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