Clinic-Based AMES Treatment of Stroke

Study Overview
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Brief Summary
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This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.

Detailed Description
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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.

Official Title
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Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects

Conditions
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Stroke, Cerebrovascular Accident

Intervention / Treatment
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* Device: Assisted movement and enhanced sensation


Participation Criteria
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Eligibility 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test treatment group<br>Device: Assisted movement and enhanced sensation | Device: Assisted movement and enhanced sensation<br>* Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment of the Lower Extremity | Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score. | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed 10-Meter Walk | Gait Assessment - Time | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | 
| Stroke Impact Scale | The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows: Transformed Scale=[(Actual raw score-lowest possible raw score)/Possible raw score range]x100. Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning. | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | 
| Spasticity (Modified Ashworth) Scale | Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone. | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | 
| Strength Test | Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions). | First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) | 
| Active Motion Test | Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen. | First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, Robotics