This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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.
Oregon Health and Science University
Portland, Oregon, United States
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.
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
Timed 10-Meter Walk
Gait Assessment - Time
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
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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.
Time frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)