The purpose of this study is to determine if individuals who had a stroke more than one year before entering the study and who remain unable to open their affected hand are better able to sense and move their affected arm after 10-15 weeks of treatment with a new robotic therapy device (the AMES device) and EMG biofeedback.
Over the last 20 years, the discovery of cortical plasticity in the adult human brain has led to the development of new therapies to rehabilitate stroke survivors whose recovery of motor function has stalled with conventional therapeutic methodology. However, the efficacy of these new therapies appears to be limited to relatively high-functioning chronic stroke patients. A therapeutic approach that may be efficacious in restoring functional movement to low-functioning chronic stroke patients is "AMES," which stands for Assisted Movement with Enhanced Sensation. Despite the efficacy of AMES in restoring movement to low-functioning hemiparetic stroke patients, those with plegia at a joint tend not to recover movement in the plegic direction with AMES treatment or with other rehabilitation therapies. The objective of this study is to determine if AMES treatment in combination with biofeedback can be helpful in restoring functional movement to plegic stroke patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.
Emory University School of Medicine
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Oregon Health and Science University
Portland, Oregon, United States
Box and Blocks Test
Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.
Time frame: Within a week of completing all training sessions.
Fugl-Meyer (UL) Assessment
Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.
Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions \[scored from 1 (least impact) to 5 (most impact)\]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed: \[(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range\] X 100. The minimum transformed score is 0 and the maximum is 100.
Time frame: Within a week of completing all training sessions.
Stroke Impact Scale (Stroke Recovery)
A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.
Time frame: Within a week of completing all training sessions.
Strength Test Flexion
Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
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Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
Strength Test Extension
Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.