Cerebrovascular Accident, Paresis, Plegia, Stroke
Conditions
Keywords
AMES device, Cerebrovascular Accident, Chronic Stroke, Rehabilitation, Upper Extremity, Biofeedback
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAMES Therapy (assisted movement and enhanced sensation)
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.
Sponsors
Oregon Health and Science University
Emory University
Northwestern University
AMES Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Hemispheric stroke (ischemic or hemorrhagic), cortical or sub-cortical, documented by either a CT or MRI scan and associated with residual upper extremity weakness. * Chronic stroke, occurring ≥12 months prior to subject enrollment. * Age 18-80 years old. * Inability to move any of the fingers of the affected hand more than 5.0 cm into extension. * Finger-and-wrist impedance ≤3 on the Modified Ashworth Scale. * Measureable EMG (\>2 x baseline) in the long finger extensor muscle during attempted hand opening or closing. * Physically and cognitively capable of consenting to and complying with the protocol (based on exam by Study Physician). * Subject must be physically capable of communicating informed consent or must be accompanied by legally authorized representative to provide informed consent.
Exclusion criteria
* Complete flaccidity of the affected arm. * Significant upper extremity proprioceptive deficit (\<70% correct detection of the direction of passive finger movement with eyes closed). * Pathological neurological/physical conditions, other than stroke, impairing the function of the impaired arm or resulting in pain in the arm. * Spinal cord injury, arthritis, or fractures of affected arm that have resulted in loss of range of motion. * Peripheral nerve injury or neuropathy resulting in significant motor or sensory loss in the tested arm. * Cardiopulmonary compromise including but not limited to uncontrolled hypertension or angina, deep vein thrombosis, decompensated congestive heart failure, myocardial infarction, heart irregularities, or exercise intolerance. * Major active psychiatric disorder. * Cognitively or behaviorally unable to follow instructions including severe apraxia; inability to understand verbal (English) directions, or inability to communicate adequately with study personnel. * Size of arm incompatible with the AMES device (checked by placing the limb in the device). * Severe contractures or decreased range of motion or skin condition that would prohibit comfortable positioning or tolerance of the device or the vibrators. * Any progressive neurodegenerative disorder affecting the upper extremity motor system. * Uncontrolled seizure disorder. * Current abuse of alcohol or drugs. * Terminal illness with anticipated survival of \<12 months. * Current or planned concurrent participation in another study involving therapy to the impaired arm * Planned initiation of or cessation of any kind of clinical therapy to the impaired limb just prior to or during the AMES treatment period. * NIH Stroke Scale, following scores: Sensory Item score of \>1; Neglect involving the affected limb score \>1. * Intent to receive Botox injections (5 months prior to or during enrollment), initiation of antispasmodic medication, or use of any other robotic (e.g., MANUS, Locomat) or electrical or vibratory stimulation device (e.g., Bioness) while participating in the AMES trial. * Cognitively or behaviorally unable to follow instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Blocks Test | Within a week of completing all training sessions. | Measurement of the change in functional movement of the hand associated with 30 AMES training sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke Impact Scale (Stroke Recovery) | Within a week of completing all training sessions. | 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. |
| Fugl-Meyer (UL) Assessment | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. | 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. |
| Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) | Within a week of completing all training sessions. | 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. |
| Strength Test Flexion | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. | 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. |
| Strength Test Extension | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMES Therapy With EMG Biofeedback The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. 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. | 21 |
| AMES Therapy With Torque Biofeedback The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. 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. | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | AMES Therapy With EMG Biofeedback | AMES Therapy With Torque Biofeedback | Total |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 13 | 45 years STANDARD_DEVIATION 15 | 46 years STANDARD_DEVIATION 14 |
| Box-and-Block Test | 0.0 Blocks moved | 0.0 Blocks moved | 0.0 Blocks moved |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Fugl-Meyer Assessment-Upper Limb | 19.4 units on a scale STANDARD_DEVIATION 6.2 | 23.1 units on a scale STANDARD_DEVIATION 8.8 | 21.3 units on a scale STANDARD_DEVIATION 7.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 10 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
| Strength Test Extension | -4.4 Newton-meters | 0.4 Newton-meters | -0.9 Newton-meters |
| Strength Test Flexion | 16.6 Newton-meters | 18.0 Newton-meters | 17.6 Newton-meters |
| Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) | 51.0 units on a scale STANDARD_DEVIATION 9.1 | 53.6 units on a scale STANDARD_DEVIATION 17 | 52.3 units on a scale STANDARD_DEVIATION 9.1 |
| Stroke Impact Scale (Stroke Recovery) | 44.0 units on a scale STANDARD_DEVIATION 23.3 | 48.0 units on a scale STANDARD_DEVIATION 23.3 | 46.0 units on a scale STANDARD_DEVIATION 23.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 23 | 8 / 23 |
| serious Total, serious adverse events | 3 / 23 | 0 / 23 |
Outcome results
Primary
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.
Population: Chronic stroke with severe hand impairment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AMES Therapy With EMG Biofeedback | Box and Blocks Test | 0.0 Number of blocks moved |
| AMES Therapy With Torque Biofeedback | Box and Blocks Test | 0.5 Number of blocks moved |
p-value: <0.005Wilcoxon (Mann-Whitney)
Secondary
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.
Population: Chronic stroke with severe upper limb impairment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AMES Therapy With EMG Biofeedback | Fugl-Meyer (UL) Assessment | 23.7 units on a scale | Standard Deviation 6.2 |
| AMES Therapy With Torque Biofeedback | Fugl-Meyer (UL) Assessment | 27.0 units on a scale | Standard Deviation 10.3 |
p-value: <0.001ANCOVA
Secondary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AMES Therapy With EMG Biofeedback | Strength Test Extension | -11.4 Newton-meters |
| AMES Therapy With Torque Biofeedback | Strength Test Extension | 0.6 Newton-meters |
Comparison: Both treatment groups combinedp-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AMES Therapy With EMG Biofeedback | Strength Test Flexion | 21.2 Newton-meters |
| AMES Therapy With Torque Biofeedback | Strength Test Flexion | 30.8 Newton-meters |
Comparison: Data combined between 2 treatment groupsp-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AMES Therapy With EMG Biofeedback | Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) | 54.0 units on a scale | Standard Deviation 8.1 |
| AMES Therapy With Torque Biofeedback | Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL) | 57.4 units on a scale | Standard Deviation 18 |
p-value: 0.001ANCOVA
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AMES Therapy With EMG Biofeedback | Stroke Impact Scale (Stroke Recovery) | 58.3 units on a scale | Standard Deviation 18.2 |
| AMES Therapy With Torque Biofeedback | Stroke Impact Scale (Stroke Recovery) | 63.3 units on a scale | Standard Deviation 17.3 |
p-value: 0.001ANCOVA