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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
| Emory University | OTHER |
| Northwestern University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMES therapy with EMG biofeedback | Experimental | 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. This study will examine whether AMES therapy combined with EMG biofeedback can restore hand opening to plegic stroke subjects. |
|
| AMES therapy with Torque biofeedback | Experimental | 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 torque (force) the subject is able to generate in the hand during the movement. This study will examine whether AMES therapy combined with Torque biofeedback can restore hand opening to plegic stroke subjects. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMES Therapy (assisted movement and enhanced sensation) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Blocks Test | Measurement of the change in functional movement of the hand associated with 30 AMES training sessions. | Within a week of completing all training sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J. Cordo, PhD | Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24232364 | Derived | Cordo P, Wolf S, Lou JS, Bogey R, Stevenson M, Hayes J, Roth E. Treatment of severe hand impairment following stroke by combining assisted movement, muscle vibration, and biofeedback. J Neurol Phys Ther. 2013 Dec;37(4):194-203. doi: 10.1097/NPT.0000000000000023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Stroke ≥1 year post-injury with severe limitation of finger extension, but with intact upper limb proprioception.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Box and Blocks Test | Measurement of the change in functional movement of the hand associated with 30 AMES training sessions. | Chronic stroke with severe hand impairment | Posted | Median | Inter-Quartile Range | Number of blocks moved | Within a week of completing all training sessions. |
|
2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Fall not related to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Cordo | Oregon Health & Science University | 503 418 2520 | cordop@ohsu.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010243 | Paralysis |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| 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. | 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. | 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. | 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. | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fugl-Meyer Assessment-Upper Limb | Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score includes only the upper extremity portion of the Motor Function subscale of the assessment, that 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. | Mean | Standard Deviation | units on a scale |
|
| Strength Test Flexion | Based on average strength in first 3 training sessions. | Median | Inter-Quartile Range | Newton-meters |
|
| Strength Test Extension | Median | Inter-Quartile Range | Newton-meters |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Box-and-Block Test | Measure of functional movement | Median | Inter-Quartile Range | Blocks moved |
|
| OG001 | 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. |
|
|
|
| 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. | Chronic stroke with severe upper limb impairment | Posted | Mean | Standard Deviation | units on a scale | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Within a week of completing all training sessions. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Within a week of completing all training sessions. |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Newton-meters | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. |
|
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|
|
| 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. | Posted | Median | Inter-Quartile Range | Newton-meters | At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks. |
|
|
|
|
| 3 |
| 23 |
| 6 |
| 23 |
| EG001 | 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. | 0 | 23 | 8 | 23 |
|
| Scratched cornea | Eye disorders | Systematic Assessment | From contact lens, not related to study |
|
| Flu-like symptoms, high blood pressure | Cardiac disorders | Systematic Assessment | Treated at hospital, not related to study |
|
| Seizure | Nervous system disorders | Systematic Assessment |
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| Skin abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | From vibrator |
|
| Muscle soreness/fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hand pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |