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Funding not available.
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| Name | Class |
|---|---|
| AMES Technology | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test treatment group | Experimental | Device: Assisted movement and enhanced sensation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assisted movement and enhanced sensation | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul J. Cordo, PhD | AMES Technology Inc./Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18645190 | Background | Cordo P, Lutsep H, Cordo L, Wright WG, Cacciatore T, Skoss R. Assisted movement with enhanced sensation (AMES): coupling motor and sensory to remediate motor deficits in chronic stroke patients. Neurorehabil Neural Repair. 2009 Jan;23(1):67-77. doi: 10.1177/1545968308317437. Epub 2008 Jul 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Group | Device: Assisted movement and enhanced sensation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Stroke >1 yr prior to enrollment Able to stand independently <50% normal strength in affected leg Functioning proprioception in affected leg
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Group | Device: Assisted movement and enhanced sensation Assisted movement and enhanced sensation: 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. Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments. |
| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up |
|
|
1 year, 1 month
Verbal inquiry at the beginning of each training session.
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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 | Test Treatment Group | Device: Subjects receiving AMES treatments. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Loss of balance during moving |
Early termination due to lack of funding lead to only 2 subjects treated and analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul J. Cordo | Oregon Health & Science University | 503-418-2520 | cordop@ohsu.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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) |
| years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Time since stroke | Mean | Standard Deviation | Months |
|
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| Secondary | Timed 10-Meter Walk | Gait Assessment - Time | Posted | Mean | Standard Deviation | seconds | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up |
|
|
|
| Secondary | Strength Test | Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions). | Posted | Mean | Standard Deviation | Newton meters | First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Seconds | First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) |
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| 0 |
| 3 |
| 1 |
| 3 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
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| Title |
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| Measurements |
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