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The long-range goal of this work is to identify how to target treatment so that the brain is functionally re-organized to produce movement. This study will compare treatment response to robotics versus functional neuromuscular stimulation.
Methods. Up to ninety-six chronic stroke subjects (> 12 months post stroke) will be randomized to one of the treatment groups: Wrist/hand Functional Electrical Stimulation (FES)+whole arm motor learning group; shoulder/elbow robotics + whole arm motor learning group; and whole arm motor learning group. For all groups, treatment will offered 5 hrs/day, 5 days/week, for 12 weeks. All three treatment groups will receive motor learning therapy. For the Wrist/hand FES+whole arm motor learning group, there will be the addition of FES during treatment. For the Shoulder/elbow robotics + whole arm motor learning group there will be the addition of robotics training. Outcome measures will be collected at weeks 1, 6, 12, and three months after the end of treatment. Measures will include muscle strength (Manual Muscle Testing); coordination of joint movement (Fugl-Meyer Coordination Scale); motor control of target acquisition, pathway maintenance; and smoothness of movement (robotics measures); performance of 13 functional tasks (Arm Motor Ability Test); and quality of life (Stroke Impact Scale). Measures of brain function will be non-invasive and will include cognitive planning time, cognitive effort level, and location of brain activity during simple shoulder and arm movements. Changes in brain function measures will reflect plasticity or adaptability in response to treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wrist/Hand FES + Whole Arm Motor Learning | Experimental | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning training and FES of the wrist/hand. |
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| Shoulder/Elbow Robotics + Whole Arm Motor Learning | Experimental | Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics. |
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| Whole Arm Motor Learning | Experimental | Subjects>6 months following first stroke with diminished upper limb strength, coordination and function who received whole arm motor learning training without addition of FES or Robotics |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotics training for shoulder elbow. | Device | training utilizing a robot to assist with movement practice |
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| Measure | Description | Time Frame |
|---|---|---|
| AMAT | The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test. | prior to treatment and following 3 months of treatment |
| M1 Activation Absolute Change Score | A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659. | at baseline and following 3 months of treatment |
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Inclusion Criteria:
Exclusion Criteria:
uncontrolled, chronic medical condition
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| Name | Affiliation | Role |
|---|---|---|
| Janis Daly, PhD MS | VA Medical Center-Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17391704 | Background | Fang Y, Yue GH, Hrovat K, Sahgal V, Daly JJ. Abnormal cognitive planning and movement smoothness control for a complex shoulder/elbow motor task in stroke survivors. J Neurol Sci. 2007 May 15;256(1-2):21-9. doi: 10.1016/j.jns.2007.01.078. Epub 2007 Mar 27. | |
| 19362515 | Background | Fang Y, Daly JJ, Sun J, Hvorat K, Fredrickson E, Pundik S, Sahgal V, Yue GH. Functional corticomuscular connection during reaching is weakened following stroke. Clin Neurophysiol. 2009 May;120(5):994-1002. doi: 10.1016/j.clinph.2009.02.173. Epub 2009 Apr 10. |
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Subjects were recruited by word of mouth and from an advertisement flyer.
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| ID | Title | Description |
|---|---|---|
| FG000 | Wrist/Hand FES + Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES. |
| FG001 | Shoulder/Elbow Robotics + Whole Arm Motor Learning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Surface Functional Neuromuscular Stimulation | Device | training utilizing FNS to assist with movement practice |
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| whole arm motor learning | Other | intervention utilizing motor learning training principles to perform part and whole task practice of meaningful everyday functional tasks. |
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| 24613940 | Background | Daly JJ, Hrovat K, Holcomb J, Pundik S. Brain control of functional reach in healthy adults and stroke survivors. Restor Neurol Neurosci. 2014;32(5):559-73. doi: 10.3233/RNN-130361. |
| 21343527 | Background | Kisiel-Sajewicz K, Fang Y, Hrovat K, Yue GH, Siemionow V, Sun CK, Jaskolska A, Jaskolski A, Sahgal V, Daly JJ. Weakening of synergist muscle coupling during reaching movement in stroke patients. Neurorehabil Neural Repair. 2011 May;25(4):359-68. doi: 10.1177/1545968310388665. Epub 2011 Feb 22. |
| 21839177 | Background | Wang XF, Jiang Z, Daly JJ, Yue GH. A generalized regression model for region of interest analysis of fMRI data. Neuroimage. 2012 Jan 2;59(1):502-10. doi: 10.1016/j.neuroimage.2011.07.079. Epub 2011 Jul 31. |
| 18786565 | Background | Daly JJ, Hrovat K, Pundik S, Sunshine J, Yue G. fMRI methods for proximal upper limb joint motor testing and identification of undesired mirror movement after stroke. J Neurosci Methods. 2008 Oct 30;175(1):133-42. doi: 10.1016/j.jneumeth.2008.07.025. Epub 2008 Aug 22. |
| 28683745 | Derived | Philips GR, Daly JJ, Principe JC. Topographical measures of functional connectivity as biomarkers for post-stroke motor recovery. J Neuroeng Rehabil. 2017 Jul 6;14(1):67. doi: 10.1186/s12984-017-0277-3. |
Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics. |
| FG002 | Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Shoulder/Elbow Robotics + Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand. |
| BG001 | Wrist/Hand FES + Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow |
| BG002 | Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | AMAT | The AMAT is a measure of complex functional task performance of a variety of specified tasks and is measured in seconds summed across the various tasks. A higher score is indicative of decreased performance on the measure. A max score of 3000 seconds would indicate inability to perform any portion of the test. | Mean | Standard Deviation | seconds | prior to treatment and following 3 months of treatment |
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| Primary | M1 Activation Absolute Change Score | A measure of brain activation change in the area of M1 following intervention (pre to post intervention). A number greater than 0 indicates a change in brain activation in the area of M1. The maximum voxel activation for a healthy adult in the studied region of Interest (M1) is 659. | This is a sub sample of subjects eligible to undergo fMRI testing. A total of 23 subjects were eligible (5 subjects in the wrist/hand FES+ whole arm motor learning group; 8 subjects in the shoulder/elbow robotics+whole arm motor learning group and 10 subjects in the Whole arm motor learning group). | Mean | Standard Deviation | voxels | at baseline and following 3 months of treatment |
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Adverse event data were collected for the duration of study participation.
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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 | Wrist/Hand FES + Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.) | 0 | 11 | 0 | 11 | ||
| EG001 | Shoulder/Elbow Robotics + Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand. | 0 | 11 | 0 | 11 | ||
| EG002 | Whole Arm Motor Learning | Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand. | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center | Malcom Randall VA Medical Center, Gainesville Florida | (352) 376-1611 | 6603 | jjd17@case.edu |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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