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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
| National Institutes of Health (NIH) | NIH |
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Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.
Loss of hand function is common after stroke. Previous research suggests that treatments that focus on movement of both hands at the same time or treatments that electrically stimulate the paretic (weak) hand muscles may help the recovery of hand function after stroke. In this study, two electrical stimulation treatments will be compared in their effectiveness in restoring hand movement and hand function. One of the treatments is stimulation only, and the other is stimulation linked to movement of the contralateral hand.
Study participants will be stroke survivors who are enrolled while they are still within their first 6 months after their stroke. After enrolling, their hand movement and function will be tested. Then they will be randomly assigned to one of the two treatments. Each treatment will last 6 weeks. The treatment will require the participant to perform specific exercises at home for a total of 2 hours every day and to come to the laboratory twice a week for study-related occupational therapy. At the end of the 6-week treatment, tests of hand movement and hand function will be repeated. The same tests will be repeated again at 1 and 3 months after the end of treatment to see if the effects of the treatment persist as time goes on. Changes in upper extremity impairment and activity limitation will be compared across treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCFES | Experimental | CCFES - Contralaterally Controlled Functional Electrical Stimulation
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| cNMES | Active Comparator | cNMES - Cyclic NeuroMuscular Electrical Stimulation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulator | Device | Intervention Characteristics Common to Both Groups • 6-week intervention
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment) | A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger. | 3 months post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Finger Tracking Error | A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayme S Knutson, PhD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17398254 | Background | Knutson JS, Harley MY, Hisel TZ, Chae J. Improving hand function in stroke survivors: a pilot study of contralaterally controlled functional electric stimulation in chronic hemiplegia. Arch Phys Med Rehabil. 2007 Apr;88(4):513-20. doi: 10.1016/j.apmr.2007.01.003. | |
| 8831470 | Background | Glanz M, Klawansky S, Stason W, Berkey C, Chalmers TC. Functional electrostimulation in poststroke rehabilitation: a meta-analysis of the randomized controlled trials. Arch Phys Med Rehabil. 1996 Jun;77(6):549-53. doi: 10.1016/s0003-9993(96)90293-2. |
| Label | URL |
|---|---|
| Cleveland FES Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CCFES | CCFES - Contralaterally Controlled Functional Electrical Stimulation
|
| FG001 | cNMES | cNMES - Cyclic NeuroMuscular Electrical Stimulation.
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CCFES | CCFES - Contralaterally Controlled Functional Electrical Stimulation
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment) | A custom-built electrogoniometer recorded the angles of the metacarpophalangeal (MP) and proximal interphalangeal (PIP) joints of the index finger simultaneously. Participants were seated with the forearm and wrist supported and stabilized in a neutral posture. From this resting postion, they were instructed to extend their fingers as fully as possible in response to a 4-sec audio cue. The MP and PIP angles were added together, providing a composite measure of degree of finger extension, where 0 degrees corresponds to full extension of the MP and PIP joints. The more negative the angle, the more flexed the finger. | The participants who completed the 6-week treatment phase were included in the analysis. | Posted | Mean | Standard Error | degrees | 3 months post-treatment. |
|
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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 | CCFES | CCFES - Contralaterally Controlled Functional Electrical Stimulation
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayme Knutson | MetroHealth Medical Center | 216-778-8364 | jsk12@case.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 3 months post-treatment. |
| Box and Blocks Score | The number of blocks picked up and moved across a barrier in 60 seconds | 3 months post-treatment. |
| Arm Motor Abilities Test | The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5. | 3 months post-treatment. |
| Fugl-Meyer Assessment (Upper Extremity) | The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better). | 3 months post-treatment. |
| 9596245 | Background | Chae J, Bethoux F, Bohine T, Dobos L, Davis T, Friedl A. Neuromuscular stimulation for upper extremity motor and functional recovery in acute hemiplegia. Stroke. 1998 May;29(5):975-9. doi: 10.1161/01.str.29.5.975. |
| 15494583 | Background | Luft AR, McCombe-Waller S, Whitall J, Forrester LW, Macko R, Sorkin JD, Schulz JB, Goldberg AP, Hanley DF. Repetitive bilateral arm training and motor cortex activation in chronic stroke: a randomized controlled trial. JAMA. 2004 Oct 20;292(15):1853-61. doi: 10.1001/jama.292.15.1853. |
| 11022069 | Background | Whitall J, McCombe Waller S, Silver KH, Macko RF. Repetitive bilateral arm training with rhythmic auditory cueing improves motor function in chronic hemiparetic stroke. Stroke. 2000 Oct;31(10):2390-5. doi: 10.1161/01.str.31.10.2390. |
| 10661755 | Background | Mudie MH, Matyas TA. Can simultaneous bilateral movement involve the undamaged hemisphere in reconstruction of neural networks damaged by stroke? Disabil Rehabil. 2000 Jan 10-20;22(1-2):23-37. doi: 10.1080/096382800297097. |
| BG001 | cNMES | cNMES - Cyclic NeuroMuscular Electrical Stimulation.
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | cNMES | cNMES - Cyclic NeuroMuscular Electrical Stimulation.
|
|
|
| Secondary | Finger Tracking Error | A 30-sec 0.1Hz sine wave track scrolled from right to left on a computer screen in front of the participant. The amplitude of the sine wave was scaled to match the middle 70% of the participant's voluntary finger active range of motion (AROM). A cursor on the computer screen moved up and down as the participant extended and flexed their index finger. The task was to trace the scrolling sine wave with the cursor. Tracking error was the average vertical distance between the cursor and the target trace. Since the track was scaled to the participant's finger AROM, the distance between the cursor and the target trace (and therefore the tracking error) is in units corresponding to the percentage (%) of the participant's finger active range of motion (AROM), hereafter abbreviated %AROM. | The participants who completed the 6-week treatment phase were included in the analysis. | Posted | Mean | Standard Error | % AROM | 3 months post-treatment. |
|
|
|
| Secondary | Box and Blocks Score | The number of blocks picked up and moved across a barrier in 60 seconds | The participants who completed the 6-week treatment phase were included in the analysis. | Posted | Mean | Standard Error | blocks | 3 months post-treatment. |
|
|
|
| Secondary | Arm Motor Abilities Test | The Arm Motor Abilities Test (AMAT) score is an average across 9 different compound activities of daily living (ADL) tasks composed of 1 to 3 component tasks, each of which was scored by a therapist using a 0 to 5 ordinal scale: 0, no attempt to use affected limb; 1, attempt to use affected limb but it doesn't participate functionally; 2, affected limb is used only as a helper or stabilizer; 3, affected limb is used slowly or within synergy patterns; 4, affected limb use almost normal; 5, normal use. Each of the 9 tasks is scored and then the average score across the 9 tasks is calculated, with a range of 0 to 5. | The participants who completed the 6-week treatment phase were analyzed. | Posted | Mean | Standard Error | units on a scale | 3 months post-treatment. |
|
|
|
| Secondary | Fugl-Meyer Assessment (Upper Extremity) | The participant was asked to perform specific coordinated and isolated shoulder, elbow, wrist, and hand movements. Each movement was rated by a therapist using a 3-point ordinal scale: 0, cannot perform; 1, perform partially; 2, perform fully) and summed to produce an overall score, with a range of 0 to 66 (the higher the score the better). | The participants who completed the 6-week treatment phase were analyzed. | Posted | Mean | Standard Error | units on a scale | 3 months post-treatment. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | cNMES | cNMES - Cyclic NeuroMuscular Electrical Stimulation.
| 0 | 11 | 0 | 11 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |