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| ID | Type | Description | Link |
|---|---|---|---|
| K23HD060689 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Case Western Reserve University | OTHER |
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This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos) and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCNMES | Experimental | Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax. |
|
| Cyclic NMES | Active Comparator | Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contralaterally Controlled Neuromuscular Electrical Stimulation | Device |
| ||
| Cyclic Neuromuscular Electrical Stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Extremity Fugl-Meyer Score at End of Treatment | The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34). Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. | Baseline and End of Treatment (6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 10-Meter Walk Test | Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged. | Baseline and End of Treatment (6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynne R. Sheffler, MD | 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 |
|---|---|---|---|
| 23867888 | Background | Knutson JS, Hansen K, Nagy J, Bailey SN, Gunzler DD, Sheffler LR, Chae J. Contralaterally controlled neuromuscular electrical stimulation for recovery of ankle dorsiflexion: a pilot randomized controlled trial in patients with chronic post-stroke hemiplegia. Am J Phys Med Rehabil. 2013 Aug;92(8):656-65. doi: 10.1097/PHM.0b013e31829b4c16. | |
| 20531158 | Background | Knutson JS, Chae J. A novel neuromuscular electrical stimulation treatment for recovery of ankle dorsiflexion in chronic hemiplegia: a case series pilot study. Am J Phys Med Rehabil. 2010 Aug;89(8):672-82. doi: 10.1097/PHM.0b013e3181e29bd7. |
| Label | URL |
|---|---|
| Cleveland Functional Electrical Stimulation Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | CCNMES | Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax. Contralaterally Controlled Neuromuscular Electrical Stimulation |
| FG001 | Cyclic NMES | Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down. Cyclic Neuromuscular Electrical Stimulation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CCNMES | Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax. Contralaterally Controlled Neuromuscular Electrical Stimulation |
| 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 | Change in Lower Extremity Fugl-Meyer Score at End of Treatment | The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34). Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. | Posted | Mean | Standard Deviation | units on a scale | Baseline and End of Treatment (6 weeks) |
|
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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 | CCNMES | Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax. Contralaterally Controlled Neuromuscular Electrical Stimulation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayme Knutson | MetroHealth Medical Center | 2169573557 | jsk12@case.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| D020427 | Peroneal Neuropathies |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Device |
|
| Change in Ankle Movement Tracking Error at End of Treatment |
Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point. Lower errors are considered to be better outcomes. For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement. |
| Baseline and End of Treatment (6 weeks) |
| Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment | The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time. Lower times are considered to be a better outcome. For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged. | Baseline and End of Treatment (6 weeks) |
| 11988774 | Background | Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807. |
| 15385590 | Background | Kawashima N, Nozaki D, Abe MO, Akai M, Nakazawa K. Alternate leg movement amplifies locomotor-like muscle activity in spinal cord injured persons. J Neurophysiol. 2005 Feb;93(2):777-85. doi: 10.1152/jn.00817.2004. Epub 2004 Sep 22. |
| 21516330 | Background | Vasudevan EV, Zehr EP. Multi-frequency arm cycling reveals bilateral locomotor coupling to increase movement symmetry. Exp Brain Res. 2011 Jun;211(2):299-312. doi: 10.1007/s00221-011-2687-y. Epub 2011 Apr 23. |
| BG001 | Cyclic NMES | Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down. Cyclic Neuromuscular Electrical Stimulation |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
Contralaterally Controlled Neuromuscular Electrical Stimulation
| OG001 | Cyclic NMES | Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down. Cyclic Neuromuscular Electrical Stimulation |
|
|
| Secondary | Change in 10-Meter Walk Test | Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged. | Posted | Mean | Standard Deviation | seconds | Baseline and End of Treatment (6 weeks) |
|
|
|
| Secondary | Change in Ankle Movement Tracking Error at End of Treatment | Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point. Lower errors are considered to be better outcomes. For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement. | Posted | Mean | Standard Deviation | units on a scale | Baseline and End of Treatment (6 weeks) |
|
|
|
| Secondary | Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment | The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time. Lower times are considered to be a better outcome. For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged. | Posted | Mean | Standard Deviation | seconds | Baseline and End of Treatment (6 weeks) |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Cyclic NMES | Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down. Cyclic Neuromuscular Electrical Stimulation | 0 | 3 | 0 | 3 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010243 | Paralysis |