Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
NCT ID: NCT02199795
Last Updated: 2017-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
7 participants
INTERVENTIONAL
2014-05-31
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Interventions
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Contralaterally Controlled Neuromuscular Electrical Stimulation
Cyclic Neuromuscular Electrical Stimulation
Eligibility Criteria
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Inclusion Criteria
* Minimum of 2 wks from a first clinical non-hemorrhagic or hemorrhagic stroke
* Medically stable
* Unilateral lower extremity hemiparesis
* Ankle dorsiflexor strength of ≤4/5 on the Medical Research Council scale, while seated
* NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
* Full voluntary ROM of the contralateral ankle
* Skin intact on bilateral lower extremities
* Able to don the NMES system or caregiver available to assist with device if needed.
* Able to hear and respond to stimulator auditory cues
* Able to follow 3-stage commands
* Able to recall 2 of 3 items after 30 minutes
* Cognition and communication adequate for safe use of the device based on neurological assessment by physician principal investigator
Exclusion Criteria
* History of peroneal nerve injury
* History of Parkinson's, spinal cord injury, traumatic brain injury, or multiple sclerosis
* Uncontrolled seizure disorder
* Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
* Edema of the paretic lower extremity
* Absent sensation of paretic lower extremity
* Evidence of deep venous thrombosis or thromboembolism
* History of cardiac arrhythmias with hemodynamic instability
* Cardiac pacemaker or other implanted electronic system
* Botulinum toxin injections to any lower extremity muscle in the last 3 months
* Pregnancy
* Symptomatic peripheral neuropathy
* Current use of psychoactive medications (except selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor antidepressants)
* Acetylcholinesterase inhibitor usage
* Unstable asthmatic condition
* Metallic implants (including clips and/or wires)
* Prosthetic heart valves
* Cardiac, renal or other stent
* History of claustrophobia
* Low visual acuity
* Body weight or body habitus not compatible to MRI machine
* Medical, psychological, or social concern identified by the principal investigator or co-investigator which suggests inappropriateness of subject participation
21 Years
75 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Case Western Reserve University
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
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Jayme Knutson
Assistant Professor, Physical Medicine and Rehabilitation
Principal Investigators
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Lynne R. Sheffler, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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References
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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.
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.
Swinnen SP. Intermanual coordination: from behavioural principles to neural-network interactions. Nat Rev Neurosci. 2002 May;3(5):348-59. doi: 10.1038/nrn807.
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.
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.
Related Links
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Cleveland Functional Electrical Stimulation Center