Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:21 - 75
Updated:11/10/2017
Start Date:May 2014
End Date:February 2015

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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.


Inclusion Criteria:

- Age 21 to 75 years

- 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:

- Severely impaired cognition and communication

- 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
We found this trial at
1
site
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Lynne R. Sheffler, MD
Phone: 216-957-3558
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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mi
from
Cleveland, OH
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