Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

Completed · Not applicable

Conditions studied: Stroke, Hemiparesis, Footdrop

In brief

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.

Key facts

Study ID

NCT02199795

Run by

MetroHealth Medical Center

People needed

7

Starts

2014-05-01

Expected to finish

2015-02-01

Last updated by the study team

2017-11-08

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MetroHealth Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.