Status:
COMPLETED
Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Lead Sponsor:
MetroHealth Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Case Western Reserve University
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02199795
Start Date
May 1 2014
End Date
February 1 2015
Last Update
November 8 2017
Active Locations (1)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109