Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

N/ACompletedNCT02199795

MetroHealth Medical Center7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Hemiparesis Footdrop

Interventions

Contralaterally Controlled Neuromuscular Electrical StimulationDEVICE

Cyclic Neuromuscular Electrical StimulationDEVICE

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

MetroHealth Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and End of Treatment (6 weeks)

Secondary Outcomes

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.

Time frame: Baseline and End of Treatment (6 weeks)

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.

Data from ClinicalTrials.gov

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