Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MetroHealth Medical Center
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Change in Lower Extremity Fugl-Meyer Score at End of Treatment
Study Overview
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 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Contralaterally Controlled Neuromuscular Electrical Stimulation (Device)
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.
Intervention: Cyclic Neuromuscular Electrical Stimulation (Device)
Outcomes
Primary Outcomes
Change in Lower Extremity Fugl-Meyer Score at End of Treatment
Time Frame: Baseline and End of Treatment (6 weeks)
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.
Secondary Outcomes
- Change in Ankle Movement Tracking Error at End of Treatment(Baseline and End of Treatment (6 weeks))
- Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment(Baseline and End of Treatment (6 weeks))
- Change in 10-Meter Walk Test(Baseline and End of Treatment (6 weeks))
Investigators
Jayme Knutson
Assistant Professor, Physical Medicine and Rehabilitation
MetroHealth Medical Center