This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
OBJECTIVES: * To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke * To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke * To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke * To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke * To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneousnon-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.
May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
Participant in the Healthy Control Group will participate in up to 3 assessment sessions in order to obtain comparative data for Spinal Motor Evoked Potentials (MEPs), lower extremity MVC's, sidelying EMG data and overground EMG data
Shirley Ryan AbilityLab
Chicago, Illinois, United States
RECRUITINGChange in Gait Symmetry
Participants will ambulate along Gait Rite electronic walkway up to 12 times (3 times per gait speed with and without lower extremity orthotics) to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet and connected to a computer. The system can be laid over any flat surface and automates measuring temporal and spatial gait parameters. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality.
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in 10 Meter Walk Test
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec). The test will be recorded up to 12 times (3 times at each gait speed with and without lower extremity orthotics if safe and appropriate).
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in 6 Minute Walk Test Using VO2 Analysis
The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a portable gas analysis system called the Cosmed K4B2 to measure oxygen consumption. This system measures oxygen consumption (VO2) and Carbon-dioxide production (VCO2) in a breath by breath fashion.
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Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
4. Locomotion assessment for intra limb coordination using electromyography (EMG) on GaitRite
Locomotion assessment for inter and intra limb coordination using wearable sensors and EMG sensors. Participants ambulate along Gait Rite electronic walkway up to 12 times (3 times at each gait speed with and without lower extremity orthotics if safe and appropriate) to evaluate gait pattern and lower extremity muscle activity at both self-selected and fast but safe gait speed. The sensors used will include those available from the BioStampRC Discovery Kit (MC10,Inc.), EMG sensors and custom sensors designed by the John Rogers research group at Northwestern University. The wearable sensors will collect the following information: Biometric data, including electrocardiography (EKG) and electromyography(EMG). Movement data from the limbs including signals from triaxial accelerometers (ACC) and gyroscopes (GYR). The rate of sweating and glucose concentration using microfluidic sweat sensor.
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Spinal Motor Evoked Potentials (MEPs)
Spinal Motor Evoked Potentials (MEPs) will be obtained by stimulating between the spinous processes of up to 5 vertebrae with a single pulse. MEPs are the electromyograph responses of the peripheral muscles to electrical stimulation of the spinal cord. MEPs will be used to test the integrity of the motor pathways of the spinal cord. A Transcutaneous Spinal Cord Neurostimulator (BioStim-5 or NeuroEnabling Stimulator System) will deliver transcutaneous electrical spinal cord stimulation.
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change corticospinal excitability
Transcranial magnetic stimulation (TMS) will be used to assess changes in corticospinal excitability that may occur following repeated transcutaneous spinal stimulation and ambulation training. TMS is a safe, non-invasive, painless method of brain stimulation that widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. Very short duration (\< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram EMG from that muscle.
Time frame: Baseline, Post intervention
Change in Fugl-Meyer Assessment of Motor Recovery after Stroke
The purpose of the FMA is to evaluate and measure recovery in post-stroke hemiplegic patients. There are five domains assessed on a 3 point ordinal scale from 0-2. "0" is equal to "cannot perform", "1" is equal to "performs partially", and "2" is equal to "performs fully. The domains for upper and lower extremity motor function will be used.
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Stroke Impact Scale-16
Stroke Impact Scale-16 completed by patient to evaluate the impact of the stroke on the person's health and life from the individuals perspective. It is scored from 1-5, 1 signifying a major effect on the individual and 5 signifying little to no effect.
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change Static in Balance
During the static stability test, the participants will be instructed to stand on the force plate as still as possible for up to 60 seconds with their eyes open. After rest, the task will be repeated with the eyes closed. The excursions of the center of pressure (COP) and EMG of leg muscles will be analyzed. The AMTI Force System from Water Town, MA will be used to assess balance.
Time frame: Session 1 (baseline test, initial visit), Midpoint, Post intervention, 3 month follow-up, 6 month follow-up, 12 month follow-up