The research is being done to find out if Functional Electrical Stimulation (FES) stepping can improve the function of people with spinal cord injury that paralyzes.
Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion of the legs. The FES stepping in this study will be done through a device called the RT600 FES Stepper (RT600).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
You will be transferred to the RT600 device and secured in a support harness. We will place your legs onto the RT600 device and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs, buttock, stomach, and back. The pads will be connected to a stimulator box through a wire. We will then start the stepping motor and stimulate your muscles with electric current. This will cause your legs to step. You will do this for 1 hour.
Kennedy Krieger Institute
Baltimore, Maryland, United States
Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)
Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome. AIS Classificatrion: A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5. B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more. E = Normal: motor and sensory function are normal.
Time frame: Baseline, 8 weeks
Change in Heart Rate
Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.
Time frame: Baseline, 8 weeks
Change in Systolic Blood Pressure
Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.
Time frame: Baseline, 8 weeks
Change in Diastolic Plood Pressure
Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.
Time frame: Baseline, 8 weeks
Change in Rate of Perceived Exertion
Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters. The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion.
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Time frame: Baseline, 8 weeks
Change in Vital Capacity
Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.
Time frame: Baseline, 8 weeks
Change in Peak Cough Flow
Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.
Time frame: Baseline, 8 weeks