Trial Outcomes & Findings for Noninvasive Spinal Stimulation in Stroke (NCT NCT03714282)

Noninvasive Spinal Stimulation in Stroke

Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. 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. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-\|1-Nonparetic/(Paretic side)\|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.

Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. 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. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-\|1-Nonparetic/(Paretic side)\|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher scores = better outcome.

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).

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 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.

Participants completed the 6MWT as heart rate was recorded throughout the testing using a Polar H7 chest belt monitor. Prior to beginning the 6MWT, average resting heart rate was recorded for two minutes while the subject was seated and quiet. Cardiac efficiency during 6MWT was measured by physiological cost index (PCI), which reflects heart rate per meter walked. Reduced PCI indicates improved cardiac efficiency.