An observational study in Stroke, Acute, sponsored by University of Indianapolis. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by University of Indianapolis · Observational
Physiological complexity of gait, a measure of the interaction of multiple control mechanisms for walking within a biological system, is decreased in persons with chronic stroke compared to those without disability. Thus, it is assumed that the quantification of gait complexity represents the adaptability and health of the individual. However, it is unknown if the level of gait-related complexity improves over time with recovery from stroke. Therefore, the primary purpose of this study is to determine if the physiological complexity of gait changes over the first six months post stroke within the contemporary healthcare environment. Secondary aims include 1) determining if there is a difference between the amount of physiological complexity of gait and lateralization of hemispheric damage after stroke and 2) exploring the relationship of complexity to lower extremity motor impairment, walking speed and balance. Sixty individuals within one month post stroke from the greater Indianapolis area will be recruited for this prospective, longitudinal outcomes study. Testing sessions will occur at intervals across the first six months post stroke: within 1 month, at 3 months, and at 6 months post stroke. During each testing session, participants will complete a 2-minute walking task during which accelerometer signals from wireless inertial measurement units will be collected and converted to sample entropy to quantify the physiological complexity of gait. Additionally, measures to quantify lower extremity motor impairment, walking speed and balance will be collected and analyzed. Changes in complexity of gait from early to later stages of stroke recovery may serve as a foundation for prognosticating outcomes, such as predicting capacity for community mobility and/or risk of fall. The proposed study will meet a critical need to develop methods that differentiate among capacities for adapting movement patterns in individuals with neurological dysfunction. This work will ultimately build upon evidence that will assist therapists in tailoring interventions in such a way to optimize function.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 50 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →University of Indianapolis is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 60 adults with acute stroke will be enrolled in this prospective, longitudinal cohort study.
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Exclusion Criteria:
Change in physiological complexity index of gait over 6 months
Participants will complete a 2-minute walking task on a level indoor surface using their preferred pace during which accelerometer signals from wireless inertial measurement units will be collected. This data will be used to calculate multivariate multiscale sample entropy in order to quantify the complexity index in all lower segments (thigh, shank, foot) and pelvis during gait.
Time frame: Within 1 month, 3 months and 6 months post stroke
Ran from Aug 2015 to primary completion in Sep 2018, 37 months.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's 37 months is close to that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University of Indianapolis