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NCT02541578 · ClinicalTrials.gov registry record
Physiological Complexity of Gait Over the First Six Months Post Stroke
A clinical trial, sponsored by University of Indianapolis.
- Completed
- Registry status
- 50
- Enrollment target
NCT02541578: Completed study, sponsored by University of Indianapolis.
NCT02541578 is a clinical trial that has completed, run by University of Indianapolis. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02541578 has completed, sponsored by University of Indianapolis.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
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 ultim
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-08-11 |
| Est. Completion | 2018-09-30 |
What the finished NCT02541578 record still lists
NCT02541578 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02541578 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02541578 about?
NCT02541578 is a clinical study titled "Physiological Complexity of Gait Over the First Six Months Post Stroke". 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 adapta...
What is the current status of trial NCT02541578?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2015-08-11. Estimated completion is 2018-09-30.
Who is sponsoring clinical trial NCT02541578?
This trial is sponsored by University of Indianapolis, which has 9 total clinical trials registered on ClinicalTrials.gov.
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