Physiological Complexity of Gait Over the First Six Months Post Stroke

Completed

Conditions studied: Stroke, Acute

In brief

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.

Key facts

Study ID

NCT02541578

Run by

University of Indianapolis

People needed

50

Starts

2015-08-11

Expected to finish

2018-09-30

Last updated by the study team

2019-10-09

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• within 1-month post unilateral, cortical, ischemic stroke
• has only experienced one stroke
• between the ages of 21-80
• able to walk a short distance (at least 14 meters) on level surfaces without physical assistance, with or without the use of an assistive device and/or orthosis
• able to follow at least two-step verbal instructions
• available for the entire period of the study (5-6 months)

You may not qualify if…

• hemorrhagic stroke
• bilateral hemispheric stroke
• stroke in the brainstem or cerebellum
• pre-existing neurological or current musculoskeletal conditions that would limit gait ability separate from the effects of stroke
• complications from other health conditions that could influence walking

Where it is running

• University of Indianapolis, Krannert School of Physical Therapy — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.