Physiological Complexity of Gait Over the First Six Months Post Stroke

NCT02541578 | Completed

• 1 other identifier: 0721
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 ultimately build upon evidence that will assist therapists in tailoring interventions in such a way to optimize function.

Conditions

Stroke, Acute

Keywords

stroke, acute; gait, complexity

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 month, 3 months and 6 months post stroke

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 60 adults with acute stroke will be enrolled in this prospective, longitudinal cohort study.

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

Sponsors & Collaborators

• University of Indianapolis: lead
• Seattle University: collaborator

Study Sites (1)

University of Indianapolis, Krannert School of Physical Therapy

Indianapolis, Indiana, 46227, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephanie A Miller, PT, PhD, NCS

  University of Indianapolis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 4, 2015
• Study Start: August 11, 2015
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (1)