Physiological Complexity of Gait Over the First Six Months Post Stroke

October 7, 2019 updated by: Stephanie Miller, University of Indianapolis
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • University of Indianapolis, Krannert School of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physiological complexity index of gait over 6 months
Time Frame: Within 1 month, 3 months and 6 months post stroke
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Indianapolis

Collaborators

Seattle University

Investigators

  • Principal Investigator: Stephanie A Miller, PT, PhD, NCS, University of Indianapolis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2015

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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