Optimization Principles in Hemiparetic Gait

Stroke Clinical Trial

Official title:

Toward a Mechanistic Understanding of Optimization Principles Underlying Hemiparetic Gait

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916562
• Other study ID #: HS-18-00533
• Secondary ID: R01HD091184
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: University of Southern California
• Contact: James Finley, Ph.D.
• Phone: 3234424837
• Email: jmfinley[@]pt.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project seeks to identify the how walking impairments in stroke survivors contribute to mobility deficits through the use of behavioral observations and computational models. The chosen approach integrates biomechanical analyses, physiological assessments and machine learning algorithms to explain how asymmetries during walking influence balance and the effort required to walk. Ultimately, the results of this work may lead to more personalized rehabilitation strategies to improve walking capacity and efficiency, and ultimately reduce fall risk in stroke survivors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria for Control Participants:

• No musculoskeletal injury or conditions that limit walking ability
• No history of neurological disorders or severe head trauma
• Absence of cognitive impairment as demonstrated by a Mini-Mental score greater than 24 Inclusion Criteria for Post-Stroke Participants
• Presence of unilateral brain lesion from a single stroke
• Weakness confined to one side
• Ability to walk on a treadmill for five minutes continuously without a cane or walker
• Absence of cognitive impairment as demonstrated by a Mini-Mental score greater than 24

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Manipulation of spatiotemporal coordination during walking
A description of the intervention is included in the description of the study arms.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Finley JM, Bastian AJ. Associations Between Foot Placement Asymmetries and Metabolic Cost of Transport in Hemiparetic Gait. Neurorehabil Neural Repair. 2017 Feb;31(2):168-177. doi: 10.1177/1545968316675428. Epub 2016 Oct 22. — View Citation

Finley JM, Long A, Bastian AJ, Torres-Oviedo G. Spatial and Temporal Control Contribute to Step Length Asymmetry During Split-Belt Adaptation and Hemiparetic Gait. Neurorehabil Neural Repair. 2015 Sep;29(8):786-95. doi: 10.1177/1545968314567149. Epub 2015 Jan 14. — View Citation

Liu C, Macedo L, Finley JM. Conservation of Reactive Stabilization Strategies in the Presence of Step Length Asymmetries During Walking. Front Hum Neurosci. 2018 Jun 27;12:251. doi: 10.3389/fnhum.2018.00251. eCollection 2018. — View Citation

Sanchez N, Finley JM. Individual Differences in Locomotor Function Predict the Capacity to Reduce Asymmetry and Modify the Energetic Cost of Walking Poststroke. Neurorehabil Neural Repair. 2018 Aug;32(8):701-713. doi: 10.1177/1545968318787913. Epub 2018 Jul 12. — View Citation

Sanchez N, Park S, Finley JM. Evidence of Energetic Optimization during Adaptation Differs for Metabolic, Mechanical, and Perceptual Estimates of Energetic Cost. Sci Rep. 2017 Aug 9;7(1):7682. doi: 10.1038/s41598-017-08147-y. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen consumption (VO2)	The investigators will use a metabolic cart to measure the rate of oxygen consumption (VO2) while participants walk at a fixed speed on a treadmill.	At the beginning of study day one
Primary	Correlation between oxygen consumption (VO2) and step length asymmetry	The investigators will use a metabolic cart to measure the rate of oxygen consumption (VO2) while participants walk at a fixed speed on a treadmill. VO2 will be measured in five trials where participants walk with different levels of step length asymmetry. This outcome will capture the relationship between measures of VO2 and step length asymmetry.	During study day one
Primary	Angular momentum during walking	Motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill	At the beginning of study day two
Primary	Correlation between angular momentum and step length asymmetry during walking	Participants will complete five trials at different levels of step length asymmetry. During these trials, motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill. This outcome measure will use data from all trials to determine the relationship between angular momentum and step length asymmetry.	During study day two