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RecruitingNCT03916562Updated May 23, 2023

Optimization Principles in Hemiparetic Gait

An interventional study of Manipulation of spatiotemporal coordination during walking in Stroke, sponsored by University of Southern California. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by University of Southern California · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled Nov 2018, registered Mar 2019).
  • Started Nov 2018; still recruiting 7 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Non-randomized
Ages
21 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

Keywords

  • Walking
  • Gait
  • Stability
  • Energetic cost
03

In context

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Healthy Participants

    The investigators will determine how asymmetric walking constraints influence spatiotemporal coordination, energetic cost, and dynamic balance in healthy individuals. The investigators will manipulate spatiotemporal coordination using a special treadmill. Energetic cost will be quantified using expired gas analysis and inverse dynamic approaches. Stability will be evaluated by characterizing participants' ability to recover from unexpected perturbations.

    Behavioral: Manipulation of spatiotemporal coordination during walking

  • Experimental
    Post-stroke Participants

    The investigators will determine how different patterns of coordination during walking influence energetic cost and dynamic balance in people post-stroke. The investigators will manipulate coordination using a special treadmill. Energetic cost will be quantified using expired gas analysis and inverse dynamic approaches. Stability will be evaluated by characterizing participants' ability to recover from unexpected perturbations.

    Behavioral: Manipulation of spatiotemporal coordination during walking

Interventions

  • BehavioralManipulation of spatiotemporal coordination during walking

    A description of the intervention is included in the description of the study arms.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the beginning of study day one

  2. 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.

    Time frame: During study day one

  3. Angular momentum during walking

    Motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill

    Time frame: At the beginning of study day two

  4. 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.

    Time frame: During study day two

07

Study locations

1 of 1 sites recruiting
  • University of Southern California
    Los Angeles, California 90033, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29998788 ↗
  • 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. PubMed 29997488 ↗
  • 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. PubMed 28794494 ↗
  • 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. PubMed 27798378 ↗
  • 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. PubMed 25589580 ↗
  • Park S, Liu C, Sanchez N, Tilson JK, Mulroy SJ, Finley JM. Using Biofeedback to Reduce Step Length Asymmetry Impairs Dynamic Balance in People Poststroke. Neurorehabil Neural Repair. 2021 Aug;35(8):738-749. doi: 10.1177/15459683211019346. Epub 2021 Jun 1. PubMed 34060926 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03916562
Lead sponsor
University of Southern California
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
James Finley (Assistant Professor, University of Southern California) — Principal investigator
First posted
Apr 16, 2019
Start date
Nov 13, 2018
Primary completion
Nov 30, 2023 (estimated)
Completion
Nov 30, 2023 (estimated)
Last update
May 23, 2023

Study contacts

James Finley, Ph.D.
Contact
jmfinley@pt.usc.edu
3234424837

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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