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Optimization Principles in Hemiparetic Gait

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ClinicalTrials.gov Identifier: NCT03916562
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
James Finley, University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Manipulation of spatiotemporal coordination during walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: For this study, the investigators will recruit two separate groups of participants who will complete the study procedures in parallel. One group will be comprised of individuals post-stroke and the second group will be comprised of adults who have not had a stroke.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Toward a Mechanistic Understanding of Optimization Principles Underlying Hemiparetic Gait
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Arm Intervention/treatment
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
A description of the intervention is included in the description of the study arms.

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




Primary Outcome Measures :
  1. Oxygen consumption (VO2) [ Time Frame: At the beginning of study day one ]
    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.

  2. Correlation between oxygen consumption (VO2) and step length asymmetry [ Time Frame: During study day one ]
    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.

  3. Angular momentum during walking [ Time Frame: At the beginning of study day two ]
    Motion capture will be used to measure the kinematics of the body when participants respond to accelerations of the treadmill

  4. Correlation between angular momentum and step length asymmetry during walking [ Time Frame: During study day two ]
    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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916562


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

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: James Finley, PhD    323-442-4837    jmfinley@pt.usc.edu   
Sponsors and Collaborators
University of Southern California
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications:
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Responsible Party: James Finley, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03916562    
Other Study ID Numbers: HS-18-00533
R01HD091184 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Finley, University of Southern California:
Walking
Gait
Stability
Energetic cost