- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916562
Optimization Principles in Hemiparetic Gait
May 19, 2023 updated by: James Finley, University of Southern California
Toward a Mechanistic Understanding of Optimization Principles Underlying Hemiparetic Gait
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: James Finley, Ph.D.
- Phone Number: 3234424837
- Email: jmfinley@pt.usc.edu
Study Locations
-
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California
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Los Angeles, California, United States, 90033
- Recruiting
- University of Southern California
-
Contact:
- James Finley, PhD
- Phone Number: 323-442-4837
- Email: jmfinley@pt.usc.edu
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
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
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
A description of the intervention is included in the description of the study arms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At the beginning of study day one
|
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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.
|
During study day one
|
|
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
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At the beginning of study day two
|
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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.
|
During study day two
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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)
November 13, 2018
Primary Completion (Anticipated)
November 30, 2023
Study Completion (Anticipated)
November 30, 2023
Study Registration Dates
First Submitted
March 31, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 19, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HS-18-00533
- R01HD091184 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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