NCT03916562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

5 years

First QC Date

March 31, 2019

Last Update Submit

May 19, 2023

Conditions

Stroke

Keywords

WalkingGaitStabilityEnergetic cost

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Healthy Participants

EXPERIMENTAL

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

Post-stroke Participants

EXPERIMENTAL

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

Manipulation of spatiotemporal coordination during walkingBEHAVIORAL

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

Healthy ParticipantsPost-stroke Participants

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 29998788BACKGROUND

  • 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.

    PMID: 29997488BACKGROUND

  • 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.

    PMID: 28794494BACKGROUND

  • 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.

    PMID: 27798378BACKGROUND

  • 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.

    PMID: 25589580BACKGROUND

  • 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.

    PMID: 34060926DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

James Finley, Ph.D.

CONTACT

3234424837jmfinley@pt.usc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 16, 2019

Study Start

November 13, 2018

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations

US(1)