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Effects of Voluntary Adjustments During Walking in Participants Post-stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Split belt treadmill
Biofeedback
Sponsored by
Chapman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring Walking, Gait, Motor control, Neurorehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for stroke survivors are: Chronic hemiparesis (time since stroke > 6 months) caused by a single documented stroke event. Ability to walk on the treadmill continuously for 2 minutes Ability to walk over ground independently or with the use of a cane No concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk No prior experience walking on a split-belt treadmill Normal or corrected to normal vision The ability for them or a guardian to provide informed consent. Inclusion criteria for neurotypical adults are: No musculoskeletal conditions or injuries that limit walking ability within the last two years No history of neurological disorders or severe head trauma No prior experience walking on a split-belt treadmill Normal or corrected to normal vision. Exclusion Criteria for stroke survivors are: Inability to walk Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk More than one stroke Visual neglect Uncontrolled hypertension Inability to provide informed consent. Exclusion Criteria for neurotypical controls are: Inability to walk Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk Uncontrolled hypertension Inability to provide informed consent.

Sites / Locations

  • Chapman UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke participants

Neurotypical participants

Arm Description

Researchers will assess muscle control in participants post-stroke during different types of walking modifications

Researchers will compare muscle control to neurotypical participants during the same types of walking modifications to assess stroke-induced changes in muscle control vs. intervention-induced changes in muscle control

Outcomes

Primary Outcome Measures

VAF1 - variance accounted for in a single muscle activation module
Using non-negative matrix factorization researchers will evaluate the coordinated co-activation of muscles during walking. If muscles are more co-activated, a single module will account for more variance in muscle activation data. For impaired muscle control, VAF1 will be closer to 1, for better muscle control, VAF1 will be closer to 0.
walkDMC - walking Dynamic Motor Control Index
variance accounted for by a single module relative to control participants. A value greater than 1 indicates impaired control relative to controls

Secondary Outcome Measures

Muscle activation modules
To compare results to previous studies assessing neuromuscular control, researchers will identify in each individual the number of muscle activation modules that account for 90% of the variance in muscle activation data. More modules indicates the ability to control muscles independently and therefore less impairment
Compensation measures - hip hiking
To determine whether explicit and implicit adjustments lead individuals to increase hip hiking, which is an increase in the non-pareteic coronal hip and/or pelvic angle when the affected limb is in midswing. Hip hiking is a strategy used to compensate for the insufficient flexion of the hip joint during the swing phase, as well as knee flexion and ankle dorsiflexion, thus shortening the paretic limb. Measured in degrees
Compensation measures - hip circumduction
To determine whether explicit and implicit adjustments lead individuals to increase hip circumduction, in which the patient abducts their thigh and swings their leg in a semi-circle to attain adequate clearance during swing. Measured in degrees
Compensation measures - overreliance on the non-paretic extremity to generate propulsion
The paretic limb's contribution to forward propulsion. Defined as calculated as a ratio of the paretic limb's propulsive force divided by the sum of the paretic and non-paretic limb's force. Measured as a percentage.
Compensation measures - step width
The distance between both feet during the double support phase of gait. Measured in milimiters

Full Information

First Posted
July 26, 2023
Last Updated
September 11, 2023
Sponsor
Chapman University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT06034119
Brief Title
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
Official Title
Determining the Effects of Increased Demands for Voluntary Adjustments on the Neuromuscular Control of Walking Post-stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chapman University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
People post-stroke retain the capacity to modify walking patterns explicitly using biofeedback and implicitly when encountering changes in the walking environment. This proposal will assess changes in muscle activation patterns associated with walking modifications driven explicitly vs. implicitly, to determine whether individuals generate different amounts of co-contraction during explicit vs. implicit walking modifications. Understanding how walking modifications driven explicitly vs. implicitly influence co-contraction will allow the investigators to identify approaches that can more effectively restore muscle activation toward pre-stroke patterns, promoting mechanism-based recovery of walking function.
Detailed Description
This proposal aims to determine the effects of explicitly driven or implicitly driven walking modifications on muscle activation patterns and co-contraction post-stroke. This work is significant, as studies have shown that muscle activation patterns after neurologic injury cannot generate walking kinematics comparable to those seen in neurotypical individuals; this finding implies that to attain true walking recovery after neurologic injury, interventions should aim to restore the muscle activations underlying walking behaviors. Here, the researchers first explore muscle activations during walking using biofeedback to guide explicit modification of walking patterns, which is a common approach used in clinical and research interventions for walking retraining. The hypothesis is that explicit walking modifications might be detrimental at a muscle activation level as they engage cortical pathways for voluntary control that have been interrupted by the stroke lesion, resulting in increased muscle co-contraction. Co-contraction hinders true recovery as it impairs the ability to selectively control different segments during walking, resulting in overreliance on compensatory patterns. Researchers will also explore muscle activation patterns during implicit walking modifications. Researchers will use external modifications in the walking environment, mainly split-belt adaptation followed by tied belt walking, to assess if implicit modifications of walking that rely less on cortical neural control are associated with levels of cocontraction comparable to neurotypical controls-an indication that implicitly-mediated modifications could be a more effective approach to restore muscle activation patterns during walking post-stroke. In this study, researchers will assess co-contraction during walking in people post-stroke as the patient reduces asymmetry in step lengths guided by explicit biofeedback (Aim 1) or implicitly following split-belt adaptation and washout (Aim 2). Results from this study will identify the tasks and conditions that can reduce cocontraction to promote restoration of neuromuscular control post-stroke. This proposal will aid develop objective markers of treatment response and functional progress that predict rehabilitation treatment response and enable the tailoring of interventions to the needs, abilities, and resources of the person with disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Walking, Gait, Motor control, Neurorehabilitation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A group of participants post-stroke and neurotypical controls will be recruited for this study. All individuals will perform all conditions
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stroke participants
Arm Type
Experimental
Arm Description
Researchers will assess muscle control in participants post-stroke during different types of walking modifications
Arm Title
Neurotypical participants
Arm Type
Active Comparator
Arm Description
Researchers will compare muscle control to neurotypical participants during the same types of walking modifications to assess stroke-induced changes in muscle control vs. intervention-induced changes in muscle control
Intervention Type
Behavioral
Intervention Name(s)
Split belt treadmill
Intervention Description
Participants will walk on a dual belt treadmill with each belt moving at a different speed which is known as a split belt treadmill to provide implicit modifications of the walking pattern
Intervention Type
Behavioral
Intervention Name(s)
Biofeedback
Intervention Description
The Gait Real-time Analysis Interactive Lab (GRAIL) system has an immersive virtual reality screen that provides real-time information to participants of their walking pattern and provides visual instructions on how to walk more symmetrically
Primary Outcome Measure Information:
Title
VAF1 - variance accounted for in a single muscle activation module
Description
Using non-negative matrix factorization researchers will evaluate the coordinated co-activation of muscles during walking. If muscles are more co-activated, a single module will account for more variance in muscle activation data. For impaired muscle control, VAF1 will be closer to 1, for better muscle control, VAF1 will be closer to 0.
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Title
walkDMC - walking Dynamic Motor Control Index
Description
variance accounted for by a single module relative to control participants. A value greater than 1 indicates impaired control relative to controls
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Secondary Outcome Measure Information:
Title
Muscle activation modules
Description
To compare results to previous studies assessing neuromuscular control, researchers will identify in each individual the number of muscle activation modules that account for 90% of the variance in muscle activation data. More modules indicates the ability to control muscles independently and therefore less impairment
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Title
Compensation measures - hip hiking
Description
To determine whether explicit and implicit adjustments lead individuals to increase hip hiking, which is an increase in the non-pareteic coronal hip and/or pelvic angle when the affected limb is in midswing. Hip hiking is a strategy used to compensate for the insufficient flexion of the hip joint during the swing phase, as well as knee flexion and ankle dorsiflexion, thus shortening the paretic limb. Measured in degrees
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Title
Compensation measures - hip circumduction
Description
To determine whether explicit and implicit adjustments lead individuals to increase hip circumduction, in which the patient abducts their thigh and swings their leg in a semi-circle to attain adequate clearance during swing. Measured in degrees
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Title
Compensation measures - overreliance on the non-paretic extremity to generate propulsion
Description
The paretic limb's contribution to forward propulsion. Defined as calculated as a ratio of the paretic limb's propulsive force divided by the sum of the paretic and non-paretic limb's force. Measured as a percentage.
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing
Title
Compensation measures - step width
Description
The distance between both feet during the double support phase of gait. Measured in milimiters
Time Frame
Measured day 1 and day 2 of the study while individuals are walking on the treadmill. first and last 10 strides on Day 1 and Day 2 of testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for stroke survivors are: Chronic hemiparesis (time since stroke > 6 months) caused by a single documented stroke event. Ability to walk on the treadmill continuously for 2 minutes Ability to walk over ground independently or with the use of a cane No concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk No prior experience walking on a split-belt treadmill Normal or corrected to normal vision The ability for them or a guardian to provide informed consent. Inclusion criteria for neurotypical adults are: No musculoskeletal conditions or injuries that limit walking ability within the last two years No history of neurological disorders or severe head trauma No prior experience walking on a split-belt treadmill Normal or corrected to normal vision. Exclusion Criteria for stroke survivors are: Inability to walk Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk More than one stroke Visual neglect Uncontrolled hypertension Inability to provide informed consent. Exclusion Criteria for neurotypical controls are: Inability to walk Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk Uncontrolled hypertension Inability to provide informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Sanchez, PhD
Phone
7145165503
Email
sanchezaldana@chapman.edu
Facility Information:
Facility Name
Chapman University
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Sanchez, PhD
Phone
714-516-5503
Email
sanchezaldana@chapman.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The Principal Investigator, is the leader of the Stroke Initiative for Gait Data Evaluation (STRIDE) database, available at The Archive of Data on Disability to Enable Policy and research (ADDEP, https://www.icpsr.umich.edu/web/pages/ADDEP/), a joint initiative of the Center for Large Data Research and Data Sharing in Rehabilitation (CLDR). ADDEP is supported by grant P2CHD065702 awarded to the CLDR by the NIH - National Institute of Child Health and Human Development, through the National Center for Medical Rehabilitation Research, the National Institute for Neurological Disorders and Stroke, and the National Institute of Biomedical Imaging and Bioengineering. The investigators will request to share the data for the present study in STRIDE. The investigators will share walking kinematic and EMG data. No identifiable information will be shared.

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Effects of Voluntary Adjustments During Walking in Participants Post-stroke

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