NCT06034119

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

July 26, 2023

Last Update Submit

September 22, 2025

Conditions

Stroke

Keywords

WalkingGaitMotor controlNeurorehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

  • 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

    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 Outcomes (5)

  • Muscle activation modules

    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

  • Compensation measures - hip hiking

    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

  • Compensation measures - hip circumduction

    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

  • Compensation measures - overreliance on the non-paretic extremity to generate propulsion

    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

  • Compensation measures - step width

    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

Study Arms (2)

Stroke participants

EXPERIMENTAL

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

Behavioral: Split belt treadmillBehavioral: Biofeedback

Neurotypical participants

ACTIVE COMPARATOR

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

Behavioral: Split belt treadmillBehavioral: Biofeedback

Interventions

Split belt treadmillBEHAVIORAL

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

Neurotypical participantsStroke participants
BiofeedbackBEHAVIORAL

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

Neurotypical participantsStroke participants

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • Inability to walk
  • Concurrent neurological disorders or orthopedic conditions that interfere with their ability to walk
  • Uncontrolled hypertension
  • Inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chapman University

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A group of participants post-stroke and neurotypical controls will be recruited for this study. All individuals will perform all conditions
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2023

First Posted

September 13, 2023

Study Start

September 7, 2023

Primary Completion

June 27, 2025

Study Completion

June 30, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)