Tracking Post-stroke Walking Improvements From the Clinic Into the Home

NCT05454007 | Completed Results DMC

• 1 other identifier: P22/IRB/029
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this proposal is to use novel video-based movement tracking technology to measure gait quality after stroke - in the home. Current rehabilitation practice assesses walking in the highly controlled 'ideal' clinical environment. The implicit assumption by clinicians and researchers is that the way people walk in the clinic (their best capacity) reflects the way they walk in the real-world (true performance). With advances in computer vision and development of pose estimation algorithms, it is now possible to directly measure how people are walking in their homes. It is critical that researchers apply this technology to examine the basic assumptions that underlie current rehabilitation practice. Here, a video-based pose estimation workflow will be used to 1) contrast the gait patterns of persons post-stroke as observed in-clinical vs. in-home settings, and 2) map the rate of deterioration of clinically-derived walking improvements, in the home. This methodology has been used to accurately measure gait kinematics in people with stroke as they walk in laboratory, however this study now seeks to use these methods to record people with stroke as they walk in their natural home environments. The ultimate outcome of this project will not only be freely-available video-based workflow modified for home-based gait assessments, but also preliminary data revealing how people with stroke walk in the real world.

Conditions

Stroke; Healthy Adult

Keywords

gait; step length asymmetry; walking

Outcome Measures

Primary Outcomes (4)

• Step Length Asymmetry

  The normalized difference between short step length and long step length; a spatial parameter absolute value of (left step length - right step length) / left step length + right step length Will be compared across timepoints.

  In-clinic baseline (day 1), in-home baseline (day 1)

• Step Time Symmetry

  The normalized difference between short step time and long step time; a temporal parameter (absolute value(left step time- right step time))/(left step time + right step time) Will be compared across timepoints.

  In-clinic baseline (day 1), in-home baseline (day 1)

• Self Selected Gait Speed

  The speed at which a participant is walking (meters/second) Will be compared across timepoints.

  In-clinic baseline (day 1), in-home baseline (day 1)

• Step Length Asymmetry (Transfer)

  The normalized difference between short step length and long step length; a spatial parameter absolute value of (left step length - right step length) / left step length + right step length

  Aim 2: clinic before training, clinic after training, same day transfer, 1-day transfer, 3-day transfer, 1-week transfer

Other Outcomes (2)

• Depression Via PHQ-9

  Measured once, during the first session which takes place on a single day.

• Berg Balance Scale

  Measured once, during the first session which takes place on a single day.

Study Arms (2)

Individuals with Stroke

EXPERIMENTAL

Individuals with stroke who meet inclusion and exclusion criteria were included in Aim 1 and Aim 2 of the study. In aim 1, they engaged in a standard neurological screen and participated in clinic- and home-based walking trials. In Aim 2, they underwent a single session of step length symmetry training and submitted a series of home walking videos to track how durable improvements were from the clinic to home.

Behavioral: Step length asymmetry training

Neurologically Intact Adults

NO INTERVENTION

Healthy Adults/Adults without Stroke participated in Aim 1, but not Aim 2 of the study. They underwent the same screening and neurological assessment as participants with stroke and performed clinic-based and home-based walking trials. They did not receive intervention.

Interventions

Step length asymmetry training BEHAVIORAL

For aim 2, participants with stroke engaged in five, two-minute periods of step symmetry training during session 2. This training uses established sensorimotor adaptation-based methods (e.g. split-belt treadmill walking, walking with unilateral leg weighting) to elicit motor aftereffects of more equal step lengths. Two minute sitting rest breaks will be given between training blocks or at the participant's request. A video recording will be taken of the first and final period of training.

Individuals with Stroke

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stroke \>6 months prior
• hemiparetic gait pattern with step length difference of 2cm or greater
• able to ambulate whiteout physical assistance from another person (use of an assistive device are acceptable), gait speed \>/= 0.2m/s
• normal or corrected-to-normal vision

You may not qualify if:

• neurological condition other than stroke
• aphasia limiting comprehension of task instructions pregnancy
• uncontrolled hypertension (\> 150/90 mmHg at rest)
• dementia, cognitive impairments, or psychiatric disorders limiting the ability to provide informed consent
• epilepsy
• orthopedic or pain conditions limiting walking
• concurrent engagement in physical therapy or other research study.

Sponsors & Collaborators

• Western University of Health Sciences: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Western University of Health Sciences

Lebanon, Oregon, 97355, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Kendra Cherry-Allen, PhD, PT, DPT
• Organization: Western University of Health Sciences

kcherryallen@westernu.edu

541.259.0473

Study Officials

• Kendra Cherry-Allen, PhD, PT, DPT

  Western University of Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Aim 1, which is a direct comparison of how people walk in the clinic and in the home, will include both adults with stroke and neurologically intact adults. Aim 2 which assesses the durability of step symmetry improvements in the real world, will only involve the participants with stroke.

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 12, 2022
• Study Start: August 25, 2022
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: July 24, 2026
• Results First Posted: July 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Software will be posted to GitHub repository upon the conclusion of the study and will remain open access and freely available indefinitely.
• Access Criteria: De-identified data will be curated and deposited to appropriate public repositories whenever applicable. All behavioral data will be made available per reasonable request to the PI and all software will be made available on our GitHub archive.

Locations

US (1)