ClinicalTrials.gg
CompletedNCT05454007Updated Jul 24, 2026Results posted

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

An interventional study of Step length asymmetry training in Stroke and Healthy Adult, sponsored by Western University of Health Sciences. Completed at 1 site in United States. Open to participants aged 21 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
21 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Aim 1 Establish the relationship between walking capacity and walking performance in people with chronic stroke. The first critical step toward improving in-home walking performance after stroke is to uncover how differently people walk in the standard clinic environment vs. in their home. For each individual, the investigators will obtain video recordings of 6 minutes of walking in both clinic and home environments. The investigators will then use pose estimation algorithms to quantify three key features of gait- step length asymmetry, step time asymmetry, and gait speed. The investigators hypothesize that walking capacity measured in the clinic will be superior to walking performance measured in the home for each of the three metrics.

Aim 2 Quantify the magnitude and durability of clinic-derived walking improvements in the home. Current clinical practice is predicated on the belief that changes in walking capacity elicited through rehabilitation transfer to improvements in walking performance in the home. Here, the investigators will directly test this assumption. The same group of participants with stroke from Aim 1 will receive a single session of locomotor adaptation training - an established intervention shown to rapidly improve over ground step length symmetry - in the laboratory. Participants will then record videos as they perform in-home walking trials with instructions to continue to walk with their improved gait patterns at four timepoints (same day, next day, three-day, and one-week post-training). The investigators hypothesize that the improvement in step length symmetry in the home will be half of what is observed in the clinic on the same day and decay to zero by the next day.

Study Design Participants will complete a total of 5 data collection sessions (Figure 1). Day 1 will involve a standardized neurological clinical examination, a video recording of walking in the clinic (e.g. baseline capacity assessment), and a video recording of walking in the home (e.g. baseline performance assessment). Day 2 involves a single 30-minute training session in our laboratory during which the participant engages in an established protocol known to reduce step length asymmetry. They will also record a video of in-home walking (same-day transfer assessment) within an hour of completing the step symmetry training. On Days 3, 5, and 9, the participant will submit video recordings of their in-home walking.

Participants Investigators will recruit a single cohort of 20 people with post-stroke step length asymmetry ≥ 4 cm. Data gathered here will serve as necessary preliminary data for larger studies investigating factors that influence in-home walking performance and for studies testing interventions aimed at improving in-home walking.

Video Recording For assessments of walking capacity, the investigators will record videos (\~30 Hz) of sagittal and frontal views of participants as they walk overground on a level tile surface in a well-lit and distraction-free clinical setting. For assessments of walking performance, participants or members of their household will use a single stationary tablet or smart phone sampling at 30 Hz to record the participant as they walk in their homes (this will ideally be a sagittal recording, but can be frontal if space is limited - the investigators have pose estimation analysis workflows capable of measuring step lengths from both views). For a given transfer recording, participants will perform five walking trials at their preferred walking speeds.

Pose Estimation The investigators have developed pose estimation workflows for human gait analysis using the freely available pose estimation algorithm OpenPose. These workflows can provide accurate estimates of many spatiotemporal and kinematic gait parameters from both sagittal and frontal viewpoints and have been validated against ground-truth three-dimensional motion capture measurements for adults with and without stroke. These validation steps have also been performed for both overground and treadmill walking.

02

Conditions studied

  • Stroke
  • Healthy Adult

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Keywords

  • gait
  • step length asymmetry
  • walking
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 53 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Western University of Health Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria (participants with stroke only):

  • 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

Exclusion Criteria (all participants):

  • 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
  • epilepsy
  • orthopedic or pain conditions limiting walking
  • concurrent engagement in physical therapy or other research study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Individuals with Stroke

    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

  • No intervention
    Neurologically Intact Adults

    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

  • BehavioralStep length asymmetry training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: In-clinic baseline (day 1), in-home baseline (day 1)

  2. 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.

    Time frame: In-clinic baseline (day 1), in-home baseline (day 1)

  3. Self Selected Gait Speed

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

    Time frame: In-clinic baseline (day 1), in-home baseline (day 1)

  4. 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

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

Other outcomes

  1. Depression Via PHQ-9

    Depression will be assessed with the Patient Health Questionnaire (PHQ-9). This is a multipurpose self-report instrument for screening, diagnosing, monitoring and measuring the severity of depression. Each of 9 items are scored from 0 (not at all) - 3 (nearly every day). Total scores are reported. Total scores range from 0-27. Higher scores represent more severe depression. Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.

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

  2. Berg Balance Scale

    The Berg Balance Scale is a 14-item objective measure that assesses static balance and fall risk in adults. Scores range from 0-56 with higher scores representing better balance (better outcomes). Total scores are reported. Scores from 0 to 20 represent a high fall risk; scores 21 to 40 represent a medium fall risk; scores 41-56 represent a low fall risk.

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

07

Results

Posted Jul 24, 2026

Participant flow

Participants were recruited from local hospitals, medical facilities, support groups, and community businesses.

Participant flow — Overall Study
MilestoneIndividuals With StrokeNeurologically Intact Adults
Started2330
Completed2129
Not completed21
Withdrew: Withdrawal by subject21

Outcome measures

PrimaryStep 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.

Time frame:
In-clinic baseline (day 1), in-home baseline (day 1)
Reported as:
Mean · unitless
Step Length Asymmetry
unitlessIndividuals With StrokeNeurologically Intact Adults
Clinic Data - Baseline0.12 ± 0.110.07 ± 0.07
Home Data - Baseline0.15 ± 0.110.07 ± 0.04
PrimaryStep 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.

Time frame:
In-clinic baseline (day 1), in-home baseline (day 1)
Reported as:
Mean · unitless
Step Time Symmetry
unitlessIndividuals With StrokeNeurologically Intact Adults
Clinic Data - Baseline0.10 ± 0.140.05 ± 0.07
Home Data - Baseline0.11 ± 0.150.04 ± 0.02
PrimarySelf Selected Gait Speed

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

Time frame:
In-clinic baseline (day 1), in-home baseline (day 1)
Reported as:
Mean · m/s
Self Selected Gait Speed
m/sIndividuals With StrokeNeurologically Intact Adults
Clinic Data - Baseline0.70 ± 0.381.01 ± 0.28
Home Data - Baseline0.73 ± 0.471.07 ± 0.64
Other pre-specifiedDepression Via PHQ-9

Depression will be assessed with the Patient Health Questionnaire (PHQ-9). This is a multipurpose self-report instrument for screening, diagnosing, monitoring and measuring the severity of depression. Each of 9 items are scored from 0 (not at all) - 3 (nearly every day). Total scores are reported. Total scores range from 0-27. Higher scores represent more severe depression. Total scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively.

Time frame:
Measured once, during the first session which takes place on a single day.
Reported as:
Mean · scores on a scale
Depression Via PHQ-9
scores on a scaleIndividuals With StrokeNeurologically Intact Adults
Depression Via PHQ-95.11 ± 4.654.08 ± 4.70
Other pre-specifiedBerg Balance Scale

The Berg Balance Scale is a 14-item objective measure that assesses static balance and fall risk in adults. Scores range from 0-56 with higher scores representing better balance (better outcomes). Total scores are reported. Scores from 0 to 20 represent a high fall risk; scores 21 to 40 represent a medium fall risk; scores 41-56 represent a low fall risk.

Time frame:
Measured once, during the first session which takes place on a single day.
Reported as:
Mean · scores on a scale
Berg Balance Scale
scores on a scaleIndividuals With StrokeNeurologically Intact Adults
Berg Balance Scale42.00 ± 11.9252.52 ± 5.04
PrimaryStep 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

Time frame:
Aim 2: clinic before training, clinic after training, same day transfer, 1-day transfer, 3-day transfer, 1-week transfer
Reported as:
Mean · unitless
Step Length Asymmetry (Transfer)
unitlessParticipants With Stroke
Clinic Pretest (before training)0.14 ± 0.11
Clinic Posttest (immedaitely after training)0.21 ± 0.15
Home - training day follow-up0.20 ± 0.19
Home - 1-day after training0.16 ± 0.16
Home - 3-days after training0.29 ± 0.46
Home - 7 days after training0.25 ± 0.34

Adverse events

Collected over From enrollment through end of data collection (approximately 1 week for participants with stroke; approximately 2 days for participants without stroke). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Individuals With Stroke0/21 (0%)0/21 (0%)0/21 (0%)
Neurologically Intact Adults0/29 (0%)0/29 (0%)0/29 (0%)

Baseline characteristics

Data from three individuals with stroke and three individuals without stroke were excluded from analysis due to insufficient data quality. Issues included pixelated or blurry videos, failure to keep the recording device stationary, or inaccurate identification of key landmarks during pose estimation. Ultimately, the data from 43 participants were included in data analysis.

Age, Continuous
Age, Continuous(years)Individuals With StrokeNeurologically Intact AdultsTotal
Mean66.72 ± 14.7272.40 ± 8.5970.02 ± 11.74
Sex: Female, Male
Sex: Female, Male(Participants)Individuals With StrokeNeurologically Intact AdultsTotal
Female71926
Male11617
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Individuals With StrokeNeurologically Intact AdultsTotal
Hispanic or Latino101
Not Hispanic or Latino172542
Unknown or Not Reported000
08

Study locations

1 site
  • Western University of Health Sciences
    Lebanon, Oregon 97355, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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.

Supporting information: 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05454007
Lead sponsor
Western University of Health Sciences
Responsible party
Kendra Cherry-Allen (Assistant Professor, Western University of Health Sciences) — Principal investigator
First posted
Jul 12, 2022
Start date
Aug 25, 2022
Primary completion
Mar 9, 2025
Completion
Mar 9, 2025
Results posted
Jul 24, 2026
Last update
Jul 24, 2026

Study contacts

Kendra Cherry-Allen, PhD, PT, DPT
principal investigator · Western University of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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