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Completed

NCT Number: NCT05454007

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

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University of Health Sciences

Lebanon, Oregon, 97355, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent
  • epilepsy
  • orthopedic or pain conditions limiting walking
  • concurrent engagement in physical therapy or other research study.

Treatment and study plan

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.

Primary outcomes

  1. Step Length Asymmetry

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

    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.

  2. Step Time Symmetry

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

    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.

  3. Self Selected Gait Speed

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

    The speed at which a participant is walking (meters/second)

    Will be compared across timepoints.

  4. Step Length Asymmetry (Transfer)

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

Other outcomes

  1. Depression Via PHQ-9

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

    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.

  2. Berg Balance Scale

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

    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.

Sponsors and collaborators

Lead sponsor

Western University of Health Sciences

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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