Tracking Post-stroke Walking Improvements From the Clinic Into the Home
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Lebanon, Oregon, United States, 97355
- Western University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Step Length Asymmetry
Time Frame: In-clinic baseline (day 1), in-home baseline (day 1)
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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)
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Step Time Symmetry
Time Frame: In-clinic baseline (day 1), in-home baseline (day 1)
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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)
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Self Selected Gait Speed
Time Frame: In-clinic baseline (day 1), in-home baseline (day 1)
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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)
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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
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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
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Aim 2: clinic before training, clinic after training, same day transfer, 1-day transfer, 3-day transfer, 1-week transfer
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression Via PHQ-9
Time Frame: Measured once, during the first session which takes place on a single day.
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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. |
Measured once, during the first session which takes place on a single day.
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Berg Balance Scale
Time Frame: Measured once, during the first session which takes place on a single day.
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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. |
Measured once, during the first session which takes place on a single day.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kendra Cherry-Allen, PhD, PT, DPT, Western University of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P22/IRB/029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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