Trial Outcomes & Findings for Tracking Post-stroke Walking Improvements From the Clinic Into the Home (NCT NCT05454007)
NCT ID: NCT05454007
Last Updated: 2026-07-24
Results Overview
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.
COMPLETED
NA
53 participants
In-clinic baseline (day 1), in-home baseline (day 1)
2026-07-24
Participant Flow
Participants were recruited from local hospitals, medical facilities, support groups, and community businesses.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
30
|
|
Overall Study
COMPLETED
|
21
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Tracking Post-stroke Walking Improvements From the Clinic Into the Home
Baseline characteristics by cohort
| Measure |
Individuals With Stroke
n=18 Participants
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.
|
Neurologically Intact Adults
n=25 Participants
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.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.72 years
STANDARD_DEVIATION 14.72 • n=9 Participants
|
72.40 years
STANDARD_DEVIATION 8.59 • n=27 Participants
|
70.02 years
STANDARD_DEVIATION 11.74 • n=267 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
26 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=9 Participants
|
25 Participants
n=27 Participants
|
42 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: In-clinic baseline (day 1), in-home baseline (day 1)Population: 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.
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.
Outcome measures
| Measure |
Individuals With Stroke
n=18 Participants
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.
|
Neurologically Intact Adults
n=25 Participants
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.
|
|---|---|---|
|
Step Length Asymmetry
Clinic Data - Baseline
|
0.12 unitless
Standard Deviation 0.11
|
0.07 unitless
Standard Deviation 0.07
|
|
Step Length Asymmetry
Home Data - Baseline
|
0.15 unitless
Standard Deviation 0.11
|
0.07 unitless
Standard Deviation 0.04
|
PRIMARY outcome
Timeframe: In-clinic baseline (day 1), in-home baseline (day 1)Population: 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.
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.
Outcome measures
| Measure |
Individuals With Stroke
n=18 Participants
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.
|
Neurologically Intact Adults
n=25 Participants
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.
|
|---|---|---|
|
Step Time Symmetry
Clinic Data - Baseline
|
0.10 unitless
Standard Deviation 0.14
|
0.05 unitless
Standard Deviation 0.07
|
|
Step Time Symmetry
Home Data - Baseline
|
0.11 unitless
Standard Deviation 0.15
|
0.04 unitless
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: In-clinic baseline (day 1), in-home baseline (day 1)Population: 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.
The speed at which a participant is walking (meters/second) Will be compared across timepoints.
Outcome measures
| Measure |
Individuals With Stroke
n=18 Participants
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.
|
Neurologically Intact Adults
n=25 Participants
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.
|
|---|---|---|
|
Self Selected Gait Speed
Clinic Data - Baseline
|
0.70 m/s
Standard Deviation 0.38
|
1.01 m/s
Standard Deviation 0.28
|
|
Self Selected Gait Speed
Home Data - Baseline
|
0.73 m/s
Standard Deviation 0.47
|
1.07 m/s
Standard Deviation 0.64
|
PRIMARY outcome
Timeframe: Aim 2: clinic before training, clinic after training, same day transfer, 1-day transfer, 3-day transfer, 1-week transferPopulation: 8 participants had full data sets and videos at all time points related to Aim 2 of this study. Only complete data sets have been analyzed at this time.
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
Outcome measures
| Measure |
Individuals With Stroke
n=8 Participants
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.
|
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.
|
|---|---|---|
|
Step Length Asymmetry (Transfer)
Clinic Pretest (before training)
|
0.14 unitless
Standard Deviation 0.11
|
—
|
|
Step Length Asymmetry (Transfer)
Clinic Posttest (immedaitely after training)
|
0.21 unitless
Standard Deviation 0.15
|
—
|
|
Step Length Asymmetry (Transfer)
Home - training day follow-up
|
0.20 unitless
Standard Deviation 0.19
|
—
|
|
Step Length Asymmetry (Transfer)
Home - 1-day after training
|
0.16 unitless
Standard Deviation 0.16
|
—
|
|
Step Length Asymmetry (Transfer)
Home - 3-days after training
|
0.29 unitless
Standard Deviation 0.46
|
—
|
|
Step Length Asymmetry (Transfer)
Home - 7 days after training
|
0.25 unitless
Standard Deviation 0.34
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured once, during the first session which takes place on a single day.Population: 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.
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.
Outcome measures
| Measure |
Individuals With Stroke
n=18 Participants
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.
|
Neurologically Intact Adults
n=25 Participants
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.
|
|---|---|---|
|
Depression Via PHQ-9
|
5.11 scores on a scale
Standard Deviation 4.65
|
4.08 scores on a scale
Standard Deviation 4.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured once, during the first session which takes place on a single day.Population: 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.
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.
Outcome measures
| Measure |
Individuals With Stroke
n=18 Participants
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.
|
Neurologically Intact Adults
n=25 Participants
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.
|
|---|---|---|
|
Berg Balance Scale
|
42.00 scores on a scale
Standard Deviation 11.92
|
52.52 scores on a scale
Standard Deviation 5.04
|
Adverse Events
Individuals With Stroke
Neurologically Intact Adults
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kendra Cherry-Allen, PhD, PT, DPT
Western University of Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place