An interventional study of Error reduction and Error augmentation in Stroke, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.
Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 54 is close to the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →VA Office of Research and Development is the lead sponsor of 1,768 studies on the registry; 393 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 183 (87%) have results posted.
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Exclusion Criteria:
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Behavioral: Error reduction
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Behavioral: Error augmentation
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Behavioral: Activity matched control
During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Functional Gait Assessment (Change From Baseline)
A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Activities-specific Balance Confidence Scale (Change From Baseline)
A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
10-meter Walk Test (Change From Baseline)
A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Fall Incidence
Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component
Time frame: 6 months (during 12 week follow-up period)
Fear of Falling
Self-report statement of whether a participant has a fear of falling
Time frame: 6 months (at completion of 12-week Follow-up period)
Participants were recruited and enrolled between February 2017 and October 2019 from a database housed at the Medical University of South Carolina. Individuals in this database had previously experienced a stroke, and had agreed to be contacted for participation in research studies.
| Milestone | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| Started | 18 | 18 | 18 |
| Received allocated intervention | 15 | 17 | 14 |
| Completed | 14 | 17 | 13 |
| Not completed | 4 | 1 | 5 |
| Withdrew: Medical reason unrelated to study participation | 1 | 0 | 3 |
| Withdrew: Research shutdown due to pandemic | 2 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 |
A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
| Correlation coefficient | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| 4-week assessment | -0.02 ± 0.22 | 0.12 ± 0.20 | -0.04 ± 0.14 |
| 8-week assessment | 0.05 ± 0.15 | 0.11 ± 0.20 | -0.02 ± 0.16 |
| 12-week assessment | 0 ± 0.08 | 0.08 ± 0.18 | 0.01 ± 0.12 |
| Follow-up assessment (after 12 weeks) | -0.01 ± 0.16 | 0.11 ± 0.18 | 0 ± 0.14 |
A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
| score on a scale | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| 4-week assessment | 0.1 ± 1.8 | 1.5 ± 2.3 | 1.6 ± 2.1 |
| 8-week assessment | 0.8 ± 2.3 | 1.9 ± 2.7 | 2.5 ± 2.8 |
| 12-week assessment | 1.5 ± 2.5 | 2.9 ± 1.9 | 2.1 ± 1.8 |
| Follow-up assessment (after 12 weeks) | 1.0 ± 2.5 | 2.2 ± 2.5 | 1.9 ± 3.5 |
A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
| score on a scale | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| 4-week assessment | 2.2 ± 11.2 | -0.6 ± 6.9 | 3.7 ± 10.3 |
| 8-week assessment | 2.5 ± 12.9 | -1.2 ± 4.9 | 4.1 ± 16.2 |
| 12-week assessment | 6.1 ± 16.4 | 2.8 ± 6.8 | 5.4 ± 12.5 |
| Follow-up assessment (after 12 weeks) | 8.1 ± 14.7 | 4.6 ± 7.9 | 3.7 ± 22.8 |
A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).
| meters per second | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| 4-week assessment | 0.01 ± 0.08 | 0.03 ± 0.08 | 0.03 ± 0.08 |
| 8-week assessment | 0.02 ± 0.10 | 0.04 ± 0.07 | 0.04 ± 0.10 |
| 12-week assessment | 0.05 ± 0.14 | 0.02 ± 0.08 | 0.06 ± 0.10 |
| Follow-up assessment (after 12 weeks | 0.01 ± 0.15 | 0.01 ± 0.11 | 0.01 ± 0.11 |
Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component
| Falls per participant | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| Fall Incidence | 0.50 ± 0.20 | 0.29 ± 0.14 | 0.62 ± 0.23 |
Self-report statement of whether a participant has a fear of falling
| Participants | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| Fear of Falling | 4 | 5 | 4 |
Collected over Adverse event data were collected over a three-year period, corresponding from the time when the first participant was enrolled into the intervention to the time when the overall intervention ended.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Error Reduction | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Error Augmentation | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Activity Matched Control | 0/18 (0%) | 1/18 (5.6%) | 0/18 (0%) |
| Event | Error Reduction | Error Augmentation | Activity Matched Control |
|---|---|---|---|
| StrokeVascular disorders | 0/18 | 0/18 | 1/18 |
| Age, Continuous(years) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Mean | 64 ± 13 | 57 ± 13 | 57 ± 14 | 59 ± 14 |
| Sex: Female, Male(Participants) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Female | 9 | 6 | 9 | 24 |
| Male | 9 | 12 | 9 | 30 |
| Ethnicity (NIH/OMB)(Participants) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 18 | 18 | 18 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 6 | 7 | 8 | 21 |
| White | 12 | 10 | 10 | 32 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Affected leg(Participants) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Left leg | 10 | 9 | 10 | 29 |
| Right leg | 8 | 9 | 8 | 25 |
| Time since stroke(months) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Mean | 53 ± 48 | 53 ± 46 | 56 ± 57 | 54 ± 50 |
| Height(inches) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Mean | 66 ± 4 | 68 ± 4 | 67 ± 4 | 67 ± 4 |
| Weight(pounds) | Error Reduction | Error Augmentation | Activity Matched Control | Total |
|---|---|---|---|---|
| Mean | 187 ± 49 | 189 ± 44 | 181 ± 39 | 186 ± 43 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified, anonymized data sets will be available to other investigators or members of the public upon request. These data sets will be made available upon completion of data collection, processing, and initial statistical analyses. The data sets will include physiological measures related to functional mobility, as well as the results of clinical tests.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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