Stroke
Conditions
Keywords
stroke, rehabilitation, gait
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALError reduction
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.
BEHAVIORALError augmentation
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.
BEHAVIORALActivity matched control
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 21 years old * Experience of a stroke 6 months prior to participation * Preferred overground gait speed of at least 0.2 m/s * Ability to walk at self-selected speed for 3 minutes without a cane or walker * Provision of informed consent.
Exclusion criteria
* Resting heart rate above 110 beats/min * Resting blood pressure higher than 200/110 mm Hg * History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living * Preexisting neurological disorders or dementia * History of major head trauma * Legal blindness or severe visual impairment * Life expectancy \<1 yr; 8) * History of deep vein thrombosis or pulmonary embolism within 6 months * Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions * Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Gait Assessment (Change From Baseline) | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks | 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). |
| Activities-specific Balance Confidence Scale (Change From Baseline) | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks | 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). |
| 10-meter Walk Test (Change From Baseline) | baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks | 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). |
| Fall Incidence | 6 months (during 12 week follow-up period) | 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 |
| Fear of Falling | 6 months (at completion of 12-week Follow-up period) | Self-report statement of whether a participant has a fear of falling |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 93 participants who were assessed for eligibility, 54 met the study's inclusion criteria and were interested in participating in the intervention. These 54 participants were randomized to one of the three study arms.
Participants by arm
| Arm | Count |
|---|---|
| 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 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.
Error reduction: 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. | 18 |
| 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 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.
Error augmentation: 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. | 18 |
| Activity Matched Control 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.
Activity matched control: 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. | 18 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Medical reason unrelated to study participation | 1 | 0 | 3 |
| Overall Study | Research shutdown due to pandemic | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Activity Matched Control | Total | Error Augmentation | Error Reduction |
|---|---|---|---|---|
| Activities-specific Balance Confidence scale | 69.3 Score on a scale STANDARD_DEVIATION 15.3 | 68.3 Score on a scale STANDARD_DEVIATION 16.6 | 69.8 Score on a scale STANDARD_DEVIATION 12.4 | 65.7 Score on a scale STANDARD_DEVIATION 22.2 |
| Affected leg Left leg | 10 Participants | 29 Participants | 9 Participants | 10 Participants |
| Affected leg Right leg | 8 Participants | 25 Participants | 9 Participants | 8 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 14 | 59 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 13 | 64 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 54 Participants | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fall incidence (self reported over previous year) | 7 Participants | 20 Participants | 7 Participants | 6 Participants |
| Fear of falling (self-reported) | 4 Participants | 16 Participants | 7 Participants | 5 Participants |
| Functional Gait Assessment | 13.5 Score on a scale STANDARD_DEVIATION 5 | 14.3 Score on a scale STANDARD_DEVIATION 4.6 | 13.8 Score on a scale STANDARD_DEVIATION 5.2 | 15.5 Score on a scale STANDARD_DEVIATION 3.2 |
| Height | 67 inches STANDARD_DEVIATION 4 | 67 inches STANDARD_DEVIATION 4 | 68 inches STANDARD_DEVIATION 4 | 66 inches STANDARD_DEVIATION 4 |
| Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait | 0.51 Correlation Coefficient STANDARD_DEVIATION 0.1 | 0.43 Correlation Coefficient STANDARD_DEVIATION 0.16 | 0.34 Correlation Coefficient STANDARD_DEVIATION 0.19 | 0.44 Correlation Coefficient STANDARD_DEVIATION 0.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 21 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 32 Participants | 10 Participants | 12 Participants |
| Sex: Female, Male Female | 9 Participants | 24 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 30 Participants | 12 Participants | 9 Participants |
| Time since stroke | 56 months STANDARD_DEVIATION 57 | 54 months STANDARD_DEVIATION 50 | 53 months STANDARD_DEVIATION 46 | 53 months STANDARD_DEVIATION 48 |
| Walking speed (10-meter walk test) | 0.78 meters per second STANDARD_DEVIATION 0.31 | 0.78 meters per second STANDARD_DEVIATION 0.28 | 0.73 meters per second STANDARD_DEVIATION 0.31 | 0.84 meters per second STANDARD_DEVIATION 0.21 |
| Weight | 181 pounds STANDARD_DEVIATION 39 | 186 pounds STANDARD_DEVIATION 43 | 189 pounds STANDARD_DEVIATION 44 | 187 pounds STANDARD_DEVIATION 49 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 1 / 18 |
Outcome results
Primary
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
Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Error Reduction | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 4-week assessment | -0.02 Correlation coefficient | Standard Deviation 0.22 |
| Error Reduction | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 8-week assessment | 0.05 Correlation coefficient | Standard Deviation 0.15 |
| Error Reduction | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 12-week assessment | 0 Correlation coefficient | Standard Deviation 0.08 |
| Error Reduction | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | Follow-up assessment (after 12 weeks) | -0.01 Correlation coefficient | Standard Deviation 0.16 |
| Error Augmentation | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | Follow-up assessment (after 12 weeks) | 0.11 Correlation coefficient | Standard Deviation 0.18 |
| Error Augmentation | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 4-week assessment | 0.12 Correlation coefficient | Standard Deviation 0.2 |
| Error Augmentation | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 12-week assessment | 0.08 Correlation coefficient | Standard Deviation 0.18 |
| Error Augmentation | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 8-week assessment | 0.11 Correlation coefficient | Standard Deviation 0.2 |
| Activity Matched Control | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | Follow-up assessment (after 12 weeks) | 0 Correlation coefficient | Standard Deviation 0.14 |
| Activity Matched Control | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 8-week assessment | -0.02 Correlation coefficient | Standard Deviation 0.16 |
| Activity Matched Control | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 12-week assessment | 0.01 Correlation coefficient | Standard Deviation 0.12 |
| Activity Matched Control | Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline) | 4-week assessment | -0.04 Correlation coefficient | Standard Deviation 0.14 |
p-value: 0.047ANOVA
Secondary
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
Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Error Reduction | 10-meter Walk Test (Change From Baseline) | 12-week assessment | 0.05 meters per second | Standard Deviation 0.14 |
| Error Reduction | 10-meter Walk Test (Change From Baseline) | Follow-up assessment (after 12 weeks | 0.01 meters per second | Standard Deviation 0.15 |
| Error Reduction | 10-meter Walk Test (Change From Baseline) | 4-week assessment | 0.01 meters per second | Standard Deviation 0.08 |
| Error Reduction | 10-meter Walk Test (Change From Baseline) | 8-week assessment | 0.02 meters per second | Standard Deviation 0.1 |
| Error Augmentation | 10-meter Walk Test (Change From Baseline) | 12-week assessment | 0.02 meters per second | Standard Deviation 0.08 |
| Error Augmentation | 10-meter Walk Test (Change From Baseline) | 8-week assessment | 0.04 meters per second | Standard Deviation 0.07 |
| Error Augmentation | 10-meter Walk Test (Change From Baseline) | Follow-up assessment (after 12 weeks | 0.01 meters per second | Standard Deviation 0.11 |
| Error Augmentation | 10-meter Walk Test (Change From Baseline) | 4-week assessment | 0.03 meters per second | Standard Deviation 0.08 |
| Activity Matched Control | 10-meter Walk Test (Change From Baseline) | Follow-up assessment (after 12 weeks | 0.01 meters per second | Standard Deviation 0.11 |
| Activity Matched Control | 10-meter Walk Test (Change From Baseline) | 4-week assessment | 0.03 meters per second | Standard Deviation 0.08 |
| Activity Matched Control | 10-meter Walk Test (Change From Baseline) | 8-week assessment | 0.04 meters per second | Standard Deviation 0.1 |
| Activity Matched Control | 10-meter Walk Test (Change From Baseline) | 12-week assessment | 0.06 meters per second | Standard Deviation 0.1 |
p-value: 0.92ANOVA
Secondary
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
Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Error Reduction | Activities-specific Balance Confidence Scale (Change From Baseline) | 4-week assessment | 2.2 score on a scale | Standard Deviation 11.2 |
| Error Reduction | Activities-specific Balance Confidence Scale (Change From Baseline) | 8-week assessment | 2.5 score on a scale | Standard Deviation 12.9 |
| Error Reduction | Activities-specific Balance Confidence Scale (Change From Baseline) | 12-week assessment | 6.1 score on a scale | Standard Deviation 16.4 |
| Error Reduction | Activities-specific Balance Confidence Scale (Change From Baseline) | Follow-up assessment (after 12 weeks) | 8.1 score on a scale | Standard Deviation 14.7 |
| Error Augmentation | Activities-specific Balance Confidence Scale (Change From Baseline) | Follow-up assessment (after 12 weeks) | 4.6 score on a scale | Standard Deviation 7.9 |
| Error Augmentation | Activities-specific Balance Confidence Scale (Change From Baseline) | 8-week assessment | -1.2 score on a scale | Standard Deviation 4.9 |
| Error Augmentation | Activities-specific Balance Confidence Scale (Change From Baseline) | 4-week assessment | -0.6 score on a scale | Standard Deviation 6.9 |
| Error Augmentation | Activities-specific Balance Confidence Scale (Change From Baseline) | 12-week assessment | 2.8 score on a scale | Standard Deviation 6.8 |
| Activity Matched Control | Activities-specific Balance Confidence Scale (Change From Baseline) | 4-week assessment | 3.7 score on a scale | Standard Deviation 10.3 |
| Activity Matched Control | Activities-specific Balance Confidence Scale (Change From Baseline) | 8-week assessment | 4.1 score on a scale | Standard Deviation 16.2 |
| Activity Matched Control | Activities-specific Balance Confidence Scale (Change From Baseline) | 12-week assessment | 5.4 score on a scale | Standard Deviation 12.5 |
| Activity Matched Control | Activities-specific Balance Confidence Scale (Change From Baseline) | Follow-up assessment (after 12 weeks) | 3.7 score on a scale | Standard Deviation 22.8 |
p-value: 0.64ANOVA
Secondary
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)
Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Error Reduction | Fall Incidence | 0.50 Falls per participant | Standard Error 0.2 |
| Error Augmentation | Fall Incidence | 0.29 Falls per participant | Standard Error 0.14 |
| Activity Matched Control | Fall Incidence | 0.62 Falls per participant | Standard Error 0.23 |
p-value: >=0.22Mixed Models Analysis
Secondary
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)
Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Error Reduction | Fear of Falling | 4 Participants |
| Error Augmentation | Fear of Falling | 5 Participants |
| Activity Matched Control | Fear of Falling | 4 Participants |
p-value: 0.99Chi-squared
Secondary
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
Population: The total of 44 participants analyzed corresponds to the participants who completed the intervention and follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Error Reduction | Functional Gait Assessment (Change From Baseline) | 4-week assessment | 0.1 score on a scale | Standard Deviation 1.8 |
| Error Reduction | Functional Gait Assessment (Change From Baseline) | 8-week assessment | 0.8 score on a scale | Standard Deviation 2.3 |
| Error Reduction | Functional Gait Assessment (Change From Baseline) | 12-week assessment | 1.5 score on a scale | Standard Deviation 2.5 |
| Error Reduction | Functional Gait Assessment (Change From Baseline) | Follow-up assessment (after 12 weeks) | 1.0 score on a scale | Standard Deviation 2.5 |
| Error Augmentation | Functional Gait Assessment (Change From Baseline) | Follow-up assessment (after 12 weeks) | 2.2 score on a scale | Standard Deviation 2.5 |
| Error Augmentation | Functional Gait Assessment (Change From Baseline) | 4-week assessment | 1.5 score on a scale | Standard Deviation 2.3 |
| Error Augmentation | Functional Gait Assessment (Change From Baseline) | 12-week assessment | 2.9 score on a scale | Standard Deviation 1.9 |
| Error Augmentation | Functional Gait Assessment (Change From Baseline) | 8-week assessment | 1.9 score on a scale | Standard Deviation 2.7 |
| Activity Matched Control | Functional Gait Assessment (Change From Baseline) | Follow-up assessment (after 12 weeks) | 1.9 score on a scale | Standard Deviation 3.5 |
| Activity Matched Control | Functional Gait Assessment (Change From Baseline) | 8-week assessment | 2.5 score on a scale | Standard Deviation 2.8 |
| Activity Matched Control | Functional Gait Assessment (Change From Baseline) | 12-week assessment | 2.1 score on a scale | Standard Deviation 1.8 |
| Activity Matched Control | Functional Gait Assessment (Change From Baseline) | 4-week assessment | 1.6 score on a scale | Standard Deviation 2.1 |
p-value: 0.16ANOVA