An interventional study of Backward Walking Training in Stroke, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Contributing to these costs is the incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to an increased incidence of fractures, depression, and mortality. New strategies are needed to help Veterans post-stroke regain their ability to safely walk without increasing their risk of falling as well as readily identify those who are a fall risk. This study addresses both of these needs as it will 1) investigate a new treatment approach, backward walking training, to determine if it will decrease fall incidence in the first year post-stroke and 2) determine if backward walking speed early after a stroke can identify those that are at risk for future falls.
Approximately 15,000 Veterans are hospitalized for stroke each year. Persistent walking and balance deficits contribute to long-term disability and a high incidence of falls. Falls are a common and costly complication of stroke; between 40% and 70% of affected individuals fall within the first year. Falls lead to fear of falling, limitations in self-care and increased dependence. Of greater concern, they lead to serious adverse events, including fractures, depression and mortality. A primary goal of stroke rehabilitation is to improve mobility despite persistent motor, balance and visual-spatial deficits. However, this goal has a down side since it increases fall risks. Here, the investigators propose a novel therapeutic strategy to improve ambulation while decreasing the risk of falls: Backward Walking Training (BWTraining).
The investigators' central hypothesis is that a 6-week BWTraining program at 2-months post-stroke is superior to standard care in reducing falls within the 1st year post-stroke. Identification of those at risk for falling is a necessary component of post-stroke rehabilitation to implement pro-active measures to decrease risk once individuals rejoin community living. Recent research in a cohort of elderly adults determined that maximal Backward Walking Speed (BWSpeed) (not forward) identified individuals that had experienced a fall in the previous six months,6 suggesting that BWSpeed could be a simple, inexpensive screening tool to identify individuals at risk of falling. With a randomized, blinded design, the investigators propose to prospectively assess the value of BWSpeed as a tool to predict future falls.
A notable post-stroke conundrum is that increased mobility may increase fall risk.5 On the other hand, limiting mobility leads to a multitude of inactivity-associated deficits, including recurrent stroke.
To date, no intervention has demonstrated efficacy for improving walking while minimizing fall risk. BWTraining may be a simple and effective intervention to achieve both goals. In the investigators' recent randomized controlled pilot trial (RCT), individuals with sub-acute stroke who participated in a BWTraining demonstrated 3-fold improvement in backward and forward walking speed and fall self-efficacy. Further, BWTraining caused 75% greater improvement in balance versus those in a dose-matched balance training group. At the 3-month follow-up assessment, BWSpeed of the BWTraining group averaged 0.63 m/s, exceeding the threshold for fall risk in elderly adults.
Given the success of the investigators' pilot intervention, a larger and more rigorous trial is needed to demonstrate reduced fall incidence over an extended follow-up period. The investigators designed this RCT to address three specific aims:
Aim #1: Test the hypothesis that 1-year fall incidence is decreased for participants randomized to BWTraining administered at 2-months post-stroke (versus usual care comparison group).
Hypothesis #1a: BWTraining at 2-months post-stroke reduces the number of falls over the next year.
Hypothesis #1b: BWTraining at 2-months post-stroke increases gait speed, improves balance and increases balance confidence over the next year.
Aim #2: Test the hypothesis that BWTraining at 2 months (immediate) vs. 1-year (delayed) post-stroke is more effective at improving BWSpeed.
Hypothesis #2a: BWSpeed improvement from 2- to 14-months post-stroke is greater when BWTraining is delivered at 2 months versus 1 year post-stroke.
Hypothesis #2b: Improvements in forward gait speed, Functional Gait Assessment and Activities-Balance Confidence Scale from 2- to 14-months post-stroke are greater when BWTraining is delivered at 2 months versus 1 year post-stroke.
Aim #3: This exploratory aim will test the hypothesis that BWSpeed at 2-months post-stroke is a significant predictor of fall incidence over the next year 1 year period, after adjusting for other covariates.
Hypothesis #3: BWSpeed at 2-months will be a significant predictor of fall incidence during the first year post-stroke, after adjusting for other covariates.
This study is significant since it concerns a novel strategy to improve ambulation while minimizing the risk of falling after a stroke. BWTraining is highly novel, is easy to administer and exciting preliminary data suggest that is has major potential as a therapeutic tool. In addition, the investigators will determine the potential of BWSpeed (a simple, clinically relevant screening tool) to identify those at risk for future falls.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 62 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
Serious cardiac conditions
Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity
Individuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment.
Behavioral: Backward Walking Training
Individuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD
Behavioral: Backward Walking Training
Backward Walking Training will occur both on a treadmill and overground. In brief, BWTraining will consist of 20-30 minutes of step training with a Body Weight Support and Treadmill system (BWST), rest periods provided as warranted, with manual assistance provided by trainers, followed by 15 minutes of overground gait training. A 20-30 min period of actual stepping is the goal for the intervention sessions on the treadmill with rest periods as needed. Each training session may last up to 1 hour and 30 minutes including time for warm-up, stretching, and cool down. Participants will be fitted with a harness around their hips and torso, which will be attached to an overhead support system directly above the treadmill. From a stationary position, the treadmill belt will gradually be increased in speed with intervention trainers assisting participant to step backward with their paretic leg, their non-paretic leg (if needed) and at the hips for weight-shift.
Fall Incidence (Number of Falls)
Fall incidence will be monitored using the international standards for defining and reporting falls,60 including the following definition for a fall: "A person has a fall if they end up on the ground or floor when they did not expect to. Most often a fall starts while a person is on their feet, but a fall could also start from a chair or bed. If a person ends up on the ground, either on their knees, their belly, their side, their bottom, or their back, they have had a fall." This explanation will be provided to participants and caregivers and printed on monthly calendars issued at randomization. The number of falls will be recorded on a monthly basis and then added across months to determine the number of recorded falls between baseline and 1-year post-stroke.
Time frame: Number of recorded falls between baseline and 1-year post-stroke
10 Meter Walk Test
Individuals will be given a 2 meter warm-up distance for walking, preceding the 10 meter distance and 2 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
Time frame: Change between baseline and 1-year post-stroke
3-Meter Backward Walk Test
The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking An average of two trials will be recorded.
Time frame: Change between baseline and 1-year post-stroke
Functional Gait Assessment
A 10-item clinical gait and balance test during which participants perform the following activities: walk at normal speeds, at fast and slow speeds, with vertical and horizontal head turns, with eyes closed, over obstacles, in tandem, backward and while ascending and descending stairs. Minimum value: 0 Maximum value: 40 Higher score = better outcome
Time frame: Change between baseline and 1-year post-stroke
Activities-Specific Balance Confidence Scale
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. Minimum value: 0% Maximum value: 100% Higher score = better outcome
Time frame: Change between baseline and 1-year post-stroke
Berg Balance Scale
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. Minimum Value: 0 Maximum Value 56 Higher score = better outcome
Time frame: Change between baseline and 1-year post-stroke
Lower-Extremity Fugl-Meyer Motor Score
This tool consists of 17 items that assess motor control of the lower extremity as participants move their hip, knee and ankle in lying, sitting and standing. Minimum score=0 Maximum score = 34 Higher score = better outcome
Time frame: Change between baseline and 1-year post-stroke
Four-Step Square Test
This clinical test of dynamic standing balance examines the ability to step over small objects, change direction and includes taking a backwards step.
Time frame: Change between baseline and 1-year post-stroke
Stride Time
Stride time will be captured during forward and backward walking across a pressure-sensitive instrumented walkway.
Time frame: Change between baseline and 1-year post-stroke
Stride Length
Stride length will be captured during forward and backward walking across a GAITRite instrumented walkway.
Time frame: Change between baseline and 1-year post-stroke
Step Time
Step time will be captured during forward and backward walking across a GAITRite instrumented walkway.
Time frame: Change between baseline and 1-year post-stroke
Step Length
Step length will be captured during forward and backward walking across a GAITRite instrumented walkway.
Time frame: Change between baseline and 1-year post-stroke
Step Width
Step width will be captured during forward and backward walking across a GAITRite instrumented walkway.
Time frame: Change between baseline and 1-year post-stroke
| Milestone | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Started | 32 | 30 |
| Completed | 25 | 19 |
| Not completed | 7 | 11 |
Fall incidence will be monitored using the international standards for defining and reporting falls,60 including the following definition for a fall: "A person has a fall if they end up on the ground or floor when they did not expect to. Most often a fall starts while a person is on their feet, but a fall could also start from a chair or bed. If a person ends up on the ground, either on their knees, their belly, their side, their bottom, or their back, they have had a fall." This explanation will be provided to participants and caregivers and printed on monthly calendars issued at randomization. The number of falls will be recorded on a monthly basis and then added across months to determine the number of recorded falls between baseline and 1-year post-stroke.
| number of falls | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Fall Incidence (Number of Falls) | 88 | 56 |
Individuals will be given a 2 meter warm-up distance for walking, preceding the 10 meter distance and 2 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.
| meters/second | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| 10 Meter Walk Test | 0.17 ± 0.03 | 0.22 ± 0.04 |
The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking An average of two trials will be recorded.
| meters/second | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| 3-Meter Backward Walk Test | 0.13 ± 0.02 | 0.19 ± 0.03 |
A 10-item clinical gait and balance test during which participants perform the following activities: walk at normal speeds, at fast and slow speeds, with vertical and horizontal head turns, with eyes closed, over obstacles, in tandem, backward and while ascending and descending stairs. Minimum value: 0 Maximum value: 40 Higher score = better outcome
| score on a scale | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Functional Gait Assessment | 4.8 ± 0.84 | 5.6 ± 1.1 |
This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults. Minimum value: 0% Maximum value: 100% Higher score = better outcome
| percentage of confidence | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Activities-Specific Balance Confidence Scale | 15.9 ± 3.4 | 21.6 ± 3.5 |
This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. Minimum Value: 0 Maximum Value 56 Higher score = better outcome
| score on a scale | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Berg Balance Scale | 10.1 ± 1.8 | 10.4 ± 0.4 |
This tool consists of 17 items that assess motor control of the lower extremity as participants move their hip, knee and ankle in lying, sitting and standing. Minimum score=0 Maximum score = 34 Higher score = better outcome
| score on a scale | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Lower-Extremity Fugl-Meyer Motor Score | 2.6 ± 0.7 | 4.8 ± 0.9 |
This clinical test of dynamic standing balance examines the ability to step over small objects, change direction and includes taking a backwards step.
| seconds | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Four-Step Square Test | 20.54 ± 6.89 | 34.49 ± 10.96 |
Stride time will be captured during forward and backward walking across a pressure-sensitive instrumented walkway.
| seconds | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Stride Time | 0.30 ± 0.03 | 0.26 ± 0.05 |
Stride length will be captured during forward and backward walking across a GAITRite instrumented walkway.
| centimeters | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Stride Length | 5.1 ± 0.08 | 6.1 ± 0.09 |
Step time will be captured during forward and backward walking across a GAITRite instrumented walkway.
| seconds | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Step Time | .116 ± 0.02 | .195 ± 0.03 |
Step length will be captured during forward and backward walking across a GAITRite instrumented walkway.
| centimeters | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Step Length | 3.4 ± 1.2 | 5.0 ± 1.9 |
Step width will be captured during forward and backward walking across a GAITRite instrumented walkway.
| centimeters | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Step Width | 1.2 ± 0.06 | 2.2 ± 0.07 |
Collected over Three years - over the course of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Backward Walking Training | 0/32 (0%) | 8/32 (25%) | 21/32 (65.6%) |
| Delayed Backward Walking Training | 1/30 (3.3%) | 10/30 (33.3%) | 18/30 (60%) |
| Event | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Inpatient HospitalizationGeneral disorders | 8/32 | 10/30 |
| Event | Immediate Backward Walking Training | Delayed Backward Walking Training |
|---|---|---|
| Fall without injuryGeneral disorders | 21/32 | 18/30 |
| Age, Categorical(Participants) | Immediate Backward Walking Training | Delayed Backward Walking Training | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 20 | 44 |
| >=65 years | 8 | 10 | 18 |
| Age, Continuous(years) | Immediate Backward Walking Training | Delayed Backward Walking Training | Total |
|---|---|---|---|
| Mean | 59.3 ± 10.8 | 57.8 ± 14.5 | 58.5 ± 12.7 |
| Sex: Female, Male(Participants) | Immediate Backward Walking Training | Delayed Backward Walking Training | Total |
|---|---|---|---|
| Female | 11 | 10 | 21 |
| Male | 21 | 20 | 41 |
| Race (NIH/OMB)(Participants) | Immediate Backward Walking Training | Delayed Backward Walking Training | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 11 | 23 |
| White | 16 | 18 | 34 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Immediate Backward Walking Training | Delayed Backward Walking Training | Total |
|---|---|---|---|
| United States | 32 | 30 | 62 |
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