A Novel Strategy to Decrease Fall Incidence Post-Stroke

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Novel Strategy to Decrease Fall Incidence Post-Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Backward Walking Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Berg Balance Scale < 42 Self-selected 10 meter gait speed < 0.8 m/s Diagnosis of unilateral stroke > 2 months < 4 months post-stroke Able to ambulate at least 10 feet with maximum 1 person assist Medically stable 18-85 years of age Physician approval for patient participation Exclusion Criteria: Presence of neurological condition other than stroke Serious cardiac conditions hospitalization for myocardial infarction or heart surgery within 3 months history of congestive heart failure documented serious and unstable cardiac arrhythmias hypertrophic cardiomyopathy severe aortic stenosis angina or dyspnea at rest or during activities of daily living Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity knee flexion contracture of -10 knee flexion Range Of Motion < 90 hip flexion contracture > 25 ankle plantar flexion contracture > 15 Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg Pain upon ambulation Receiving physical therapy services for mobility and/or gait Living in a skilled nursing facility Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters History of serious chronic obstructive pulmonary disease or oxygen independence Non-healing ulcers on the lower extremity Uncontrollable diabetes with recent weight loss, diabetic coma or frequent insulin reactions On renal dialysis or presence of end stage liver disease Pulmonary embolism within previous 6 months History of major head trauma History of sustained alcoholism or drug abuse in the last six months Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation Current enrollment in a clinical trial to enhance stroke motor recovery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Backward Walking Training<br>Individuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment. | Behavioral: Backward Walking Training<br>* 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.<br>|
| Active Comparator: Delayed Backward Walking Training<br>Individuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD | Behavioral: Backward Walking Training<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Number of recorded falls between baseline and 1-year post-stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | Change between baseline and 1-year post-stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation, Gait, Postural Balance, Exercise, Accidental Falls, Kinesiology, Applied