A Novel Strategy to Decrease Fall Incidence Post-Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Fall Incidence (Number of Falls)
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Immediate Backward Walking Training
Individuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment.
Intervention: Backward Walking Training (Behavioral)
Delayed Backward Walking Training
Individuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD
Intervention: Backward Walking Training (Behavioral)
Outcomes
Primary Outcomes
Fall Incidence (Number of Falls)
Time Frame: Number of recorded falls between baseline and 1-year post-stroke
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.
Secondary Outcomes
- Stride Length(Change between baseline and 1-year post-stroke)
- Step Time(Change between baseline and 1-year post-stroke)
- Step Width(Change between baseline and 1-year post-stroke)
- Berg Balance Scale(Change between baseline and 1-year post-stroke)
- Stride Time(Change between baseline and 1-year post-stroke)
- 3-Meter Backward Walk Test(Change between baseline and 1-year post-stroke)
- Four-Step Square Test(Change between baseline and 1-year post-stroke)
- Lower-Extremity Fugl-Meyer Motor Score(Change between baseline and 1-year post-stroke)
- 10 Meter Walk Test(Change between baseline and 1-year post-stroke)
- Activities-Specific Balance Confidence Scale(Change between baseline and 1-year post-stroke)
- Step Length(Change between baseline and 1-year post-stroke)
- Functional Gait Assessment(Change between baseline and 1-year post-stroke)