A Novel Strategy to Decrease Fall Incidence Post-Stroke — BLAST  

Stroke Clinical Trial

Official title: A Novel Strategy to Decrease Fall Incidence Post-Stroke

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT02688777
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Completion date: February 11, 2022