A Novel Strategy to Decrease Fall Incidence Post-Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Backward Walking Training
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Gait; Postural Balance; Exercise; Accidental Falls; Kinesiology, Applied