Clinical trial NCT02688777: A Novel Strategy to Decrease Fall Incidence Post-Stroke
Official title: A Novel Strategy to Decrease Fall Incidence Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Gait
Postural Balance
Exercise
Accidental Falls
Kinesiology, Applied
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-02-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fall Incidence (Number of Falls)
timeFrame: Number of recorded falls between baseline and 1-year post-stroke
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: Change between baseline and 1-year post-stroke
measure: 3-Meter Backward Walk Test
timeFrame: Change between baseline and 1-year post-stroke
measure: Functional Gait Assessment
timeFrame: Change between baseline and 1-year post-stroke
measure: Activities-Specific Balance Confidence Scale
timeFrame: Change between baseline and 1-year post-stroke
measure: Berg Balance Scale
timeFrame: Change between baseline and 1-year post-stroke
measure: Lower-Extremity Fugl-Meyer Motor Score
timeFrame: Change between baseline and 1-year post-stroke
measure: Four-Step Square Test
timeFrame: Change between baseline and 1-year post-stroke
measure: Stride Time
timeFrame: Change between baseline and 1-year post-stroke
measure: Stride Length
timeFrame: Change between baseline and 1-year post-stroke
measure: Step Time
timeFrame: Change between baseline and 1-year post-stroke
measure: Step Length
timeFrame: Change between baseline and 1-year post-stroke
measure: Step Width
timeFrame: Change between baseline and 1-year post-stroke
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System, Gainesville, FL
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL
name: Dorian Kay Rose, PhD MS BS
role: PRINCIPAL_INVESTIGATOR
References: