A Novel Strategy to Decrease Fall Incidence Post-Stroke
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 11/24/2018 |
| Start Date: | August 14, 2017 |
| End Date: | May 31, 2020 |
| Contact: | Dorian K Rose, PhD MS BS |
| Email: | Dorian.Rose@va.gov |
| Phone: | (352) 273-8307 |
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.
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.
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.
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.
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 ROM < 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
We found this trial at
1
site
Gainesville, Florida 32608
Principal Investigator: Dorian Kay Rose, PhD MS BS
Phone: (352) 273-8307
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