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A Novel Strategy to Decrease Fall Incidence Post-Stroke

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ClinicalTrials.gov Identifier: NCT02688777
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Backward Walking Training Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Strategy to Decrease Fall Incidence Post-Stroke
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Immediate Backward Walking Training
Individuals will participate in 18 sessions of Backward Walking training immediately following baseline assessment.
Behavioral: Backward Walking Training
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.

Active Comparator: Delayed Backward Walking Training
Individuals will participate in 18 sessions of Backward Walking training at 1-year post-strokeD
Behavioral: Backward Walking Training
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.




Primary Outcome Measures :
  1. Fall incidence (number of falls) [ Time Frame: Change 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.


Secondary Outcome Measures :
  1. 10 Meter Walk Test [ Time Frame: Change between baseline and 1-year post-stroke ]
    Individuals will be given a 2 meter warm-up distance for walking, preceding the 10 meter distance and 2 meters beyond the 10 meters to continue walking. The time that it takes to traverse the 10 meters at the subject's usual pace will be recorded.

  2. 3-Meter Backward Walk test [ Time Frame: Change between baseline and 1-year post-stroke ]
    The test consists of a 1 meter warm-up distance, a timed 3 meter distance, followed by an additional 1 meter to continue walking An average of two trials will be recorded.

  3. Functional Gait Assessment [ Time Frame: Change between baseline and 1-year post-stroke ]
    A 10-item clinical gait and balance test during which participants perform the following activities: walk at normal speeds, at fast and slow speeds, with vertical and horizontal head turns, with eyes closed, over obstacles, in tandem, backward and while ascending and descending stairs.

  4. Activities-Specific Balance Confidence Scale [ Time Frame: Change between baseline and 1-year post-stroke ]
    This 16-item self-report measure is used to assess perceived efficacy (self-reported confidence) in maintaining balance while performing a number of activities common in community-dwelling older adults.

  5. Berg Balance Scale [ Time Frame: Change between baseline and 1-year post-stroke ]
    This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer.

  6. Lower-Extremity Fugl-Meyer Motor Score [ Time Frame: Change between baseline and 1-year post-stroke ]
    This tool consists of 17 items that assess motor control of the lower extremity as participants move their hip, knee and ankle in lying, sitting and standing

  7. Four-Step Square Test [ Time Frame: Change between baseline and 1-year post-stroke ]
    This clinical test of dynamic standing balance examines the ability to step over small objects, change direction and includes taking a backwards step.

  8. Stride time [ Time Frame: Change between baseline and 1-year post-stroke ]
    Stride time will be captured during forward and backward walking across a GAITRite instrumented walkway.

  9. Stride length [ Time Frame: Change between baseline and 1-year post-stroke ]
    Stride length will be captured during forward and backward walking across a GAITRite instrumented walkway.

  10. Step time [ Time Frame: Change between baseline and 1-year post-stroke ]
    Step time will be captured during forward and backward walking across a GAITRite instrumented walkway.

  11. Step length [ Time Frame: Change between baseline and 1-year post-stroke ]
    Step length will be captured during forward and backward walking across a GAITRite instrumented walkway.

  12. Step width [ Time Frame: Change between baseline and 1-year post-stroke ]
    Step width will be captured during forward and backward walking across a GAITRite instrumented walkway.

  13. Kinesiologic assessment of walking [ Time Frame: Change between baseline and 1-year post-stroke ]
    While walking, three-dimensional ground reaction forces will be acquired under each foot. Hip, knee and ankle angle data from the LE's will be acquired by placing reflective markers on the participant using a modified Helen Hayes marker set with rigid clusters on the pelvis and each thigh, shank and foot segments and recording the movement of these markers at 100 Hz using a 12 camera motion capture system.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688777


Contacts
Contact: Dorian K Rose, PhD MS BS (352) 273-8307 Dorian.Rose@va.gov
Contact: David J Clark, DSc David.Clark1@va.gov

Locations
United States, Florida
North Florida/South Georgia Veterans Health System, Gainesville, FL Recruiting
Gainesville, Florida, United States, 32608
Contact: Dorian K Rose, PhD MS BS    (352) 273-8307    Dorian.Rose@va.gov   
Contact: Janis J Daly, PhD MS    (352) 376-1611 ext 6603    Janis.Daly@va.gov   
Principal Investigator: Dorian Kay Rose, PhD MS BS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Dorian Kay Rose, PhD MS BS North Florida/South Georgia Veterans Health System, Gainesville, FL

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02688777     History of Changes
Other Study ID Numbers: N2004-R
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Rehabilitation
Gait
Postural Balance
Exercise
Accidental Falls
Kinesiology, Applied

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases