Stroke Clinical Trial
— BLASTOfficial title:
A Novel Strategy to Decrease Fall Incidence Post-Stroke
Verified date | November 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | February 11, 2022 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | North Florida/South Georgia Veterans Health System, Gainesville, FL | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fall Incidence (Number of Falls) | 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. The number of falls will be recorded on a monthly basis and then added across months to determine the number of recorded falls between baseline and 1-year post-stroke. | Number of recorded falls between baseline and 1-year post-stroke | |
Secondary | 10 Meter Walk Test | 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. | Change between baseline and 1-year post-stroke | |
Secondary | 3-Meter Backward Walk Test | 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. | Change between baseline and 1-year post-stroke | |
Secondary | Functional Gait Assessment | 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. Minimum value: 0 Maximum value: 40 Higher score = better outcome |
Change between baseline and 1-year post-stroke | |
Secondary | Activities-Specific Balance Confidence Scale | 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. Minimum value: 0% Maximum value: 100% Higher score = better outcome |
Change between baseline and 1-year post-stroke | |
Secondary | Berg Balance Scale | This tool consists of 14 items that assesses static and dynamic standing balance, ability to sit, stand up and transfer. Minimum Value: 0 Maximum Value 56 Higher score = better outcome |
Change between baseline and 1-year post-stroke | |
Secondary | Lower-Extremity Fugl-Meyer Motor Score | 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. Minimum score=0 Maximum score = 34 Higher score = better outcome |
Change between baseline and 1-year post-stroke | |
Secondary | Four-Step Square Test | This clinical test of dynamic standing balance examines the ability to step over small objects, change direction and includes taking a backwards step. | Change between baseline and 1-year post-stroke | |
Secondary | Stride Time | Stride time will be captured during forward and backward walking across a pressure-sensitive instrumented walkway. | Change between baseline and 1-year post-stroke | |
Secondary | Stride Length | Stride length will be captured during forward and backward walking across a GAITRite instrumented walkway. | Change between baseline and 1-year post-stroke | |
Secondary | Step Time | Step time will be captured during forward and backward walking across a GAITRite instrumented walkway. | Change between baseline and 1-year post-stroke | |
Secondary | Step Length | Step length will be captured during forward and backward walking across a GAITRite instrumented walkway. | Change between baseline and 1-year post-stroke | |
Secondary | Step Width | Step width will be captured during forward and backward walking across a GAITRite instrumented walkway. | Change between baseline and 1-year post-stroke |
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