An observational study in Stroke, Acute and Gait, Hemiplegic, sponsored by University of Vermont. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by University of Vermont · Observational
Prediction of walking recovery after stroke can inform patient-centered care and support discharge planning. The accuracy of current prediction models is limited, however, due to small study designs and narrow predictors assessed. The investigators propose a comprehensive evaluation of a novel combination of biomarkers to improve prediction of walking recovery and guide rehabilitation efforts after stroke. These include acute structural brain network disruption (utilizing MRI); blood biomarker levels (e.g., brain-derived neurotrophic factor and vascular endothelial growth factor); and clinical assessments of strength and mobility. The overall study objectives are to assess protocol feasibility and investigate relationships between select biomarkers and walking recovery to provide strong justification for a larger study on predictors of independent walking after stroke. The proposed objectives will be pursued through the following specific aims: 1) Assess feasibility of a larger study and develop methods for telehealth data collection; 2) Establish baseline levels of biomarkers and average change over time; and 3) Elucidate relationships between baseline levels of biomarkers and walking gains across time in persons after stroke. A longitudinal, observational study design will be utilized for this study. Thirty-five persons with acute (≤7 days) stroke will be recruited from the local medical center. Select inclusion criteria include presence of new lower limb weakness and assistance for walking; select exclusion criteria include cerebellar stroke or other neurological disorders such as Parkinson's Disease. Subjects will undergo clinical evaluation at week 1, 4, 9, 12, and 26 weeks post-stroke. MRI scans will occur within 12 days post-stroke and at 12 weeks post-stroke, and blood draws within 1 week, 1 to 2 weeks and at 12 weeks post-stroke. To assess feasibility the investigators will examine study processes, recruitment, resources, study management, and scientific assessment. To examine the role of acute clinical, neuroimaging, and physiological measures in predicting walking recovery, the investigators will examine relationships between these measures and walking outcome at 12-weeks post-stroke. The proposed research is expected to provide strong scientific support for future clinical trials designed to target therapies based on predicted functional potential. Such knowledge has the potential of enhancing mobility gains and patient independence following stroke.
The investigators will utilize a longitudinal, observational study design to investigate predictors of walking recovery post-stroke. Subjects will undergo clinical evaluation at week 1, 4, 9, 12, and 26 weeks after the initial onset of stroke symptoms; MRI scan within 12 days and at 12 weeks post-stroke; and blood draws at 1 week, 1 to 2 weeks and at 12 weeks post-stroke. Subjects will be recruited from the University of Vermont Medical Center (UVMMC), with a goal sample of 35 patients (accounts for 15% attrition). Subjects will provide written consent before participation.
Aim 1: Assess feasibility of a larger study and develop methods for telehealth data collection
Data Collection: To assess feasibility the investigators will examine study processes, recruitment, resources, study management, and scientific assessment.
Data Analyses: Feasibility questions will be examined using descriptive statistics and qualitative analyses. To ensure collection and dissemination of high quality data, the "CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial" will be used to guide data collection and analysis.
Aim 2: Establish baseline levels of biomarkers (clinical, neuroimaging, blood) and average change over time.
Experimental Protocol: Subjects will undergo baseline clinical assessment (within 1-week post-stroke), MRI scan (within 12 days post-stroke), and blood draw (within 1 week post-stroke). These same measures will be repeated 12 weeks after stroke (primary predictive outcome).
Data Analyses:
Aim 3: Elucidate relationships between baseline levels of biomarkers and walking gains across time in persons after stroke.
Experimental Protocol: Subjects will undergo the same experimental procedures as in Aims 1 and 2.
Data Analysis: To study the role of acute clinical, neuroimaging, and physiological measures in predicting recovery of independent walking post-stroke, the investigators will examine relationships between these measures and walking outcome as defined by the Functional Ambulation Category (FAC).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 35 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
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Adults (age ≥ 18 years old) with acute ischemic or intracerebral hemorrhagic stroke from the local medical center.
Inclusion criteria: 1) individuals with acute (≤ 7 days) ischemic or intra-cerebral hemorrhagic stroke; 2) ≥18 years of age; 3) presence of new lower limb weakness (less than 5/5 on manual muscle testing) on one side of the body or notation of weakness by MD or PT) on one side of the body; 4) unable to walk or requires supervision or assistance for walking.
Exclusion criteria: 1) cerebellar or bilateral stroke; 2) requirement for supervision or physical assistance to walk prior to admission; 3) other neurological disorders such as Parkinson's Disease or Multiple Sclerosis, 4) severe hearing impairment, 5) blindness, 6) actively receiving treatment for cancer, 7) not expected to survive for duration of the study, and 8) diagnosis of current clinical definition of active COVID-19.
Persons ≥ 18 years of age with acute (≤ 7 days) ischemic or intracerebral hemorrhagic stroke.
Diagnostic Test: MRI · Diagnostic Test: blood draw · Other: Clinical assessments
white matter integrity and brain structural connectivity metrics
post-stroke serum/plasma levels of BDNF, VEGF, IL-6, IL-10, CRP, TNFalpha, MMPs, IGF-1, cGP
measures of strength, balance, and mobility
Change in Functional Ambulation Category
Assessment of walking assistance
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in diffusion tensor imaging
fractional anisotropy and structural connectivity metrics
Time frame: within 12 days and at 12 weeks post-stroke
Change in blood markers - BDNF
serum BDNF
Time frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - VEGF
serum VEGF
Time frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in National Institutes of Health Stroke Scale
Stroke severity assessment; scores range from 0 (min) to 42 (max), with higher values indicating greater stroke severity (worse outcome)
Time frame: within 72 hours and 1 week post-stroke
Mini-Mental Status Exam
Cognition
Time frame: 1 week post-stroke
Change in 3-meter walk test
Assessment of gait speed
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Trunk Control Test
Assessment of trunk/postural control
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in lower extremity muscle strength as assessed by Medical Research Council grades
Assessment of specific muscle strength; scores range from 0 (no muscle contraction) to 5 (normal power)
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Berg Balance Scale
Assessment of static/dynamic sitting and standing balance; scores range from 0 (min) to 56 (max), with higher values indicating better balance/outcome
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Motricity Index (lower limb portion)
assessment of motor function/strength of the lower limbs
Time frame: week 1 , week 4, week 9, week 12, and week 26 s/p stroke
Change in Modified 30 second sit to stand
Assessment of lower limb power
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Fatigue Severity Scale
Assessment of fatigue level; scores range from 9 (min) to 63 (max), with higher values indicating greater fatigue severity (worse outcome)
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Barthel Index
Assessment of activities of daily living
Time frame: week 12 and 26 s/p stroke
Change in Modified Rankin Scale
Assessment of level of disability; scores range from 0 (min) to 5 (max), with higher values indicating greater disability (worse outcome)
Time frame: week 12 and 26 s/p stroke
Change in physical activity levels as assessed by the Physical Activity Vital Sign questionnaire
Assessment of physical activity levels; self-report of average number of days and minutes engaged in physical activity per week
Time frame: week 12 and 26 post-stroke
Change in Opal sensor metric - gait
Assessment of spatiotemporal parameters of gait
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Opal sensor metric - posture
Assessment of postural sway
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in blood markers - IL-6
IL-6
Time frame: within week 1,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - IL-10
IL-10
Time frame: within week 1,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - C reactive protein
CRP
Time frame: within week 1 ,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - TNFalpha
TNFalpha
Time frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - matrix metalloproteinase
MMP
Time frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - insulin-like growth factor-1
IGF-1
Time frame: within 1 week, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - cGP
cGP
Time frame: within 1 week, at 1-2 weeks and at 12 weeks post-stroke
Plan to share: Undecided — Data to be shared: unidentified clinical assessment and imaging data; serum/plasma samples will be stored in repository for future use.
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University of Vermont