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Biomarkers of Independent Walking Post-Stroke

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ClinicalTrials.gov Identifier: NCT05004389
Recruitment Status : Recruiting
First Posted : August 13, 2021
Last Update Posted : August 13, 2021
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Denise Peters, University of Vermont

Brief Summary:
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 (≤3 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 within 3 days, 1, 4, 9, 12, and 26 weeks post-stroke. MRI scans will occur within 1 week and 12 weeks post-stroke, and blood draws at 72 hours, 1 week, and 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.

Condition or disease Intervention/treatment
Stroke, Acute Gait, Hemiplegic Diagnostic Test: MRI Diagnostic Test: blood draw Other: Clinical assessments

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Clinical, Blood, and Neuroimaging Biomarkers as Predictors of Independent Walking Post-Stroke
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Group/Cohort Intervention/treatment
Acute Stroke
Persons ≥18 years of age with acute (≤3 days) ischemic or intracerebral hemorrhagic stroke.
Diagnostic Test: MRI
white matter integrity and brain structural connectivity metrics

Diagnostic Test: blood draw
post-stroke serum/plasma levels of BDNF, VEGF, IL-6, IL-10, CRP, TNFalpha, MMPs, IGF-1, cGP

Other: Clinical assessments
measures of strength, balance, and mobility




Primary Outcome Measures :
  1. Change in Functional Ambulation Category [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of walking assistance

  2. Change in diffusion tensor imaging [ Time Frame: week 1 and 12 post-stroke ]
    fractional anisotropy and structural connectivity metrics

  3. Change in blood markers - BDNF [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    serum BDNF

  4. Change in blood markers - VEGF [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    serum VEGF


Secondary Outcome Measures :
  1. Change in National Institutes of Health Stroke Scale [ Time Frame: within 72 hours and 1 week post-stroke ]
    Stroke severity assessment; scores range from 0 (min) to 42 (max), with higher values indicating greater stroke severity (worse outcome)

  2. Mini-Mental Status Exam [ Time Frame: 1 week post-stroke ]
    Cognition

  3. Change in 3-meter walk test [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of gait speed

  4. Change in Trunk Control Test [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of trunk/postural control

  5. Change in lower extremity muscle strength as assessed by Medical Research Council grades [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of specific muscle strength; scores range from 0 (no muscle contraction) to 5 (normal power)

  6. Change in Berg Balance Scale [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of static/dynamic sitting and standing balance; scores range from 0 (min) to 56 (max), with higher values indicating better balance/outcome

  7. Change in Motricity Index (lower limb portion) [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    assessment of motor function/strength of the lower limbs

  8. Change in Modified 30 second sit to stand [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of lower limb power

  9. Change in Fatigue Severity Scale [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of fatigue level; scores range from 9 (min) to 63 (max), with higher values indicating greater fatigue severity (worse outcome)

  10. Change in Barthel Index [ Time Frame: week 12 and 26 s/p stroke ]
    Assessment of activities of daily living

  11. Change in Modified Rankin Scale [ Time Frame: week 12 and 26 s/p stroke ]
    Assessment of level of disability; scores range from 0 (min) to 5 (max), with higher values indicating greater disability (worse outcome)

  12. Change in physical activity levels as assessed by the Physical Activity Vital Sign questionnaire [ Time Frame: week 12 and 26 post-stroke ]
    Assessment of physical activity levels; self-report of average number of days and minutes engaged in physical activity per week

  13. Change in Opal sensor metric - gait [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of spatiotemporal parameters of gait

  14. Change in Opal sensor metric - posture [ Time Frame: baseline, week 4, week 9, week 12, and week 26 s/p stroke ]
    Assessment of postural sway

  15. Change in blood markers - IL-6 [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    IL-6

  16. Change in blood markers - IL-10 [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    IL-10

  17. Change in blood markers - C reactive protein [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    CRP

  18. Change in blood markers - TNFalpha [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    TNFalpha

  19. Change in blood markers - matrix metalloproteinase [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    MMP

  20. Change in blood markers - insulin-like growth factor-1 [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    IGF-1

  21. Change in blood markers - cGP [ Time Frame: within 72 hours, 1 and 12 weeks post-stroke ]
    cGP


Biospecimen Retention:   Samples Without DNA
serum, plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
local medical center
Criteria

Inclusion Criteria:

1) individuals with acute (≤ 3 days) ischemic or intracerebral hemorrhagic stroke; 2) ≥18 years of age; 3) presence of new lower limb weakness on one side of the body; 4) ability to follow simple 2-step commands; 5) requires supervision or assistance for walking

Exclusion Criteria:

1) cerebellar or bilateral stroke; 2) communication or cognitive deficits precluding informed consent; 3) requirement for supervision or physical assistance to walk prior to admission; 4) contraindication to MRI; 5) other neurological disorders such as Parkinson's Disease or Multiple Sclerosis, 6) severe hearing impairment, 7) blindness, 8) actively receiving treatment for cancer, 9) not expected to survive for duration of the study, and 10) diagnosis of current clinical definition of active Corona Virus-19.


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): NCT05004389


Contacts
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Contact: Denise Peters, DPT, PhD 802-656-1709 denise.peters@med.uvm.edu

Locations
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United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05405
Contact: Research Coordinator       nigel.miller@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Denise Peters, DPT, PhD University of Vermont
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Responsible Party: Denise Peters, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT05004389    
Other Study ID Numbers: 00000696
P20GM135007 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2021    Key Record Dates
Last Update Posted: August 13, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Gait Disorders, Neurologic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations