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 : December 7, 2021
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Condition or disease | Intervention/treatment |
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Stroke, Acute Gait, Hemiplegic | Diagnostic Test: MRI Diagnostic Test: blood draw Other: Clinical assessments |

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 |
Actual Study Start Date : | December 2, 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 (≤ 7 days) ischemic or intracerebral hemorrhagic stroke.
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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 |
- Change in Functional Ambulation Category [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]Assessment of walking assistance
- Change in diffusion tensor imaging [ Time Frame: within 12 days and at 12 weeks post-stroke ]fractional anisotropy and structural connectivity metrics
- Change in blood markers - BDNF [ Time Frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke ]serum BDNF
- Change in blood markers - VEGF [ Time Frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke ]serum VEGF
- 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)
- Mini-Mental Status Exam [ Time Frame: 1 week post-stroke ]Cognition
- Change in 3-meter walk test [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]Assessment of gait speed
- Change in Trunk Control Test [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]Assessment of trunk/postural control
- Change in lower extremity muscle strength as assessed by Medical Research Council grades [ Time Frame: week 1, 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)
- Change in Berg Balance Scale [ Time Frame: week 1, 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
- Change in Motricity Index (lower limb portion) [ Time Frame: week 1 , week 4, week 9, week 12, and week 26 s/p stroke ]assessment of motor function/strength of the lower limbs
- Change in Modified 30 second sit to stand [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]Assessment of lower limb power
- Change in Fatigue Severity Scale [ Time Frame: week 1, 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)
- Change in Barthel Index [ Time Frame: week 12 and 26 s/p stroke ]Assessment of activities of daily living
- 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)
- 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
- Change in Opal sensor metric - gait [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]Assessment of spatiotemporal parameters of gait
- Change in Opal sensor metric - posture [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]Assessment of postural sway
- Change in blood markers - IL-6 [ Time Frame: within week 1,at 1-2 weeks and at 12 weeks post-stroke ]IL-6
- Change in blood markers - IL-10 [ Time Frame: within week 1,at 1-2 weeks and at 12 weeks post-stroke ]IL-10
- Change in blood markers - C reactive protein [ Time Frame: within week 1 ,at 1-2 weeks and at 12 weeks post-stroke ]CRP
- Change in blood markers - TNFalpha [ Time Frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke ]TNFalpha
- Change in blood markers - matrix metalloproteinase [ Time Frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke ]MMP
- Change in blood markers - insulin-like growth factor-1 [ Time Frame: within 1 week, at 1-2 weeks and at 12 weeks post-stroke ]IGF-1
- Change in blood markers - cGP [ Time Frame: within 1 week, at 1-2 weeks and at 12 weeks post-stroke ]cGP
Biospecimen Retention: Samples Without DNA

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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 |
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; 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.

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
Contact: Denise Peters, DPT, PhD | 802-656-1709 | denise.peters@med.uvm.edu |
United States, Vermont | |
University of Vermont Medical Center | Recruiting |
Burlington, Vermont, United States, 05405 | |
Contact: Research Coordinator nigel.miller@uvmhealth.org |
Principal Investigator: | Denise Peters, DPT, PhD | University of Vermont |
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: | December 7, 2021 |
Last Verified: | December 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Gait Disorders, Neurologic Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Neurologic Manifestations |