Recruiting

Observational Study

Sponsor:

University of Vermont

Code:

NCT05004389

Conditions

Stroke, Acute

Gait, Hemiplegic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI

blood draw

Clinical assessments

Study Details

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 (≤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.

Conditions

Stroke, Acute

Gait, Hemiplegic

Study ID

NCT05004389

Start date

Dec 2, 2021

Status verified date

Mar, 2023

Completion date

May, 2023

Anticipated

Primary completion date

May, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

Acute Stroke

Persons ≥ 18 years of age with acute (≤ 7 days) ischemic or intracerebral hemorrhagic stroke.

Interventions

MRI

white matter integrity and brain structural connectivity metrics

blood draw

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

Clinical assessments

measures of strength, balance, and mobility

Primary outcome measure

  • Change in Functional Ambulation Category [ Time Frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke ]
  • Change in diffusion tensor imaging [ Time Frame: within 12 days and at 12 weeks post-stroke ]
  • Change in blood markers - BDNF [ Time Frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke ]
  • Change in blood markers - VEGF [ Time Frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke ]

Central Contacts and Locations

Central contacts

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Swapna Research Coordinator

swapna.balakrishnan@uvm.edu

More Information

Sponsor

University of Vermont

Last update posted

Mar 14, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2023-03-14.