Stroke, AcuteNCT05004389
Biomarkers of Independent Walking Post-Stroke
An observational study of Stroke, Acute and Gait, Hemiplegic, run by University of Vermont at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Gait, Hemiplegic
- What is being tested?
- MRI, blood draw and Clinical assessments
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05405
Swapna Research Coordinator, swapna.balakrishnan@uvm.edu
About this study
Official title: Investigation of Clinical, Blood, and Neuroimaging Biomarkers as Predictors of Independent Walking Post-Stroke
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.
Read the detailed description
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:
- Establishing baseline levels of clinical measures, neuroimaging and blood biomarkers: To determine the variability in participants' walking ability/balance/strength, post-stroke preservation of sensorimotor connectivity, and acute changes in blood markers associated with immune response (IL-6, IL-10, cross-reacting protein, TNF alpha), neural function (BDNF), and blood vessel/ circulation (VEGF, matrix metalloproteinase, insulin like growth factor-1, cGP), descriptive statistics will be obtained. Results will be stratified by stroke characteristics and NIHSS score.
- Quantifying change over time for clinical measures: defined as the average difference between 1-4-,9-,12-, and 26-week values. To examine change over time, the investigators will perform paired t-tests (or non-parametric equivalent) and effect size calculations on all outcome measures, using the 12 week post-stroke timepoint as the primary outcome. The investigators will also use the following minimal clinically important difference (MCID) or minimal detectable change (MDC) values to determine if observed statistical differences are clinically relevant: 0.16 m/s change in gait speed, 6-point change in Berg Balance Scale, and a change of three repetitions in 30 second Sit-To-Stand.
- Quantifying change over time for neuroimaging and blood biomarkers: defined as the average difference between baseline and 12-week values. To examine change over time, the investigators will perform paired t-tests (or non-parametric equivalent) and effect size calculations.
- Secondary analyses: will be performed with assistance and training from Core C (e.g., 5 dimensions spatial-temporal maps of walking biomechanics and/or muscle activation).
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).
- Identifying the time to regaining independent walking after stroke: defined as the time post-stroke (as measured at 1, 4, 9, 12, or 26 weeks post-stroke) at which a participant achieves a score of ≥4 on the FAC.
- Quantifying the relationship between acute measures and walking outcome at 12 weeks post-stroke (primary predictive outcome): the relationship between clinical, MRI, and blood biomarkers and walking outcome at 12 weeks post-stroke (± independently walking) will be examined using logistic regression, correcting for potential confounders [age, sex, stroke severity (NIHSS)]. Secondary analyses will be performed by evaluating trends over time (repeated measures model).
- Conditions
- Stroke, Acute, Gait, Hemiplegic
- Being tested
- MRI, blood draw, Clinical assessments
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
white matter integrity and brain structural connectivity metrics
blood drawDiagnostic test
post-stroke serum/plasma levels of BDNF, VEGF, IL-6, IL-10, CRP, TNFalpha, MMPs, IGF-1, cGP
Clinical assessmentsOther
measures of strength, balance, and mobility
| Study group | Role | What they receive |
|---|---|---|
| Acute Stroke | Persons ≥ 18 years of age with acute (≤ 7 days) ischemic or intracerebral hemorrhagic stroke. Receives: Diagnostic Test: MRI; Diagnostic Test: blood draw; Other: Clinical assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Ambulation Category
Assessment of walking assistance
Measured: 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
Measured: within 12 days and at 12 weeks post-stroke
Change in blood markers - BDNF
serum BDNF
Measured: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - VEGF
serum VEGF
Measured: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Secondary outcomes (21)
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)
Measured: within 72 hours and 1 week post-stroke
Mini-Mental Status Exam
Cognition
Measured: 1 week post-stroke
Change in 3-meter walk test
Assessment of gait speed
Measured: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Trunk Control Test
Assessment of trunk/postural control
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Barthel Index
Assessment of activities of daily living
Measured: 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)
Measured: 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
Measured: week 12 and 26 post-stroke
Change in Opal sensor metric - gait
Assessment of spatiotemporal parameters of gait
Measured: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Opal sensor metric - posture
Assessment of postural sway
Measured: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in blood markers - IL-6
IL-6
Measured: within week 1,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - IL-10
IL-10
Measured: within week 1,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - C reactive protein
CRP
Measured: within week 1 ,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - TNFalpha
TNFalpha
Measured: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - matrix metalloproteinase
MMP
Measured: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - insulin-like growth factor-1
IGF-1
Measured: within 1 week, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - cGP
cGP
Measured: within 1 week, at 1-2 weeks and at 12 weeks post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start2 Dec 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Denise Peters, University of Vermont
- Investigators
- Denise Peters, DPT, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004389
- Sponsor's protocol ID
- 00000696
- Other IDs
- P20GM135007
- Status last verified
- Mar 2023
- First submitted
- 27 Jul 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data to be shared: unidentified clinical assessment and imaging data; serum/plasma samples will be stored in repository for future use.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Clinical, Blood, and Neuroimaging Biomarkers as Predictors of Independent Walking Post-Stroke
- ClinicalTrials.gov ID
- NCT05004389
- Acronym / sponsor ID
- 00000696
- Conditions
- Stroke, Acute, Gait, Hemiplegic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Establishing baseline levels of clinical measures, neuroimaging and blood biomarkers: To determine the variability in participants' walking ability/balance/strength, post-stroke preservation of sensorimotor connectivity, and acute changes in blood markers associated with immune response (IL-6, IL-10, cross-reacting protein, TNF alpha), neural function (BDNF), and blood vessel/ circulation (VEGF, matrix metalloproteinase, insulin like growth factor-1, cGP), descriptive statistics will be obtained. Results will be stratified by stroke characteristics and NIHSS score.
- Quantifying change over time for clinical measures: defined as the average difference between 1-4-,9-,12-, and 26-week values. To examine change over time, the investigators will perform paired t-tests (or non-parametric equivalent) and effect size calculations on all outcome measures, using the 12 week post-stroke timepoint as the primary outcome. The investigators will also use the following minimal clinically important difference (MCID) or minimal detectable change (MDC) values to determine if observed statistical differences are clinically relevant: 0.16 m/s change in gait speed, 6-point change in Berg Balance Scale, and a change of three repetitions in 30 second Sit-To-Stand.
- Quantifying change over time for neuroimaging and blood biomarkers: defined as the average difference between baseline and 12-week values. To examine change over time, the investigators will perform paired t-tests (or non-parametric equivalent) and effect size calculations.
- Secondary analyses: will be performed with assistance and training from Core C (e.g., 5 dimensions spatial-temporal maps of walking biomechanics and/or muscle activation).
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).
- Identifying the time to regaining independent walking after stroke: defined as the time post-stroke (as measured at 1, 4, 9, 12, or 26 weeks post-stroke) at which a participant achieves a score of ≥4 on the FAC.
- Quantifying the relationship between acute measures and walking outcome at 12 weeks post-stroke (primary predictive outcome): the relationship between clinical, MRI, and blood biomarkers and walking outcome at 12 weeks post-stroke (± independently walking) will be examined using logistic regression, correcting for potential confounders [age, sex, stroke severity (NIHSS)]. Secondary analyses will be performed by evaluating trends over time (repeated measures model).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Stroke | – | Diagnostic Test: MRI, Diagnostic Test: blood draw, Other: Clinical assessmentsPersons ≥ 18 years of age with acute (≤ 7 days) ischemic or intracerebral hemorrhagic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (age ≥ 18 years old) with acute ischemic or intracerebral hemorrhagic stroke from the local medical center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIwhite matter integrity and brain structural connectivity metrics | Diagnostic test | Acute Stroke |
| blood drawpost-stroke serum/plasma levels of BDNF, VEGF, IL-6, IL-10, CRP, TNFalpha, MMPs, IGF-1, cGP | Diagnostic test | Acute Stroke |
| Clinical assessmentsmeasures of strength, balance, and mobility | Other | Acute Stroke |
Primary outcome
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
21 secondary outcomes
Change in National Institutes of Health Stroke Scale
Time frame: within 72 hours and 1 week post-stroke
Mini-Mental Status Exam
Time frame: 1 week post-stroke
Change in 3-meter walk test
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Trunk Control Test
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
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Berg Balance Scale
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Motricity Index (lower limb portion)
Time frame: week 1 , week 4, week 9, week 12, and week 26 s/p stroke
Change in Modified 30 second sit to stand
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Fatigue Severity Scale
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Barthel Index
Time frame: week 12 and 26 s/p stroke
Change in Modified Rankin Scale
Time frame: week 12 and 26 s/p stroke
Change in physical activity levels as assessed by the Physical Activity Vital Sign questionnaire
Time frame: week 12 and 26 post-stroke
Change in Opal sensor metric - gait
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in Opal sensor metric - posture
Time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke
Change in blood markers - IL-6
Time frame: within week 1,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - IL-10
Time frame: within week 1,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - C reactive protein
Time frame: within week 1 ,at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - TNFalpha
Time frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - matrix metalloproteinase
Time frame: within week 1, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - insulin-like growth factor-1
Time frame: within 1 week, at 1-2 weeks and at 12 weeks post-stroke
Change in blood markers - cGP
Time frame: within 1 week, at 1-2 weeks and at 12 weeks post-stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Peters, DPT, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Gait, Hemiplegic, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Peters, DPT, PhD (802-656-1709, denise.peters@med.uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Ambulation Category (time frame: week 1, week 4, week 9, week 12, and week 26 s/p stroke). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.