SH-SS and GSH-GSSG Homeostasis in Post-stroke Patients

May 7, 2021 updated by: Abant Izzet Baysal University

Association of Extracellular Thiol-disulfide and Intracellular Oxidized-reduced Glutathione Homeostasis With Severity and Clinical Prognosis of Post-stroke Patients

In patients undergoing physical therapy after stroke, extracellular thiol-disulfide balance and intracellular oxidized-reduced glutathione balance levels will be monitored. The main objectives of this study are; (1) to determine the differences between thiol-disulfide and GSH-GSSG balances in stroke patients compared to healthy volunteers, (2) to evaluate the relationship of these balances with the severity of stroke, (3) to determine the predictive value of the levels of these balances on clinical prognosis and functional recovery outcomes, and (4) to investigate and to examine the effects of the physical therapy process on these parameters and functional recovery and their relationship with each other.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is among the most common causes of all deaths and Disability-Adjusted Life Years (DALYs) in the world. There is a close relationship between stroke pathophysiology and post-stroke clinic with oxidative stress. Thiol-disulfide homeostasis systems, which is one of the important extracellular and intracellular oxidative stress markers, showing antioxidant capacity with SH form, and oxidative status with disulfide (SS) form. In this study, we aimed to evaluate the relationship between the clinical outcome of subacute stroke patients and extracellular thiol-disulfide (SH-SS) and intracellular oxidized-reduced glutathione (GSSG-GSH) homeostasis and the comparison of these with healthy volunteers. In addition, the effect of the rehabilitation program on these oxidative stress markers and clinical scores and the predictive value of these oxidative stress parameters on prognosis were also evaluated. The main objectives of this study are; (1) to determine the differences between thiol-disulfide and GSH-GSSG balances in stroke patients compared to healthy volunteers, (2) to evaluate the relationship of these balances with the severity of stroke, (3) to determine the predictive value of the levels of these balances on clinical prognosis and functional recovery outcomes, and (4) to investigate and to examine the effects of the physical therapy process on these parameters and functional recovery and their relationship with each other.

In this study, which is designed as a prospective observational study, patients with subacute stroke who have a stroke for the first time and are admitted to the hospital for the first rehabilitation treatment and healthy volunteers (control group) will be included. The clinical conditions of the patients will be evaluated at the beginning and after the 4-week rehabilitation program at the time of discharge by National Institutes of Health Stroke Scale Scores (NIHSS), modified Rankin Scale (mRS) and Barthel Daily Living Activities Index (BI). Serum and whole blood samples will be obtained from the patient group at the beginning and at discharge, and from the control group. The SH-SS homeostasis parameters (SH, Total SH, SS and SS / SH percent ratio) from serum samples and GSSG-GSH homeostasis parameters (GSH, Total GSH, GSSG and GSSG / GSH percentage ratio) from whole blood samples will be determined. Age, gender, hemiplegic side, type of stroke will be noted. Later, statistical analysis will be conducted.

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bolu, Turkey
        • Bolu abant Izzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post-stroke patients group admitted to hospital to take rehablititation and physiotherapy within 1 to 6 months of stroke onset.

Healthy adult volunteers (control) group (> 18 years of age) with no known disease and no findings on physical examination

Description

Inclusion Criteria:

  • diagnosis of a first-ever stroke verified by computed tomography (CT) or magnetic resonance imaging (MRI) reports
  • admitted to the hospital for standard neurorehabilitation within 1 to 6 months of stroke onset
  • healthy individuals (for control group)

Exclusion Criteria:

  • significant acute medical illness (e.g., autoimmune disease, infection, tumor, heart failure, renal or liver dysfunction)
  • significant acute neurological illness other than stroke (e.g., head trauma, brain abscess, brain tumor, migraine attack, seizure)
  • cannot adapt to work
  • previous history of neurorehabilitation therapy
  • taking the antioxidant supplements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
post-stroke patient
patients with subacute stroke who have a stroke for the first time and admitted to the hospital for the first rehabilitation treatments
Other: Standard neurorehabilitation
Routine post-stroke rehabilitation
Diagnostic test: Thiol-Disulphide Homeostasis
Monitoring the levels of thiol and disulphide in serum
Diagnostic test: Oxidized-reduced Glutathione Homeostasis
Monitoring the levels of intracellular oxidized glutathione and reduced glutathione in whole blood samples
Control
healthy volunteers who have not got any known disease and any sign in physical examination
Diagnostic test: Thiol-Disulphide Homeostasis
Monitoring the levels of thiol and disulphide in serum
Diagnostic test: Oxidized-reduced Glutathione Homeostasis
Monitoring the levels of intracellular oxidized glutathione and reduced glutathione in whole blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS Scores
Time Frame: at baseline (pre-treatment)
National Institutes Of Health Stroke Scale Scores
at baseline (pre-treatment)
NIHSS Scores
Time Frame: after 4 weeks of treatment (post-treatment)
National Institutes Of Health Stroke Scale Scores
after 4 weeks of treatment (post-treatment)
mRS
Time Frame: at baseline (pre-treatment)
modified Rankin Scales
at baseline (pre-treatment)
mRS
Time Frame: after 4 weeks of treatment (post-treatment)
modified Rankin Scales
after 4 weeks of treatment (post-treatment)
BI
Time Frame: at baseline (pre-treatment)
Barthel Index for Activities of Daily Living
at baseline (pre-treatment)
BI
Time Frame: after 4 weeks of treatment (post-treatment)
Barthel Index for Activities of Daily Living
after 4 weeks of treatment (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Tugba Alisik, MD, Abant Izzet Baysal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIBU-FTR-TA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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