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Completed

NCT Number: NCT04884555

SH-SS and GSH-GSSG Homeostasis in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard neurorehabilitation

Other

Routine post-stroke rehabilitation

Thiol-Disulphide Homeostasis

Diagnostic Test

Monitoring the levels of thiol and disulphide in serum

Oxidized-reduced Glutathione Homeostasis

Diagnostic Test

Monitoring the levels of intracellular oxidized glutathione and reduced glutathione in whole blood samples

Primary outcomes

  1. NIHSS Scores

    Time frame: at baseline (pre-treatment)

    National Institutes Of Health Stroke Scale Scores

  2. NIHSS Scores

    Time frame: after 4 weeks of treatment (post-treatment)

    National Institutes Of Health Stroke Scale Scores

  3. mRS

    Time frame: at baseline (pre-treatment)

    modified Rankin Scales

  4. mRS

    Time frame: after 4 weeks of treatment (post-treatment)

    modified Rankin Scales

  5. BI

    Time frame: at baseline (pre-treatment)

    Barthel Index for Activities of Daily Living

  6. BI

    Time frame: after 4 weeks of treatment (post-treatment)

    Barthel Index for Activities of Daily Living

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
May 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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