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

NCT ID: NCT04884555

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Standard neurorehabilitation

Intervention Type OTHER

Routine post-stroke rehabilitation

Thiol-Disulphide Homeostasis

Intervention Type DIAGNOSTIC_TEST

Monitoring the levels of thiol and disulphide in serum

Oxidized-reduced Glutathione Homeostasis

Intervention Type DIAGNOSTIC_TEST

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

Thiol-Disulphide Homeostasis

Intervention Type DIAGNOSTIC_TEST

Monitoring the levels of thiol and disulphide in serum

Oxidized-reduced Glutathione Homeostasis

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard neurorehabilitation

Routine post-stroke rehabilitation

Intervention Type OTHER

Thiol-Disulphide Homeostasis

Monitoring the levels of thiol and disulphide in serum

Intervention Type DIAGNOSTIC_TEST

Oxidized-reduced Glutathione Homeostasis

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tugba Alisik, MD

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bolu Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.

Reference Type BACKGROUND
PMID: 2749846 (View on PubMed)

Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.

Reference Type BACKGROUND
PMID: 10853723 (View on PubMed)

Broderick JP, Adeoye O, Elm J. Evolution of the Modified Rankin Scale and Its Use in Future Stroke Trials. Stroke. 2017 Jul;48(7):2007-2012. doi: 10.1161/STROKEAHA.117.017866. Epub 2017 Jun 16. No abstract available.

Reference Type BACKGROUND
PMID: 28626052 (View on PubMed)

Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem. 2014 Dec;47(18):326-32. doi: 10.1016/j.clinbiochem.2014.09.026. Epub 2014 Oct 7.

Reference Type BACKGROUND
PMID: 25304913 (View on PubMed)

Alisik, M., Neselioglu, S., & Erel, O. (2019). A colorimetric method to measure oxidized, reduced and total glutathione levels in erythrocytes, Journal of Laboratory Medicine, 43(5), 269-277

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AIBU-FTR-TA-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postural Kinesio Taping in Stroke Rehabilitation
NCT07334665 NOT_YET_RECRUITING NA