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

Completed

• Conditions: Stroke
• Interventions: Other: Standard neurorehabilitation; Diagnostic Test: Thiol-Disulphide Homeostasis; Diagnostic Test: Oxidized-reduced Glutathione Homeostasis

• Registration Number: NCT04884555
• Lead Sponsor: Abant Izzet Baysal University

Brief Summary

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

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 Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-31
• Study First Submitted: 2021-04-21
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
post-stroke patient	Thiol-Disulphide Homeostasis	patients with subacute stroke who have a stroke for the first time and admitted to the hospital for the first rehabilitation treatments
post-stroke patient	Standard neurorehabilitation	patients with subacute stroke who have a stroke for the first time and admitted to the hospital for the first rehabilitation treatments
Control	Oxidized-reduced Glutathione Homeostasis	healthy volunteers who have not got any known disease and any sign in physical examination
Control	Thiol-Disulphide Homeostasis	healthy volunteers who have not got any known disease and any sign in physical examination
post-stroke patient	Oxidized-reduced Glutathione Homeostasis	patients with subacute stroke who have a stroke for the first time and admitted to the hospital for the first rehabilitation treatments

Primary Outcome Measures

Name	Time	Method
NIHSS Scores	after 4 weeks of treatment (post-treatment)	National Institutes Of Health Stroke Scale Scores
mRS	after 4 weeks of treatment (post-treatment)	modified Rankin Scales
BI	after 4 weeks of treatment (post-treatment)	Barthel Index for Activities of Daily Living

Trial Locations

Locations (1)

Bolu Abant Izzet Baysal University; 🇹🇷 Bolu, Turkey