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

NCT04884555 | Completed

• 1 other identifier: AIBU-FTR-TA-01
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; Thiol; Disulphide; Glutathione

Outcome Measures

Primary Outcomes (6)

• NIHSS Scores

  National Institutes Of Health Stroke Scale Scores

  at baseline (pre-treatment)

• NIHSS Scores

  National Institutes Of Health Stroke Scale Scores

  after 4 weeks of treatment (post-treatment)

• mRS

  modified Rankin Scales

  at baseline (pre-treatment)

• mRS

  modified Rankin Scales

  after 4 weeks of treatment (post-treatment)

• BI

  Barthel Index for Activities of Daily Living

  at baseline (pre-treatment)

• BI

  Barthel Index for Activities of Daily Living

  after 4 weeks of treatment (post-treatment)

Study Arms (2)

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; Diagnostic Test: Thiol-Disulphide Homeostasis; Diagnostic Test: Oxidized-reduced Glutathione Homeostasis

Control

healthy volunteers who have not got any known disease and any sign in physical examination

Diagnostic Test: Thiol-Disulphide Homeostasis; Diagnostic Test: Oxidized-reduced Glutathione Homeostasis

Interventions

Standard neurorehabilitation OTHER

Routine post-stroke rehabilitation

post-stroke patient

Thiol-Disulphide Homeostasis DIAGNOSTIC_TEST

Monitoring the levels of thiol and disulphide in serum

Control; post-stroke patient

Oxidized-reduced Glutathione Homeostasis DIAGNOSTIC_TEST

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

Control; post-stroke patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 2749846 BACKGROUND

• 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.

  PMID: 10853723 BACKGROUND

• 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.

  PMID: 28626052 BACKGROUND

• 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.

  PMID: 25304913 BACKGROUND

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and whole blood samples

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tugba Alisik, MD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 13, 2021
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 31, 2021
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

TU (1)