Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients

NCT05603377 | Unknown

• 1 other identifier: Soh-Med-22-10-18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke, main cause of disability in adults, is thought to be the primary cause of swallowing difficulty (dysphagia). Dysphagia is one of the common physical condition among patients with stroke, affecting the large number of stroke patients in the world. It is reported that the occurrence rate of post-stroke dysphagia (PSD) is varies widely, ranging from 19% to 81%, the reason may be associated with the type of stroke, the assessment tools, the timing of the assessment, and so on .Dysphagia is associated with pneumonia, malnutrition, dehydration, increased mortality, and poor long-term outcome. It has been shown that early detection of dysphagia allows for immediate intervention and thereby reduces morbidity, duration of hospitalization, and overall health care costs. Oropharyngeal dysphagia (OD) can have a high impact on the general health of affected patients and can produce two main types of complications in patients with post stroke: (1) those caused by impaired efficacy of swallow, present in 25%-75% of patients, which leads to malnutrition and dehydration and (2) impaired safety of swallow which leads to tracheobronchial aspiration that may cause pneumonia in 50% of cases. Both OD and aspiration are highly prevalent conditions in patients with stroke . Dysphagia is more common in hemorrhagic stroke compared with ischemic stroke, so far, most studies have focused on the latter, presumably due to its higher incidence .The recognition of a brain lesion pattern associated with oropharyngeal dysphagia could help to distinguish those patients in need of more in-depth evaluation and the subsequent adoption of preventive measures. However, it is difficult to predict which patients are susceptible to developing swallowing alterations depending on neuroimaging findings. However, the findings have been inconsistent, mainly due to simplification in the classification of brain injuries into a small number of groups, or to the different methods employed in assessing swallowing function

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (3)

• oral phase of swallow

  if there is residue in oral phase of swallow with fluids ,semisolids ,solids

  within 7 days

• pharyngeal phase of swallow

  if there is residue or penetration or aspiration post swallow with fluids ,semisolids, solids

  within 7 days

• brain imaging computed tomography CT or magnetic resonance imaging MRI

  brain imaging computed tomography CT or magnetic resonance imaging MRI correlation with oral phase and pharyngeal phase of swallow

  within 7 days

Study Arms (1)

study group

OTHER

Diagnostic Test: functional endoscopic evaluation of swallow

Interventions

functional endoscopic evaluation of swallow DIAGNOSTIC_TEST

functional endoscopic evaluation of swallow

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients\> (18 years). Conscious patients Stroke patients confirmed by brain imaging Stroke in the acute and sub-acute phase

You may not qualify if:

• Previous stroke Non stroke dysphagia History of other neurologic disorders other than cerebrovascular disease.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

• Abd-Allah F, Khedr E, Oraby MI, Bedair AS, Georgy SS, Moustafa RR. Stroke burden in Egypt: data from five epidemiological studies. Int J Neurosci. 2018 Aug;128(8):765-771. doi: 10.1080/00207454.2017.1420068. Epub 2018 Jan 4.

  PMID: 29258372 BACKGROUND

• Hess F, Foerch C, Keil F, Seiler A, Lapa S. Association of Lesion Pattern and Dysphagia in Acute Intracerebral Hemorrhage. Stroke. 2021 Aug;52(9):2921-2929. doi: 10.1161/STROKEAHA.120.032615. Epub 2021 May 18.

  PMID: 34000833 BACKGROUND

• Meng PP, Zhang SC, Han C, Wang Q, Bai GT, Yue SW. The Occurrence Rate of Swallowing Disorders After Stroke Patients in Asia: A PRISMA-Compliant Systematic Review and Meta-Analysis. J Stroke Cerebrovasc Dis. 2020 Oct;29(10):105113. doi: 10.1016/j.jstrokecerebrovasdis.2020.105113. Epub 2020 Jul 9.

  PMID: 32912517 BACKGROUND

• Wilmskoetter J, Bonilha L, Martin-Harris B, Elm JJ, Horn J, Bonilha HS. Mapping acute lesion locations to physiological swallow impairments after stroke. Neuroimage Clin. 2019;22:101685. doi: 10.1016/j.nicl.2019.101685. Epub 2019 Jan 22.

  PMID: 30711683 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

azhar E Ali, assisstant lecturer

CONTACT

01067042591; azhar.tamam@med.sohag.edu.eg

ahmed M Emam, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of phoniatrics, ENT department Sohag university

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: November 2, 2022
• Study Start: October 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

EG (1)