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Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients

Primary Purpose

Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
functional endoscopic evaluation of swallow
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Adult patients> (18 years). Conscious patients Stroke patients confirmed by brain imaging Stroke in the acute and sub-acute phase Exclusion Criteria: Previous stroke Non stroke dysphagia History of other neurologic disorders other than cerebrovascular disease.

Sites / Locations

  • Sohag University hospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

study group

Arm Description

Outcomes

Primary Outcome Measures

oral phase of swallow
if there is residue in oral phase of swallow with fluids ,semisolids ,solids
pharyngeal phase of swallow
if there is residue or penetration or aspiration post swallow with fluids ,semisolids, solids
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

Secondary Outcome Measures

Full Information

First Posted
October 16, 2022
Last Updated
October 30, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05603377
Brief Title
Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients
Official Title
Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
functional endoscopic evaluation of swallow
Intervention Description
functional endoscopic evaluation of swallow
Primary Outcome Measure Information:
Title
oral phase of swallow
Description
if there is residue in oral phase of swallow with fluids ,semisolids ,solids
Time Frame
within 7 days
Title
pharyngeal phase of swallow
Description
if there is residue or penetration or aspiration post swallow with fluids ,semisolids, solids
Time Frame
within 7 days
Title
brain imaging computed tomography CT or magnetic resonance imaging MRI
Description
brain imaging computed tomography CT or magnetic resonance imaging MRI correlation with oral phase and pharyngeal phase of swallow
Time Frame
within 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Adult patients> (18 years). Conscious patients Stroke patients confirmed by brain imaging Stroke in the acute and sub-acute phase Exclusion Criteria: Previous stroke Non stroke dysphagia History of other neurologic disorders other than cerebrovascular disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
azhar E Ali, assisstant lecturer
Phone
01067042591
Email
azhar.tamam@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed M Emam, Professor
Facility Information:
Facility Name
Sohag University hospitals
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy M Amin, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29258372
Citation
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.
Results Reference
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PubMed Identifier
34000833
Citation
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.
Results Reference
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PubMed Identifier
32912517
Citation
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.
Results Reference
background
PubMed Identifier
30711683
Citation
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.
Results Reference
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Neuro Anatomical Correlation of Oropharyngeal Swallowing Revisited in Cerebrovascular Stroke Patients

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