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Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients

Primary Purpose

Stroke, Acute, Dysphagia, Pneumonia

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dietary supplement
Physical therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

49 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients were diagnosed of stroke dysphagia by a neurologist. Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16). Patients' age ranged from 49 to 65 years old. Patients had the ability to understand and follow instructions. Patients were able to sit in upright position. Exclusion Criteria: History of previous stroke. History of any swallowing problem. History of any disease, head and neck surgery or tumor that causes swallowing dysfunction. Any lung disease or pneumonia on admission. Patients with cognitive deficits or disturbed conscious level. Patients on mechanical ventilator. Patients with sensory or global aphasia.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

study group

Arm Description

Control group (A) was treated by nasogastric tube and oral care.

Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.

Outcomes

Primary Outcome Measures

The Gugging swallowing screen test score
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
The Gugging swallowing screen test score
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
Clinical Score (A2DS2)
It is a scale to detect risk of pneumonia. Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia
Clinical Score (A2DS2)
It is a scale to detect risk of pneumonia.Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia
Number of participant with stroke associated pneumonia
Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
Number of participant with stroke associated pneumonia
Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention crI,teria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
Number of participant with stroke associated pneumonia
Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc

Secondary Outcome Measures

Full Information

First Posted
August 17, 2023
Last Updated
August 24, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06010940
Brief Title
Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients
Official Title
Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 11, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
To investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients
Detailed Description
Thirty acute ischemic cerebrovascular stroke patients suffering from dysphagia were selected from the stroke unit in El-Kasr EL Ainy Hospital. Their ages ranged from 49 -65 years. Stroke dysphagia was diagnosed by a neurologist. Gugging swallowing screen and A2DS2 score was used to assess risk of developing pneumonia. Stroke associated pneumonia was diagnosed by: Recommended Diagnostic Criteria for Definite and Probable SAP in Patients Not Receiving Mechanical Ventilation Based on the CDC Criteria. The selected patients were randomly assigned into two equal groups control group (A) and study group (B). Control group (A) was treated by nasogastric tube and oral care. Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. Assessment was done before treatment, at the middle and at the end of treatment for each patient. Treatment was conducted for five sessions per week for one month.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Control group (A) was treated by nasogastric tube and oral care.
Arm Title
study group
Arm Type
Experimental
Arm Description
Study group (B) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary supplement
Intervention Description
nasogastric tube and oral care
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.
Primary Outcome Measure Information:
Title
The Gugging swallowing screen test score
Description
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
Time Frame
at baseline
Title
The Gugging swallowing screen test score
Description
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
Time Frame
post intervention (after one month)
Title
Clinical Score (A2DS2)
Description
It is a scale to detect risk of pneumonia. Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia
Time Frame
at baseline
Title
Clinical Score (A2DS2)
Description
It is a scale to detect risk of pneumonia.Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia
Time Frame
post intervention (after one month)
Title
Number of participant with stroke associated pneumonia
Description
Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
Time Frame
at baseline
Title
Number of participant with stroke associated pneumonia
Description
Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention crI,teria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
Time Frame
At middle of intervention (after two weeks)
Title
Number of participant with stroke associated pneumonia
Description
Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc
Time Frame
post intervention (after one month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
49 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients were diagnosed of stroke dysphagia by a neurologist. Severity of stroke ranged from mild to moderate according to NIHSS score (NIHSS less than or equal 16). Patients' age ranged from 49 to 65 years old. Patients had the ability to understand and follow instructions. Patients were able to sit in upright position. Exclusion Criteria: History of previous stroke. History of any swallowing problem. History of any disease, head and neck surgery or tumor that causes swallowing dysfunction. Any lung disease or pneumonia on admission. Patients with cognitive deficits or disturbed conscious level. Patients on mechanical ventilator. Patients with sensory or global aphasia.
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34746431
Citation
Dziewas R, Michou E, Trapl-Grundschober M, Lal A, Arsava EM, Bath PM, Clave P, Glahn J, Hamdy S, Pownall S, Schindler A, Walshe M, Wirth R, Wright D, Verin E. European Stroke Organisation and European Society for Swallowing Disorders guideline for the diagnosis and treatment of post-stroke dysphagia. Eur Stroke J. 2021 Sep;6(3):LXXXIX-CXV. doi: 10.1177/23969873211039721. Epub 2021 Oct 13.
Results Reference
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PubMed Identifier
31958220
Citation
Lo YK, Fu TC, Chen CP, Yuan SS, Hsu CC. Involvement of swallowing therapy is associated with improved long-term survival in patients with post-stroke dysphagia. Eur J Phys Rehabil Med. 2019 Dec;55(6):728-734. doi: 10.23736/S1973-9087.19.05893-3.
Results Reference
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Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients

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