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

May 5, 2024 updated by: heba ahmed khalifa, Cairo University
To investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Seventy 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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11432
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Control group (A) was treated by nasogastric tube and oral care.
Dietary supplement: Dietary supplement
nasogastric tube and oral care
Experimental: study group
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.
Dietary supplement: Dietary supplement
nasogastric tube and oral care
Other: Physical therapy
Designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gugging swallowing screen test score
Time Frame: at baseline
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
at baseline
The Gugging swallowing screen test score
Time Frame: At middle of intervention (after two weeks)
Test used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
At middle of intervention (after two weeks)
The Gugging swallowing screen test score
Time Frame: post intervention (after one month)
est used to detect dysphagia and aspiration risk. Score ranged from 0 to 20 where 0 indicates sever dysphagia and 20 indicates normal swallowing
post intervention (after one month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of participant with stroke associated pneumonia
Time Frame: at baseline
Measuring number and percentage of participants with stroke associated pneumonia in each group
at baseline
Incidence of participant with stroke associated pneumonia
Time Frame: At middle of intervention (after two weeks)
Measuring number and percentage of participants with stroke associated pneumonia in each group
At middle of intervention (after two weeks)
Incidence of participant with stroke associated pneumonia
Time Frame: post intervention (after one month)
Measuring number and percentage of participants with stroke associated pneumonia in each group
post intervention (after one month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2020

Primary Completion (Actual)

October 26, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 24, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 5, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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