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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06010940
• Other study ID #: P.T.REC/012/002939
• Status: Completed
• Phase: N/A
• Start date: October 11, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 30, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 49 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Pneumonia
• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline
Primary	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	At middle of intervention (after two weeks)
Primary	The Gugging swallowing screen test score	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	Incidence of participant with stroke associated pneumonia	Measuring number and percentage of participants with stroke associated pneumonia in each group	at baseline
Secondary	Incidence of participant with stroke associated pneumonia	Measuring number and percentage of participants with stroke associated pneumonia in each group	At middle of intervention (after two weeks)
Secondary	Incidence of participant with stroke associated pneumonia	Measuring number and percentage of participants with stroke associated pneumonia in each group	post intervention (after one month)