Clinical trial NCT06010940: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Dysphagia
Pneumonia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 70
Sex: ALL
Minimum age (years): 49
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: The Gugging swallowing screen test score
timeFrame: at baseline
measure: The Gugging swallowing screen test score
timeFrame: At middle of intervention (after two weeks)
measure: The Gugging swallowing screen test score
timeFrame: post intervention (after one month)
Secondary outcomes:
measure: Incidence of participant with stroke associated pneumonia
timeFrame: at baseline
measure: Incidence of participant with stroke associated pneumonia
timeFrame: At middle of intervention (after two weeks)
measure: Incidence of participant with stroke associated pneumonia
timeFrame: post intervention (after one month)
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
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.
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.