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Completed

NCT Number: NCT06010940

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Supplement

Dietary Supplement

nasogastric tube and oral care

Physical Therapy

Other

Designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Incidence of participant with stroke associated pneumonia

    Time frame: at baseline

    Measuring number and percentage of participants with stroke associated pneumonia in each group

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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