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

NCT06010940 | Completed

• 1 other identifier: P.T.REC/012/002939
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke, Acute; Dysphagia; Pneumonia

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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 Outcomes (3)

• Incidence of participant with stroke associated pneumonia

  at baseline

• Incidence of participant with stroke associated pneumonia

  At middle of intervention (after two weeks)

• Incidence of participant with stroke associated pneumonia

  post intervention (after one month)

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Dietary Supplement: Dietary supplement

study group

EXPERIMENTAL

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; Other: Physical therapy

Interventions

Dietary supplement DIETARY_SUPPLEMENT

nasogastric tube and oral care

control group; study group

Physical therapy OTHER

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

study group

Eligibility Criteria

• Age: 49 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, 11432, Egypt

Location

Related 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.

  PMID: 34746431 BACKGROUND

• 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.

  PMID: 31958220 BACKGROUND

MeSH Terms

Conditions

Stroke; Deglutition Disorders; Pneumonia

Interventions

Dietary Supplements; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr of Physical therapy for Neurology

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 25, 2023
• Study Start: October 11, 2020
• Primary Completion: October 26, 2023
• Study Completion: November 30, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)