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

NCT ID: NCT06010940

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-11

Study Completion Date

2023-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke, Acute Dysphagia Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

nasogastric tube and oral care

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.

Group Type EXPERIMENTAL

Dietary supplement

Intervention Type DIETARY_SUPPLEMENT

nasogastric tube and oral care

Physical therapy

Intervention Type OTHER

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

Interventions

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Dietary supplement

nasogastric tube and oral care

Intervention Type DIETARY_SUPPLEMENT

Physical therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

49 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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heba ahmed khalifa

Ass. Prof. Dr of Physical therapy for Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Physical Therapy

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 34746431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31958220 (View on PubMed)

Other Identifiers

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P.T.REC/012/002939

Identifier Type: -

Identifier Source: org_study_id

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