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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06010940
Other study ID # P.T.REC/012/002939
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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)
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