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

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06010940
Collaborator
(none)
30
1
2
35.6
0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Dietary supplement
  • Other: Physical therapy
N/A

Detailed Description

Thirty 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Physical Therapy of Dysphagia on Preventing Pneumonia in Acute Stroke Patients
Actual Study Start Date :
Oct 11, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

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

Dietary Supplement: Dietary supplement
nasogastric tube and oral care

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. The Gugging swallowing screen test score [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 [post intervention (after one month)]

    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. Clinical Score (A2DS2) [at baseline]

    It is a scale to detect risk of pneumonia. Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia

  4. Clinical Score (A2DS2) [post intervention (after one month)]

    It is a scale to detect risk of pneumonia.Consists of five items of scale which are: age, atrial fibrillation, dysphagia, sex and stroke severity. Total score of A2DS2 is 10. A2DS2 scoring tool: age more than 75 years=1, atrial fibrillation=1, dysphagia=2, male sex=1; stroke severity: is detected by NIHSS score. If NIHSS score is from 0-4=0, 5-15=3, and more than16=5. Patients with score of 6 or more are at high risk of pneumonia

  5. Number of participant with stroke associated pneumonia [at baseline]

    Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc

  6. Number of participant with stroke associated pneumonia [At middle of intervention (after two weeks)]

    Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention crI,teria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc

  7. Number of participant with stroke associated pneumonia [post intervention (after one month)]

    Measuring number of participants with stroke associated pneumonia in each group according to the modified Center for Disease Control and Prevention criteria that include; Fever (>38°C) , Leukopenia (<4000 WBC/mm3), worsening cough...etc

Eligibility Criteria

Criteria

Ages Eligible for Study:
49 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Physical Therapy Giza Egypt 11432

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
heba ahmed khalifa, Ass. Prof. Dr of Physical therapy for Neurology, Cairo University
ClinicalTrials.gov Identifier:
NCT06010940
Other Study ID Numbers:
  • P.T.REC/012/002939
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2023