Skip to main content
Clinical Trials/NCT06370390
NCT06370390
Not yet recruiting
Not Applicable

Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia: a Randomized Controlled Trial

Copka Sonpashan0 sites200 target enrollmentApril 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Copka Sonpashan
Enrollment
200
Primary Endpoint
Standardized Swallowing Assessment Scale
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Detailed Description

Stroke is complicated by oropharyngeal dysphagia in 29 to 81% of patients. Up to 40% of these individuals continue to experience swallowing difficulty even after a year later, which is associated with an increased risk of consequences such as aspiration pneumonia, dehydration, and malnutrition. Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Registry
clinicaltrials.gov
Start Date
April 2024
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Copka Sonpashan
Responsible Party
Sponsor Investigator
Principal Investigator

Copka Sonpashan

Research Director

Chao Phya Abhaibhubejhr Hospital

Eligibility Criteria

Inclusion Criteria

  • Age over 65 years old.
  • No hospitalization within the past six months.
  • With clear consciousness and able to cooperate with questionnaires and training.
  • The elderly people who voluntarily participate and agree to adhere until the end of the study.
  • early dysphagia.

Exclusion Criteria

  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Physical disability.
  • Simultaneously receiving other therapies that might influence this study.
  • Individuals with a gastrostomy.
  • Abnormalities of the oral, pharyngeal, or esophageal structures.

Outcomes

Primary Outcomes

Standardized Swallowing Assessment Scale

Time Frame: day 1 and day 28

The Standardized Swallowing Assessment Scale is a commonly used tool for evaluating swallowing function. It is widely applied in medical and rehabilitation fields to assess an individual's swallowing ability and the smooth passage of food/liquid through the esophagus. The scale ranges from 18 to 46, with lower scores indicating better swallowing function.

Secondary Outcomes

  • Time consumed in eating(day 1 and day 28)
  • Penetration-Aspiration Scale(day 1 and day 28)
  • 15-item Geriatric Depression Scale(day 1 and day 28)

Similar Trials