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临床试验/NCT06370390
NCT06370390Unknown不适用

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

Copka Sonpashan0 个研究点目标入组 200 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Standardized Swallowing Assessment Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Standardized Swallowing Assessment Scale

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Copka Sonpashan
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Copka Sonpashan

Research Director

Chao Phya Abhaibhubejhr Hospital

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