跳至主要内容
临床试验/CTRI/2024/06/068898
CTRI/2024/06/068898尚未招募2 期

To evaluate the combined effect of Mendelsohn maneuver and Shaker exercise on dysphagia severity, functional oral intake and swallowing ability in patients of acute stroke with dysphagia.

College of Physiotherapy PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月27日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Dysphagia Severity Rating Scale, Functional Oral Intake Scale, Eating Assessment Tool

研究概览

简要总结

**Title: "To evaluate the combined effect of Mendelsohn maneuver and Shaker exercise on dysphagia severity, functional oral intake and swallowing ability in patients of acute stroke with dysphagia".****Methods/Design:**This study is a double-blind, parallel group, active control, prospective and randomized controlled trial (RCT) investigating the effects of a 2-week supervised Mendelsohn maneuver and Shaker exercise on 20 patients of acute stroke and dysphagia. Main inclusion criteria are diagnosed acute (up to 2 weeks post stroke), stable stroke having difficulty in swallowing; alert and cooperative patients without any cognitive deficit (having MMSE > 22). The primary outcome measures are: Dysphagia Severity Rating Scale (DSRS), Functional Oral Intake Scale (FOIS) and Eating Assessment Tool (EAT-10). Secondary outcome measure include the Dysphagia Handicap Index (DHI). Participants randomized to the interventional group will participate in 2 supervised exercise sessions daily for 2 weeks. Participants randomized to the control group will receive oral strengthening exercise using straw and are taught about the compensatory measures to be adopted while eating swallowing.

Discussion: This RCT explores the combined effect of Mendelsohn maneuver and Shaker exercise in patients of acute stroke with dysphagia. Results will contribute to a better understanding of combined effect of Mendelsohn maneuver and Shaker exercise and inform intervention programs that will optimally improve physiological and psychosocial health in patients of acute stroke with dysphagia, and that are ultimately aimed at improving prognosis. The study results will contribute to the design of better rehabilitation programs for patients of acute stroke with dysphagia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed patients of acute (up to two weeks post-stroke), stable stroke having difficulty in swallowing
  • Alert and cooperative patients without any cognitive deficit (having MMSE greater than twenty two).

排除标准

  • Patients who have undergone pharyngeal surgical procedures of the strap muscles (mylohyoid, geniohyoid, anterior gastric, thyrohyoid muscle)
  • Patients who are unable to perform the exercise
  • Patients with tracheostomy tube
  • Patients with history of severe cervical spine disease
  • Patients with unstable medical condition.

结局指标

主要结局

Dysphagia Severity Rating Scale, Functional Oral Intake Scale, Eating Assessment Tool

时间窗: At baseline (day 0), post intervention (week 2). Follow up will be done at week 4 and 3rd month.

次要结局

  • Dysphagia Handicap Index(At baseline (day 0), post intervention (week 2). Follow up will be done at week 4 and 3rd month.)

研究者

发起方
College of Physiotherapy PGIMS Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Jalat James

College of Physiotherapy, PGIMS, Rohtak

研究点 (1)

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