Effect of Pharyngeal Exerciser in Rehabilitation of Pharyngeal Phase of Swallowing in Patients With Dysphagia

Medical College of Wisconsin1 个研究点分布在 1 个国家目标入组 160 人开始时间: 2015年6月9日最近更新: 2026年2月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: Medical College of Wisconsin
入组人数: 160
试验地点: 1
主要终点: maximum superior laryngeal excursion

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this a clinical trial is to test the effect of a pharyngeal exerciser in rehabilitation of pharyngeal phase of swallowing in patients with dysphagia. The main question it aims to answer is:

•Does application of pharyngeal exerciser improve swallowing as evidenced by need for prescribed intervention for dysphagia (maneuvers, exercises or dietary modification to prevent aspiration).

Participants will:

Perform barium swallows in lateral view fluoroscopy
Over a six-week period, perform thrice daily sessions of swallowing with an external, laryngeal restriction device covering the larynx
Return for another fluoroscopic barium swallow study

详细描述

All the patients will be reviewed for inclusion and exclusion of the study in detailed manner using medical evaluation form. The physical examination part of the medical evaluation form will be filled out by one of our designated physician investigators. A urine pregnancy test will be administered if necessary at this time.

The patient's neck physical dimensions and device's physical dimensions will be measured and recorded using the Biometric form.

A baseline functional outcome assessment of swallowing (FOAMS) will be performed for each patient.

Patients will be sitting in an upright position with the head held in neutral position at Fluoroscopy lab and acclimatized for 10 minutes before proceeding.

Patient's anatomic structure and landmarks are identified in both lateral and anteroposterior (AP) views with fluoroscopy.

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: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Patients with dysphagia characterized by persistent pharyngeal residue on fluoroscopic study undergoing rehabilitative intervention (e.g.: exercises, maneuvers or dietary modification) for improving swallowing and preventing aspiration
•Healthy elderly adult (≥65 years of age).

排除标准

•Patients younger than 18 years of age.
•Patients with recent head and neck cancer (<1 month post-surgery or <3 months post-chemo radiation.
•Patients suffering from muscle diseases like muscular dystrophies, myopathies.
•Patients with neuro-muscular junction disorders myasthenia gravis, Eaton-Lambert disorders
•Patients having history of allergy to lidocaine or barium.
•Patients who are pregnant or lactating.
•Patients who are medically unstable.
•Patients who are unable to apply the exerciser independently or with the help of a caregiver.
•Patients who lack cognition.

研究组 & 干预措施

Pharyngeal exerciser group

Experimental

In this group, the device will be placed around the neck overlying the laryngeal cartilage. Patients are asked to follow exercise regimen: to perform 30 swallows at 15 seconds interval against minimal resistance of 20 mm Hg applied by pharyngeal exerciser over larynx during the first 2 weeks. This is repeated 3 times per day and the external resistance is increased every 2 weeks from 20 to 30 mm Hg and subsequently from 30 to 40 mm Hg in another 2 weeks.

干预措施: Pharyngeal exerciser (Device)

Sham exerciser group

Sham Comparator

In this group, sham device will be placed around the neck overlying the laryngeal cartilage. No external pressure will be applied during exercise. These patients will be asked to follow the exercise regimen: to perform repetitive tongue protrusion for 5 times without any pressure. This will be repeated 3 times a day for 6 weeks.

干预措施: sham pharyngeal exerciser (Device)