Comparison Between Isometric Lingual Strengthening Exercises and Standard Clinical Care for the Treatment of Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 18
- 主要终点
- Change in Swallow Function
研究概览
简要总结
This study is a multisite, randomized clinical trial to determine the effectiveness of an 8-week rehabilitative exercise regime performed by patients with swallowing problems, termed dysphagia, compared to a control group of patients with swallowing problems who do not exercise, but receive standard clinical care. One hundred male and female patients will take part in this study from eight participating facilities around the country.
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
- None
入排标准
- 年龄范围
- 21 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referral by a physician for swallowing evaluation because of suspected dysphagia
- •complaint of difficulty swallowing
- •aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR post-swallow residue visible in the oral cavity, valleculae, or pharynx that is instrumentally documented by a participating SLP during a standard clinical videofluoroscopic swallowing study
- •between the ages of 21 and 95
- •ability to perform the exercise protocol independently or with the assistance of a caregiver
- •physician approval of medical stability to participate
- •decision-making capacity to provide informed consent (confirmed through discussion between the participating SLP and the subject's primary physician)
排除标准
- •degenerative neuromuscular disease
- •poorly controlled psychosis
- •patient unable to complete the exercise program
- •allergy to barium (used in videofluoroscopic swallowing assessment)
结局指标
主要结局
Change in Swallow Function
时间窗: Baseline and 8 Weeks
The Primary Outcome will be objectively measured from videofluoroscopic images. Improvement in swallowing is defined as a reduction in either the average Penetration/Aspiration scale score or the average Residue Scale score over the 11 swallows (3 3-ml thin liquid, 3 10-ml thin liquid, 3 3-ml semi-solid and 2 3-ml thin liquid effortful) combined with no increase in the other average score. If the series of swallows is terminated prematurely, the worst possible score (8 for Penetration/Aspiration Scale, 2 for residue) will be assigned for all uncompleted swallows.
次要结局
- Change in Penetration/Aspiration Scale score(Baseline and Week 8)
- Change in Bolus Transit Times(Baseline and 8 Weeks)
- Change in Isometric Lingual Pressure(Baseline and 8 Weeks)
- Change in Quality of Life(Baseline and 8 Weeks)
- Change in Residue Scale score(Baseline and Week 8)