The Impact of Dysphagia Exercise on Oropharyngeal Swallowing Function in Patients With ALS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device
研究概览
简要总结
This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing. All participants will receive the treatment, and researchers will measure changes over time by comparing each person's results to their own earlier results.
People who join the study will have two in-person visits and four weekly telehealth sessions with a speech-language pathologist. During these sessions, participants will practice tongue resistance exercises, complete speech and swallowing tasks, and answer surveys about their experience. They will also use a small device at home to measure tongue strength and swallowing.
The exercise program involves pressing the tongue against a device several times a day, five days per week, for five weeks. Researchers want to learn if this program is safe, practical, and helpful for people with ALS.
详细描述
Study Timeline and Procedures In this within-subject repeated measures design, people with ALS (pALS) will serve as their own controls, enabling comparison of outcomes across multiple time points while accounting for interparticipant variability (i.e., disease heterogeneity). All participants will receive the intervention, and treatment-related changes will be evaluated relative to each individual's baseline performance.
Study participation will include two in-person evaluations (baseline and post-treatment), and five weekly telehealth therapy sessions. Outcome measures will be collected longitudinally to assess changes over time.
Each telehealth session will incorporate tongue isometric resistance training (maximum anterior tongue press) to ensure treatment fidelity. During these sessions, the following measures will be obtained: speaking rate using the Bamboo Passage (words per minute),the 3-ounce water swallow test to screen swallowing safety, and the Test of Masticating and Swallowing Solids (TOMASS) to assess swallowing efficiency. Patient-reported outcomes will include the Exercise Therapy Burden Questionnaire (ETBQ), EAT-10, and the ALS Functional Rating Scale (ALSFRS).
To facilitate home-based assessment of lingual strength and support exercise adherence, participants will be provided with a commercially available lingual manometer (Tongueometer), including protocols for maximum anterior tongue press and saliva swallow using lingual bulbs.
Screening/Baseline 1 (Week 0). Following consenting and screening procedures, study personnel will complete the initial baseline assessment procedures. Participants will complete the initial in-person baseline assessment in approximately 60-90 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited)
- •Lingual exercises naïve
- •Impaired lingual strength generation compared to normative data
- •EAT-10 score <3
排除标准
- •Head injury
- •Head and neck cancer
- •Tracheostomy
- •Other concomitant neurogenic disorder
- •Recent oral surgery other than routine dental surgery
- •Unable to generate isometric lingual pressure on lingual manometer
- •Participation in another clinical trial intervention that may confound results
- •NPO (nothing by mouth)
- •Anarthric
研究组 & 干预措施
Dysphagia Exercise Intervention
This study arm will test a proactive dysphagia exercise program using lingual manometry and isometric lingual strength training in people with ALS (pALS). The intervention is designed to maximize lingual strength, improve speech intelligibility, enhance swallow safety and efficiency, and support patient-reported swallowing and quality-of-life outcomes in individuals with minimal decline in tongue function.
干预措施: Isometric Lingual Strength Exercises (Procedure)
结局指标
主要结局
Maximum Anterior Isometric Lingual Pressure Measured Using the TongueMeter Device
时间窗: Participant will start using the tongue meter from day of enrollment. Baseline 1 : MAIP collected , Baseline 2: 5 weeks after baseline , then MAIP calculated at home , intensity of exercise set at 60% MAIP, 5 weeks of exercise at 60% MAIP
Measurement Tool: Lingual pressure is measured using the TongueMeter, a handheld, pressure-sensing device designed to quantify tongue strength during isometric tasks. A calibrated intraoral pressure sensor is positioned against the hard palate. Participants are instructed to press the tongue upward with maximal effort for a standardized duration, and the device records the resulting pressure output. Unit of Measure: Lingual strength is quantified as peak pressure, reported in kilopascals (kPa). Outcome Variable: The primary outcome is the maximum peak lingual pressure (kPa) achieved across trials, with higher values indicating greater lingual strength
Videofluoroscopic Swallow Study
时间窗: Baseline, Visit 1 (week 1), and Final Visit (week 10)swallowing safety/efficiency via DIGEST and PAS scores
This measure assesses swallowing safety and efficiency in participants using standardized VFSS trials. Safety is quantified using the Penetration-Aspiration Scale (PAS) to capture airway compromise, while swallowing efficiency is measured with the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST), which integrates residue severity and functional impact. Unit of Measure: PAS score for each swallow (ordinal 1-8) DIGEST grade for overall swallowing function (ordinal 0-4) Outcome Variable: The primary outcome is the frequency and severity of airway compromise (PAS) and overall dysphagia severity (DIGEST) during VFSS. Higher PAS and DIGEST scores indicate worse swallowing safety and efficiency.
次要结局
- EAT-10(From enrollment to the end of treatment at 10 weeks.)
- Test of Mastication and Swallowing Solids(From enrollment to the end of treatment at 10 weeks.)
- ALS Functional Rating Scale(From enrollment to the end of treatment at 10 weeks.)
- The Eating Tool Burden Questionnaire(To be given during at week 5 (baseline 2) and week 10 (final))
- Temporal Variability of Oral Diadochokinesis(From enrollment to the end of treatment at 10 weeks.)