Effect of Tongue-to-Palate Resistance Training on Penetration-Aspiration Scale and Suprahyoid Muscle Electrical Activity in Geriatric Patients With Oropharyngeal Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Penetration-Aspiration Scale (PAS) Score
研究概览
简要总结
The goal of this randomized controlled trial is to learn if a home-based Tongue-to-Palate Resistance Training (TPRT) program can improve swallowing muscle activity and swallowing safety in geriatric patients (aged >60 years) with oropharyngeal dysphagia. The main questions it aims to answer are:
- Does TPRT increase the electrical activity of the suprahyoid muscles (a key muscle group for swallowing) more than standard care?
- Does TPRT reduce scores on the Penetration-Aspiration Scale (PAS), a measure of swallowing safety, more than standard care?
- Researchers will compare the TPRT intervention group to the active control group to see if the simple, home-based TPRT exercise is as effective or more effective than standard hospital-based therapies.
Participants in the intervention group will:
Perform the TPRT exercise (pressing their tongue against the palate) for 30 repetitions, 5 times a week, for 8 weeks at home.
Be supported by a caregiver and use a video guide and logbook.
Participants in the control group will:
Receive standard hospital-based therapy twice a week, which may include Neuromuscular Electrical Stimulation (NMES) or biofeedback.
Perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home.
All participants will also receive education on safe swallowing techniques.
详细描述
Title: Effect of Tongue-to-Palate Resistance Training on Penetration-Aspiration Scale and Suprahyoid Muscle Electrical Activity in Geriatric Patients with Oropharyngeal Dysphagia: A Randomized Control Trial
Journal & Type: This is a manuscript for publication, presenting the results of a single-blind, randomized controlled trial (RCT).
Authors: The team is multi-disciplinary, consisting of experts in Internal Medicine, Physical Medicine and Rehabilitation (PM&R), and Radiology from Cipto Mangunkusumo Hospital/University of Indonesia, and a collaborator from Germany.
Background & Rationale:
Problem: Oropharyngeal dysphagia (difficulty swallowing) is a very common and serious problem in the elderly, leading to malnutrition, pneumonia from aspiration, and increased death rates.
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)
盲法说明
While the participants, care providers, and investigators involved in delivering the interventions were not masked due to the nature of the exercise-based interventions, the study maintained a single-blind design. The key masked party was the outcomes assessor. Specifically, the rehabilitation medicine physician who performed the surface electromyography (sEMG) measurements and the radiologist and rehabilitation medicine specialist who analyzed the videofluoroscopic swallowing study (VFSS) recordings were blinded to group allocation. This was implemented to ensure objective and unbiased assessment of the primary outcome measures (suprahyoid muscle electrical activity and Penetration-Aspiration Scale scores)
入排标准
- 年龄范围
- 61 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years with a diagnosis of oropharyngeal dysphagia based on history, physical examination, and Videofluoroscopic Swallowing Study (VFSS)
- •Initial measurement of suprahyoid muscle electrical activity ≤ 37.1 µV RMS
- •Has not undergone any other swallowing exercises or is not currently participating in any swallowing exercise program within the past 2 weeks.
- •Cooperative and willing to participate in the study by signing the informed consent form after receiving an explanation
- •Has a caregiver who is willing to participate and is cooperative to ensure the patient follows the exercise protocol according to the study.
排除标准
- •Cognitive impairment in the domains of memory, attention, or language based on the Montreal Cognitive Assessment - Indonesian version (MoCA-Ina), which would prevent the subject from following exercise instructions.
- •Presence of other conditions causing dysphagia, such as oral cavity malignancy, history of radical neck dissection, or history of chemoradiotherapy to the neck region less than 3 months after the last session.
- •Complete inability to move the tongue or initial suprahyoid muscle electrical activity measurement = 0 µV.
- •Allergy to barium, potato starch, corn starch, xanthan gum, dairy products, or latex.
- •Use of a pacemaker.
研究组 & 干预措施
Tongue-to-Palate Resistance Training (TPRT)
Participants in this arm performed a home-based Tongue-to-Palate Resistance Training (TPRT) program. The intervention consisted of pressing the tongue against the palate for 30 repetitions per session, five sessions per week, for a total of eight weeks. Participants were provided with video guidance and a logbook to record adherence, and were supported by a caregiver. This was a simple, device-free exercise regimen designed to strengthen the oropharyngeal and suprahyoid musculature.
干预措施: Tongue-to-Palate Resistance Training (Other)
Standard Dysphagia Therapy
Participants in this arm received the standard of care for oropharyngeal dysphagia. This included supervised, hospital-based sessions twice a week consisting of either Neuromuscular Electrical Stimulation (NMES) applied to the submental region or biofeedback swallowing therapy. Additionally, they were instructed to perform unsupervised Chin Tuck Against Resistance (CTAR) exercises at home. This arm represents the conventional, multi-modal rehabilitation approach against which the experimental TPRT intervention was compared.
干预措施: Standard Dysphagia Therapy (Combination Product)
结局指标
主要结局
Change in Penetration-Aspiration Scale (PAS) Score
时间窗: Baseline and Week 8
Change in swallowing safety as measured by the Penetration-Aspiration Scale (PAS). The PAS is an 8-point ordinal scale. The minimum score is 1 (no airway invasion) and the maximum score is 8 (aspiration of material into the airway with no reflexive response). A lower score on the PAS indicates a safer swallow and is a better outcome.
Change in Suprahyoid Muscle Electrical Activity
时间窗: Baseline, Week 4, and Week 8
The change in the electrical activity of the suprahyoid muscles (measured in microvolts root mean square, μV RMS) during a tongue press task and a dry swallow task. Measured using surface electromyography (sEMG).
次要结局
- Change in Pharyngeal Transit Time (PTT)(Baseline and Week 8)
- Change in Anterior Hyoid Excursion(Baseline and Week 8)
- Change in Superior Hyoid Excursion(Baseline and Week 8)
研究者
Melinda Harini
Dr. dr. Melinda Harini, Sp.K.F.R., Ger. (K)
Dr Cipto Mangunkusumo General Hospital