Effects of Proprioceptive Neuromuscular Facilitation and Chin Tuck Against Resistance Exercises on Swallowing Function in Patients With Multiple Sclerosis and Dysphagia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score
研究概览
简要总结
This study compares two exercise programs for people with multiple sclerosis (MS) who have trouble swallowing. One group did chin exercises against resistance (CTAR), and the other group did neck exercises based on a technique called proprioceptive neuromuscular facilitation (PNF). Both groups also received a sensory technique to help trigger swallowing.
The study tested whether these exercises could improve swallowing ability, swallowing speed, and quality of life related to eating and drinking. Participants were randomly assigned to one of the two exercise groups and were treated for 8 weeks, three times per week. Swallowing was assessed before and after treatment using validated questionnaires and a water-swallow test.
详细描述
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system that frequently causes dysphagia (swallowing difficulty), which can lead to aspiration pneumonia and reduced quality of life. Exercise-based interventions targeting the suprahyoid and infrahyoid muscles are commonly used in dysphagia rehabilitation, but comparative evidence between Chin Tuck Against Resistance (CTAR) exercises and cervical Proprioceptive Neuromuscular Facilitation (PNF) exercises in MS patients is lacking.
This randomized, controlled, single-blind (outcome assessor blinded) trial enrolled adults aged 18-65 with a confirmed diagnosis of MS (per 2017 McDonald criteria), a DYMUS score ≥1, and no relapse in the preceding 6 months. Participants were allocated 1:1 to either the CTAR group or the PNF group using a computer-generated randomization sequence (minimization method, balanced for sex and disease course), with allocation concealed via sequentially numbered, sealed, opaque envelopes.
Both groups received Thermal-Tactile Stimulation (TTS) as a shared baseline treatment. The CTAR group performed isometric chin-tuck exercises against a resistance ball (2-3 sets x 8-12 repetitions per session). The PNF group performed cervical combined isotonic contraction techniques using diagonal movement patterns (30 repetitions per session). Both groups trained 3 sessions per week for 8 weeks (24 sessions total), with total session duration equalized between groups (approximately 30 minutes, including rest periods and TTS).
The primary outcome was change in DYMUS total score from baseline to week 8. Secondary outcomes included the Eating Assessment Tool (EAT-10), 100 mL Water Swallow Test parameters (swallowing duration, speed, and volume), the Functional Oral Intake Scale (FOIS), and the Swallowing Quality of Life Questionnaire (SWAL-QOL). Adverse events related to exercise (pain, fatigue, choking sensation) were systematically monitored at each session
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
The outcome assessor was a physiotherapist not involved in intervention delivery and unaware of group allocation. Participants were asked not to disclose their group assignment during assessment sessions
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Confirmed diagnosis of multiple sclerosis according to the 2017 McDonald criteria
- •DYMUS (Dysphagia in Multiple Sclerosis) questionnaire score ≥1
- •Age between 18 and 65 years
- •No relapse within the preceding 6 months
排除标准
- •- Pregnancy or breastfeeding
- •Presence of another neurological disease that could cause dysphagia
- •Presence of pneumonia
- •History of head-neck surgery or head-neck cancer
- •Persistent neck pain and/or radiculopathy
- •Inadequate head control
- •Inability to understand or follow verbal commands
结局指标
主要结局
Change in DYMUS (Dysphagia in Multiple Sclerosis Questionnaire) Total Score
时间窗: Baseline and week 8 (post-treatment)
The DYMUS is a 10-item self-report questionnaire assessing oropharyngeal dysphagia in multiple sclerosis patients, scored 0 (no) to 1 (yes) per item, yielding a total score range of 0-10. Higher scores indicate greater dysphagia severity. A score ≥3 indicates severe swallowing difficulty.
次要结局
- Change in EAT-10 (Eating Assessment Tool-10) Score(Baseline and week 8)
- Change in FOIS (Functional Oral Intake Scale) Level(Baseline and week 8)
- Change in SWAL-QOL (Swallowing Quality of Life) Score(Baseline and week 8)
- Change in 100 mL Water Swallow Test Parameters (Swallowing Speed, Volume per Swallow, Duration)(Baseline and week 8)
研究者
Hakan Polat
dırector
Sanko University