Evaluation of a Structured Swallowing Rehabilitation Exercise Program on Dysphagia and Trismus in Head and Neck Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10)
研究概览
简要总结
This study aims to evaluate the effect of a structured swallowing rehabilitation program on swallowing function, trismus severity, and pain among patients with head and neck tumors, using a randomized controlled trial design. Eighty patients will be randomly allocated into two equal groups: a study group receiving the swallowing rehabilitation program and a control group receiving standard care.
详细描述
The swallowing rehabilitation program is a structured intervention designed to improve swallowing ability, mouth opening, and jaw mobility in patients with head and neck tumors. It includes the Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening, and jaw range-of-motion and stretching exercises, performed as three sets of ten repetitions twice daily. The program is delivered across four phases (assessment, planning, implementation, and evaluation) over structured orientation, theoretical, and practical sessions. Outcomes are assessed using the EAT-10 (swallowing function) and the Gothenburg Trismus Questionnaire 2 / GTQ2 (trismus severity), in addition to pain level, at baseline and 6 weeks after initiation of the program.
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)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Aged 20-60 years
- •Patients receiving chemoradiotherapy
- •Patients having a history of head and neck cancer
- •Patients who had received previous radiation therapy for head and neck cancer
排除标准
- •Patients who had neurological or psychiatric problems
- •Patients who had dysphagia for a reason other than cancer
研究组 & 干预措施
Swallowing Rehabilitation Program
Participants will receive a structured swallowing rehabilitation program including Mendelsohn maneuver, effortful swallow, Masako technique, tongue strengthening exercises, and jaw range-of-motion and stretching exercises. Exercises will be performed as three sets of ten repetitions, twice daily, delivered across orientation, theoretical, and practical sessions over four phases (assessment, planning, implementation, evaluation).
干预措施: Swallowing Rehabilitation Program (Behavioral)
Standard Care
Patients receive routine standard care with no structured rehabilitation program.
结局指标
主要结局
Change in Swallowing Function as Measured by the Eating Assessment Tool-10 (EAT-10)
时间窗: Baseline and 6 weeks after initiation of the swallowing rehabilitation program
Swallowing function assessed using the Eating Assessment Tool-10 (EAT-10), a 10-item self-administered questionnaire with total scores ranging from 0 to 40, with higher scores indicating greater swallowing difficulty (0-3 = normal swallowing, ≥4 = possible dysphagia, 10-20 = moderate dysphagia, \>20 = severe dysphagia).
次要结局
- Change in Trismus Severity as Measured by the Gothenburg Trismus Questionnaire 2 (GTQ-2)(Baseline and 6 weeks after initiation of the swallowing rehabilitation program)