Effect of Myofunctional therapy on mouth opening, quality of life and sleep quality in post operative oral cancer patients A randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Mouth opening ( THERABITE device)
研究概览
简要总结
Oropharyngeal exercise
Oropharyngeal exercises regime is divided into three phases:
Phase 1 included :- 4 lip exercises, 5 tongue exercises, 2 jaw exercises, and 2 soft palate exercises. ( 10 days) 10 reps 3 times a day .
Phase 2 included :- 2 lip exercises, 2 tongue exercises, 2 jaw exercises, 5 soft palate exercises, and 2 cheek exercises.( 10 days) 10 reps 5 times a day.
Phase 3 included :- 2 lip exercises, 2 tongue exercises, 1 jaw exercises, and 2 soft palate exercises.( 10 days) 10 reps 5 times a day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both genders.
- •Age group 18-75 years of age.
- •Patient with histopathologically proven oral or oropharyngeal squamous cell carcinoma.(oral cavity, oropharynx, nasopharynx, salivary gland, nasal fossae).
- •Patient who are operatied for an en bloc resection of primary tumor, neck dissection and reconstruction.
- •Patient who is receiving post operative chemotherapy.
- •Difficulty in mouth opening.
- •Patient with sleep disturbed.
排除标准
- •Neurological (facial palsy, cognitive impairment, Alzheimer,senile dementia) or other non tumor related swallowing difficulty.
- •Risk of fracture, respiratory insufficiency (grade3)
- •Intense pain not controlled with analgesic treatment.
- •Bone metastasis with risk of fracture.
- •Patients who are on corticosteroid for more than one month.
- •Psychological reason that could hamper adherence with study protocol.
- •Patient with difficulty with completing questionnaires.
- •Intubated post operative patients.
结局指标
主要结局
1. Mouth opening ( THERABITE device)
时间窗: Before and after 0f 4 week intervention
2. Quality of life (university of Washington quality of life)
时间窗: Before and after 0f 4 week intervention
次要结局
- 1. Subjective sleep quality.(PSQI and consensus sleep diary)(Before and after 0f 4 week intervention)
研究者
Sumeet Nandkumar Keode
MGM institute of physiotherapy Aurangabad