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临床试验/NCT03545100
NCT03545100已完成不适用

Rehabilitation Outcomes of Shoulder Function in Oral Cancer Survivors Cancer Survivors

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
shoulder function

研究概览

简要总结

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors.

详细描述

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Advanced treatment of oral cancer increases survival rates; however, it also increases the risk of developing shoulder dysfunction, dysphagia, oral dysfunction, donor site morbidity and psychological issues. The probability of shoulder dysfunction after neck dissection is as high as 70%. Rehabilitation effects on shoulder function for head and neck survivors are needed for further studied.

The purpose of this randomized clinical trial is to explore the effects of rehabilitation for shoulder function in oral cancer survivors. We will recruit 60 newly diagnosed oral cancer subjects through the plastic surgeon's referral from April 2018 to March 2020. The participants will be randomized separated into experimental or control group. Each group would receive regular physical therapy for shoulder function (i.e., transcutaneous electrical stimulation, shoulder joint range of motion exercise, scapular muscle strengthening training). Experimental group would be supplemented by motor control therapy targeting the scapular muscle progressive resistance exercise (exercise plus manual therapy).

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 (Participant)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willing to sign the inform consent
  • Sufficiently communicate in the Chinese language
  • Be able to follow instructions
  • Newly diagnosed oral cancer
  • Spinal accessory shoulder dysfunction

排除标准

  • Pregnant or breast-feeding woman
  • Cognitively impaired
  • Central nervous disease
  • Distant metastasis or recurrence
  • A history of shoulder pain or known shoulder pathology
  • Unable to communicate or comprehend the questionnaires

结局指标

主要结局

shoulder function

时间窗: 1 year

the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure for upper extremity function

maximal isometric muscle strength

时间窗: 1 year

measurement for the upper trapezius, middle trapezius, lower trapezius and serrates anterior at the moment of SEMG

shoulder joint range of motion

时间窗: 1 year

abduction measured by goniometer

shoulder pain

时间窗: 1 year

Visual Analog Scale, the \*total\* range = 0-10

次要结局

  • quality of life H&N35(1 year)
  • surface electromyography (SEMG)(1 year)
  • return to work(1 year)
  • quality of life C-30(1 year)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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