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临床试验/NCT05680116
NCT05680116已完成不适用

The Effect of Wearable Vibration Therapy on Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery

Acibadem University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2023年2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
38
试验地点
1
主要终点
Muscle strength

研究概览

简要总结

The aim of our study is to investigate the effect of vibration therapy to be applied to patients undergoing breast cancer surgery and adjuvant radiotherapy on upper extremity joint range of motion, muscle strength, grip strength, pain, functionality, and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with breast cancer, undergoing breast-conserving surgery or having a total mastectomy and undergoing axillary lymph node dissection during surgery
  • Cases that will start radiotherapy after surgery
  • Being over 18 years old
  • Absence of limitation in shoulder joint range of motion in preoperative evaluations.
  • No speech and hearing problems
  • Volunteering of the patients included in the study

排除标准

  • Having previously undergone ipsilateral or contralateral breast cancer surgery
  • Presence of active or metastatic cancer focus
  • Presence of a neurological disease or orthopedic surgery affecting upper extremity functionality
  • Carrying a pacemaker
  • Presence of infection and open wound
  • Finding a post-surgical drain
  • Cases with mental and cooperation problems

结局指标

主要结局

Muscle strength

时间窗: 6 weeks

Hand-held dynamometer will be used to evaluate shoulder flexion, abduction, external and internal rotation muscles' strength

Range of motion

时间窗: 6 weeks

Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.

次要结局

  • Pain - Visual Analogue Scale(6 weeks)
  • Tone - Myoton® PRO(6 weeks)
  • Stiffness of Muscle- Myoton® PRO(6 weeks)
  • Grip strength(6 weeks)
  • Disability(6 weeks)
  • Quality of Life- Functional Assessment of Cancer Therapy-Breast" (FACT-B)(6 weeks)
  • Elasticity of Muscle -Myoton® PRO(6 weeks)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Feyzioğlu

Asistant Professor

Acibadem University

研究点 (1)

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