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临床试验/NCT06156397
NCT06156397已完成不适用

The Effect of Technological Based Rehabilitation Practices on Functional Parameters After Breast Cancer Surgery

Medipol University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Baseline Digital Goniometer

研究概览

简要总结

The aim is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

详细描述

Breast cancer is the most common malignant tumor in women. According to the World Health Organization's 2018 data, 11.6% of new cancers worldwide are breast cancer. The overall 5-year survival rates of stage I, II, and III patients are 98%, 92%, and 75%, respectively. Therefore, the survival rate is increasing due to developments in cancer treatment.

The incidence of shoulder mobility impairment after breast cancer surgery was 2% ~ 51%. Postoperative patients' failure to exercise due to fear of pain and affected wound healing leads to poor activity of the upper extremity and shoulder joints, which often leads to limited activity and dysfunction in the affected extremities.

The use of technology in rehabilitation is rapidly increasing, and new technologies provide more motivational participation of patients in their usual care and standard programs. It has been reported that in the acute period after mastectomy, shoulder pain, fatigue, decreased joint range of motion and muscle strength, neuropathy, and consequent limitation of daily living activities.

It has been proven that passive mobilization, general exercise, manual stretching and traditional physiotherapy practices combining them are effective in treating upper extremity pain and restoring functionality after surgery.

There is no study in the literature investigating the effect of an application-based physiotherapy program on upper extremity dysfunction in patients undergoing breast cancer surgery. The aim of this study is to investigate the effects of supervised exercise program, telerehabilitation program and mobile application supported exercise program, applied in the acute period after breast cancer surgery, on upper extremity dysfunction.

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
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being diagnosed with breast cancer and undergoing surgery and having axillary lymph node dissection performed during surgery
  • Finding the cases in the post-operative (post-op) 2nd week
  • Age range between 30 and 65 years
  • Limited shoulder ROM in preoperative evaluations absence
  • No speech or hearing problems
  • Patients included in the study are volunteers

排除标准

  • Previous ipsilateral or contralateral breast cancer surgery
  • Presence of active or metastatic cancer focus
  • A neurological disease that affects upper extremity functionality or
  • Finding orthopedic surgery
  • Having hearing or visual impairment
  • Carrying a pacemaker
  • Presence of infection and open wound
  • Finding a drain after surgery
  • Cases with mental and cooperation problems

研究组 & 干预措施

Standard Physiotherapy Exercise Group

Active Comparator

The exercise protocol will transition from simple to difficult as a result of literature research, and a standard exercise program will be applied, each session lasting 45 minutes.

干预措施: Standard Physiotherapy Exercise Group (Other)

Telerehabilitation Based Supervised Exercise Group

Active Comparator

Telerehabilitation exercise protocol exercises will last 45 minutes in total, transitioning from simple to difficult, and will be implemented with patients via Zoom.

干预措施: Telerehabilitation Based Supervised Exercise Group (Other)

Mobile Application Supported Exercise Group

Active Comparator

In the Mobile Application-Based exercise group, a virtual clinic will be created for the patients through the Becure application, and the patients will apply a gradual exercise program that will last approximately 45 minutes, determined by the physiotherapist, and the patients will be followed for 6 weeks through this application.

干预措施: Mobile Application Supported Exercise Group (Other)

结局指标

主要结局

Baseline Digital Goniometer

时间窗: six weeks

The initial and final shoulder range of motion (ROM) of the patients will be recorded in degrees using a digital goniometer. Shoulder ROM measurements will be measured bilaterally and using a standardized protocol.

次要结局

  • Tampa Kinesiophobia Scale (TKS)(six weeks)
  • Disability of Arm, Shoulder and Hand Questionnaire (DASH)(six weeks)
  • Visual Analog Scale (VAS)(six weeks)
  • The Functional Assessment of Cancer Therapy - Breast (FACT-B)(six weeks)
  • Muscle Strength Assessment(six weeks)
  • The Global Rating of Change (GRoC)(six weeks)
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)(six weeks)

研究者

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

Begüm Büyükerik

Student

Medipol University

研究点 (2)

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