Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 主要终点
- Pain classification change
研究概览
简要总结
The aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. The study will be conducted following the delineation of randomized clinical trial. It will be assessed 108 women aged between 30 and 60 years, submitted to surgical treatment of breast cancer and axillary dissection.
详细描述
Breast cancer is one of the most common neoplasia types, with greater involvement in the female population, showing a high mortality rate in Brazil, due to diagnosis in advanced stages. With the increased survival of women treated for breast cancer, the evaluation of the effect of therapeutic resources for the morbidities resulting from surgical treatment of breast cancer are essential. The aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. The study will be conducted following the delineation of randomized clinical trial. It will be assessed 108 women aged between 30 and 60 years submitted to surgical treatment of breast cancer and axillary dissection, divided between two equal groups: control group (GC) - composed of women who had undergone conventional rehabilitation and experimental group (GE) - composed of women who had undergone rehabilitation robotics. The data obtained in the study aim to improve the forms of intervention against the functional alterations resulting from surgical treatment.
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
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women submitted to quadrantectomy, simple mastectomy, radical mastectomy or modified radical mastectomy with complete axillary dissection.
- •Women from 30 to 60 years old.
- •Postoperatory range from 20 to 80 days.
排除标准
- •Bilateral surgery
- •Radiotherapy treatment in progress
- •Upper limb metastasis
结局指标
主要结局
Pain classification change
时间窗: "15 days" and "30 days"
Pain measure will be done through Shoulder Pain and Disability Index (SPADI) questionnaire, classifying it from 0 (low) to 100 (high).
Arm strength change
时间窗: "15 days" and "30 days"
Arm strength measure will be performed with a hand dynamometer.
Change in the amplitude of arm movement
时间窗: "15 days" and "30 days"
The amplitude of arm movement wil be measured by a goniometer.
Upper limb disability change
时间窗: "15 days" and "30 days"
This outcome wil be measured by Disability of the Arm, Shoulder and Hand (DASH) questionnaire, classifying it from 0 (low) to 100 (high).
次要结局
- Quality of life change("15 days" and "30 days")