Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional After Breast Cancer Surgery
2019年7月17日 更新者：Barretos Cancer Hospital
Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (预期的)
108
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Bilateral surgery
- Radiotherapy treatment in progress
- Upper limb metastasis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Armeo
Patients group (54 patients) for robotic therapy.
|
Randomized patients will be offered rehabilitation robotic using Armeo®Power from Hocoma, the first robotic arm exoskeleton for integrated arm and hand therapy, during one month, three times a week, totalizing 12 sessions of 45 minutes.
|
|
有源比较器：Conventional
Patients group (54 patients) for conventional rehabilitation protocol.
|
Randomized patients will be offered the conventional rehabilitation protocol from Barretos Cancer Hospital during one month, three times a week, totalizing 12 sessions of 45 minutes.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain classification change
大体时间："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).
|
"15 days" and "30 days"
|
|
Arm strength change
大体时间："15 days" and "30 days"
|
Arm strength measure will be performed with a hand dynamometer.
|
"15 days" and "30 days"
|
|
Change in the amplitude of arm movement
大体时间："15 days" and "30 days"
|
The amplitude of arm movement wil be measured by a goniometer.
|
"15 days" and "30 days"
|
|
Upper limb disability change
大体时间："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).
|
"15 days" and "30 days"
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life change
大体时间："15 days" and "30 days"
|
Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire.
|
"15 days" and "30 days"
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年7月20日
初级完成 (预期的)
2020年7月30日
研究完成 (预期的)
2020年12月20日
研究注册日期
首次提交
2019年4月22日
首先提交符合 QC 标准的
2019年7月17日
首次发布 (实际的)
2019年7月18日
研究记录更新
最后更新发布 (实际的)
2019年7月18日
上次提交的符合 QC 标准的更新
2019年7月17日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.