Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional After Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Armeo®Power
* Other: Conventional rehabilitation protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Armeo<br>Patients group (54 patients) for robotic therapy. | Device: Armeo®Power<br>* 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.<br>|
| Active Comparator: Conventional<br>Patients group (54 patients) for conventional rehabilitation protocol. | Other: Conventional rehabilitation protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain classification change | 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 | Arm strength measure will be performed with a hand dynamometer. | 15 days and 30 days | 
| Change in the amplitude of arm movement | The amplitude of arm movement wil be measured by a goniometer. | 15 days and 30 days | 
| Upper limb disability change | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life change | Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire. | 15 days and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Rehabilitation, Robotics