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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Armeo | Experimental | Patients group (54 patients) for robotic therapy. |
|
| Conventional | Active Comparator | Patients group (54 patients) for conventional rehabilitation protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armeo®Power | Device | 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. |
| 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" |
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
Breast cancer in women
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Conventional rehabilitation protocol | Other | 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. |
|
| D017437 |
| Skin and Connective Tissue Diseases |