Breast Cancer
Conditions
Keywords
Breast cancer, Rehabilitation, Robotics
Brief summary
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
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.
Interventions
DEVICEArmeo®Power
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.
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.
Sponsors
Barretos Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain classification change | 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 | 15 days and 30 days | Arm strength measure will be performed with a hand dynamometer. |
| Change in the amplitude of arm movement | 15 days and 30 days | The amplitude of arm movement wil be measured by a goniometer. |
| Upper limb disability change | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life change | 15 days and 30 days | Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire. |
Outcome results
None listed