An interventional study of Armeo®Power and Conventional rehabilitation protocol in Breast Cancer, sponsored by Barretos Cancer Hospital. Status unknown. Open to female participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-07-18.
Sponsored by Barretos Cancer Hospital · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 108 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Barretos Cancer Hospital is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients group (54 patients) for robotic therapy.
Device: Armeo®Power
Patients group (54 patients) for conventional rehabilitation protocol.
Other: Conventional rehabilitation protocol
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.
Pain classification change
Pain measure will be done through Shoulder Pain and Disability Index (SPADI) questionnaire, classifying it from 0 (low) to 100 (high).
Time frame: "15 days" and "30 days"
Arm strength change
Arm strength measure will be performed with a hand dynamometer.
Time frame: "15 days" and "30 days"
Change in the amplitude of arm movement
The amplitude of arm movement wil be measured by a goniometer.
Time frame: "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).
Time frame: "15 days" and "30 days"
Quality of life change
Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire.
Time frame: "15 days" and "30 days"
No study locations are listed for this record.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Barretos Cancer Hospital