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

Barretos Cancer Hospital

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: Conventional rehabilitation protocol; Device: Armeo®Power

Study type: Interventional

Funder types: Other

Identifiers

NCT04025112

1563/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Armeo

Experimental group

Description:

Patients group (54 patients) for robotic therapy.

Treatment:

Device: Armeo®Power

Conventional

Active Comparator group

Description:

Patients group (54 patients) for conventional rehabilitation protocol.

Treatment:

Other: Conventional rehabilitation protocol