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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Armeo®Power
Conventional rehabilitation protocol
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Rehabilitation, Robotics

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Armeo

    Conventional

    Arm Description

    Patients group (54 patients) for robotic therapy.

    Patients group (54 patients) for conventional rehabilitation protocol.

    Outcomes

    Primary Outcome Measures

    Pain classification change
    Pain measure will be done through Shoulder Pain and Disability Index (SPADI) questionnaire, classifying it from 0 (low) to 100 (high).
    Arm strength change
    Arm strength measure will be performed with a hand dynamometer.
    Change in the amplitude of arm movement
    The amplitude of arm movement wil be measured by a goniometer.
    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).

    Secondary Outcome Measures

    Quality of life change
    Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire.

    Full Information

    First Posted
    April 22, 2019
    Last Updated
    July 17, 2019
    Sponsor
    Barretos Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04025112
    Brief Title
    Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional After Breast Cancer Surgery
    Official Title
    Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 20, 2019 (Anticipated)
    Primary Completion Date
    July 30, 2020 (Anticipated)
    Study Completion Date
    December 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Barretos Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Breast cancer, Rehabilitation, Robotics

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    108 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Armeo
    Arm Type
    Experimental
    Arm Description
    Patients group (54 patients) for robotic therapy.
    Arm Title
    Conventional
    Arm Type
    Active Comparator
    Arm Description
    Patients group (54 patients) for conventional rehabilitation protocol.
    Intervention Type
    Device
    Intervention Name(s)
    Armeo®Power
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Conventional rehabilitation protocol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain classification change
    Description
    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"
    Title
    Arm strength change
    Description
    Arm strength measure will be performed with a hand dynamometer.
    Time Frame
    "15 days" and "30 days"
    Title
    Change in the amplitude of arm movement
    Description
    The amplitude of arm movement wil be measured by a goniometer.
    Time Frame
    "15 days" and "30 days"
    Title
    Upper limb disability change
    Description
    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"
    Secondary Outcome Measure Information:
    Title
    Quality of life change
    Description
    Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire.
    Time Frame
    "15 days" and "30 days"

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Breast cancer in women
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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