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

NCT04025112 | Unknown

• 1 other identifier: 1563/2018
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Breast cancer; Rehabilitation; Robotics

Outcome Measures

Primary Outcomes (4)

• 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"

Secondary Outcomes (1)

• Quality of life change

  "15 days" and "30 days"

Study Arms (2)

Armeo

EXPERIMENTAL

Patients group (54 patients) for robotic therapy.

Device: Armeo®Power

Conventional

ACTIVE COMPARATOR

Patients group (54 patients) for conventional rehabilitation protocol.

Other: Conventional rehabilitation protocol

Interventions

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.

Armeo

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.

Conventional

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Breast cancer in women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Bilateral surgery
• Radiotherapy treatment in progress
• Upper limb metastasis

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: July 18, 2019
• Study Start: July 20, 2019
• Primary Completion: July 30, 2020
• Study Completion: December 20, 2020
• Last Updated: July 18, 2019

Record last verified: 2019-04