Innovation Oncological Rehabilitation: Applicability of the Different Techniques Physiotherapeutic Post Breast Cancer

The aim of this study is to evaluate the effects and validate news physiotherapy techniques: robotic rehabilitation, virtual reality, vibration therapy, canoeing and hand cycling in the secondary clinical complications of the breast cancer, through the Biomedical Instrumentation. It will be realized the double-blind longitudinal clinical study. Will participate in the study 100 women post breast cancer surgery, the volunteers will be allocated in the respective modalities treatment; and 20 healthy volunteers, will be only the control group. The volunteers conducted 10 physiotherapy session, and it will be evaluated after, during and before of the treatment, to evaluated myoelectric activity, scapular and hand muscle strength, range of motion, circumference of the upper limbs and quality of life. Expected to Positive Results With regard to the minimization of pain intensity and lymphedema, favoring the improvement of range of motion of the shoulder joint, myoelectric activity, increased muscle strength, and consequently improves the quality of life.

Study Overview

• Status: Unknown
• Conditions: Pain; Lymphedema
• Intervention / Treatment: Other: Robotic rehabilitation; Other: Virtual reality; Other: Vibration therapy; Other: Hand cycling; Other: Control group; Other: Canoeing

Detailed Description

The brest cancer is considered a public health problem worldwide. In Brazil, there was increased survival due to advances in early diagnosis and the therapeutic approaches each more accurate and effective, however these women require care and attention for short and long time, due to the consequences physical and psychosocial, que undertake their quality of life. The innovative techniques physiotherapy treatment can contribute to the prevention and treatment of complications, with the intention to facilitate the early return of women to their daily activities. The aim of this study is to evaluate the effects and validate news physiotherapy techniques: robotic rehabilitation, virtual reality, vibration therapy, canoeing and hand cycling in the secondary clinical complications of the breast cancer, through the Biomedical Instrumentation. It will be realized the double-blind longitudinal clinical study. Will participate in the study 100 women post breast cancer surgery, the volunteers will be allocated in the respective modalities treatment; and 20 healthy volunteers, will be only the control group. The volunteers conducted 10 physiotherapy session, and it will be evaluated after, during and before of the treatment, to evaluated myoelectric activity, scapular and hand muscle strength, range of motion, circumference of the upper limbs and quality of life. Expected to Positive Results With regard to the minimization of pain intensity and lymphedema, favoring the improvement of range of motion of the shoulder joint, myoelectric activity, increased muscle strength, and consequently improves the quality of life.

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Izabela S. Mendes; Phone Number: 2066 +55(12)39471000; Email: izabela@univap.br

Study Locations

• Brazil
  • SP
    • São José dos Campos, SP, Brazil, 12244-000
      • Recruiting
      • University of Vale do Paraiba
      • Contact: Izabela S. Mendes; Phone Number: +55(12) 39471000; Email: izabela@univap.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Conservative or non-conservative breast cancer surgery;
• Acceptance of the Informed Consent.

Exclusion Criteria:

• Patients who still have chest drain;
• Volunteers who need any aiding device to remain in orthostatism;
• Patients don't accepted of the Informed Consent;
• Patients who ar afraid of water.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic rehabilitation; It Will be used a exoskeleton Armeo®Spring, to training to affected upper limb, the protocol of the treatment is constituted for 8 games. The equipment arm will be adjusted the volunteers height, in sitting position, allowing support against the action of gravity of the arm and forearm, supporting 45° of the shoulder flexion, which will be facilitation the member movement.	Other: Robotic rehabilitation; It Will be used a exoskeleton Armeo®Spring, to training to affected upper limb, the protocol of the treatment is constituted for 8 games. The equipment arm will be adjusted the volunteers height, in sitting position, allowing support against the action of gravity of the arm and forearm, supporting 45° of the shoulder flexion, which will be facilitation the member movement.
EXPERIMENTAL: Virtual reality; The software used in this study was developed by the members of the Laboratory of Sensory and Motor Engineering Rehabilitation Together with Federal University of Uberlândia. This virtual reality of projection software, which uses Kinact®, captures the patient's picture and transfers to the monitor. The exercises provided by game are similar to those performed in conventional therapy; however, in a more entertaining form. Comprised 8 exercises to upper limbs and trunk. The patient should reach the red circle until it becomes green.	Other: Virtual reality; This virtual reality of projection software, which uses Kinact®, captures the patient's picture and transfers to the monitor. The exercises provided by game are similar to those performed in conventional therapy; however, in a more entertaining form. Comprised 8 exercises to upper limbs and trunk. The patient should reach the red circle until it becomes green.
EXPERIMENTAL: Vibration therapy; The vibration mat used in this study was developed by the members of the Laboratory of Sensory and Motor Engineering Rehabilitation together with mark Vibra Ind. e Com. Prod. Electronics Ltda. Will participate 20 woman, that stay in supine position, with the enveloped member of the vibration mat, elevated and supported. The volunteer will be submitted to 15 minutes of vibration with frequency of the 40 hertz, in both upper limbs.	Other: Vibration therapy; The vibration mat used in this study was developed by the members of the Laboratory of Sensory and Motor Engineering Rehabilitation together with mark Vibra Ind. e Com. Prod. Electronics Ltda. Will participate 20 woman, that stay in supine position, with the enveloped member of the vibration mat, elevated and supported. The volunteer will be submitted to 15 minutes of vibration with frequency of the 40 hertz, in both upper limbs.
EXPERIMENTAL: Hand cycling; Will participate 20 woman, submitted hand cycling through of the adapted bicycle to upper members. The protocol will be comprised by track without obstacle, comprised by 10 turns. The cyclic movement velocity will be realized according to the physical fatigue of patients.	Other: Hand cycling; Will participate 20 woman, submitted hand cycling through of the adapted bicycle to upper members. The protocol will be comprised by track without obstacle, comprised by 10 turns. The cyclic movement velocity will be realized according to the physical fatigue of patients.
EXPERIMENTAL: Control group; Will participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer.	Other: Control group; Will participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer.
EXPERIMENTAL: Canoeing; Will participate 20 woman, submitted canoeing activates, through rowing realized in therapeutic pool, with the aid and supervision of the therapeutic. It is important highlight that the exercises intensity will be to realized according to the physical fatigue of patients.	Other: Canoeing; Will participate 20 woman, submitted canoeing activates, through rowing realized in therapeutic pool, with the aid and supervision of the therapeutic. It is important highlight that the exercises intensity will be to realized according to the physical fatigue of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edema	Was measure thought perimetry.	10th. day.

Collaborators and Investigators

• Sponsor: Universidade do Vale do Paraíba
• Investigators: Study Director: Izabela S. Mendes, Universidade do Vale do Paraíba

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: June 1, 2016
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: breast cancer; pain; rehabilitation; lymphedema; range of motion; technologic innovation
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 41887715.0.0000.5503

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO