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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105440
• Other study ID #: 41887715.0.0000.5503
• Status: Recruiting
• Phase: N/A
• First received: June 1, 2016
• Last updated: April 17, 2017
• Start date: January 2013
• Est. completion date: January 2019

Study information

• Verified date: March 2017
• Source: Universidade do Vale do Paraíba
• Contact: Izabela S. Mendes
• Phone: +55(12)39471000
• Email: izabela[@]univap.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: January 2019
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema
• Pain

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• Control group
Will participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer.

Locations

Country	Name	City	State
Brazil	University of Vale do Paraíba	São José dos Campos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema	Was measure thought perimetry.	10th. day.