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

NCT ID: NCT03105440

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2019-01-31

Brief 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.

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.

Conditions

Lymphedema; Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Robotic rehabilitation

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Vibration therapy

Intervention Type: OTHER

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.

Group Type: EXPERIMENTAL

Hand cycling

Intervention Type: OTHER

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.

Control group

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

Group Type: EXPERIMENTAL

Control group

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Canoeing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Control group

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Vale do Paraíba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Izabela S. Mendes

Role: STUDY_DIRECTOR

Universidade do Vale do Paraíba

Locations

University of Vale do Paraíba

São José dos Campos, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Izabela S. Mendes

Role: CONTACT

izabela@univap.br

+55(12)39471000 ext. 2066

Facility Contacts

Izabela S. Mendes

Role: primary

izabela@univap.br

+55(12) 39471000

Other Identifiers

41887715.0.0000.5503

Identifier Type: -

Identifier Source: org_study_id