LymphedemaNCT03105440
Innovation Oncological Rehabilitation: Applicability of the Different Techniques Physiotherapeutic Post Breast Cancer
A study testing Virtual reality, Vibration therapy and Hand cycling in people with Lymphedema and Pain, run by Universidade do Vale do Paraíba at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Lymphedema, Pain
- What is being tested?
- Virtual reality, Vibration therapy and Hand cycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Conservative or non-conservative breast cancer surgery;
- Acceptance of the Informed Consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Vale do Paraíba
São José dos Campos, São Paulo, 12244-000
Izabela S. Mendes, +55(12) 39471000, izabela@univap.br
About this study
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.
Read the 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
- Being tested
- Virtual reality, Vibration therapy, Hand cycling, Canoeing, Robotic rehabilitation
- Keywords
- breast cancer, lymphedema, pain, range of motion, technologic innovation, rehabilitation
- Medical subject headings
- Lymphedema, Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
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 therapyOther
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 cyclingOther
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.
CanoeingOther
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 rehabilitationOther
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 groupOther
Will participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Robotic rehabilitation | Experimental | 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. Receives: Other: Robotic rehabilitation |
| Virtual reality | Experimental | 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. Receives: Other: Virtual reality |
| Vibration therapy | Experimental | 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. Receives: Other: Vibration therapy |
| Hand cycling | Experimental | 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. Receives: Other: Hand cycling |
| Control group | Experimental | Will participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer. Receives: Other: Control group |
| Canoeing | Experimental | 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. Receives: Other: Canoeing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema
Was measure thought perimetry.
Measured: 10th. day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startJan 2013
- Primary completionApr 2017
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izabela S. Mendes, Study director, Universidade do Vale do Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105440
- Sponsor's protocol ID
- 41887715.0.0000.5503
- Status last verified
- Mar 2017
- First submitted
- 1 Jun 2016
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation Oncological Rehabilitation: Applicability of the Different Techniques Physiotherapeutic Post Breast Cancer
- ClinicalTrials.gov ID
- NCT03105440
- Acronym / sponsor ID
- 41887715.0.0000.5503
- Conditions
- Lymphedema, Pain
- Keywords
- breast cancer, lymphedema, pain, range of motion, technologic innovation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Universidade do Vale do ParaíbaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jan 2019 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Robotic rehabilitation | Experimental | Other: Robotic rehabilitationIt 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 | Experimental | Other: Virtual realityThe 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. |
| Vibration therapy | Experimental | Other: Vibration therapyThe 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 | Experimental | Other: Hand cyclingWill 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 | Experimental | Other: Control groupWill participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer. |
| Canoeing | Experimental | Other: CanoeingWill 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Conservative or non-conservative breast cancer surgery;
- Acceptance of the Informed Consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityThis 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 |
| Vibration therapyThe 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 |
| Hand cyclingWill 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 |
| CanoeingWill 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 |
| Robotic rehabilitationIt 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 |
| Control groupWill participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer. | Other | Control group |
Primary outcome
Edema
Time frame: 10th. day.
Was measure thought perimetry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Izabela S. Mendes study director
Universidade do Vale do Paraíba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality, Vibration therapy and Hand cycling in people with Lymphedema and Pain, run by Universidade do Vale do Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Izabela S. Mendes (+55(12)39471000 ext. 2066, izabela@univap.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema (time frame: 10th. day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.