Breast CancerNCT04025112
Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional After Breast Cancer Surgery
A study testing Armeo®Power and Conventional rehabilitation protocol in people with Breast Cancer, run by Barretos Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Armeo®Power and Conventional rehabilitation protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2019to 20 Dec 2020
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Bilateral surgery
- Radiotherapy treatment in progress
- Upper limb metastasis
About this study
Official title: Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer
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.
Read the detailed description
Breast cancer is one of the most common neoplasia types, with greater involvement in the female population, showing a high mortality rate in Brazil, due to diagnosis in advanced stages. With the increased survival of women treated for breast cancer, the evaluation of the effect of therapeutic resources for the morbidities resulting from surgical treatment of breast cancer are essential. 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, divided between two equal groups: control group (GC) - composed of women who had undergone conventional rehabilitation and experimental group (GE) - composed of women who had undergone rehabilitation robotics. The data obtained in the study aim to improve the forms of intervention against the functional alterations resulting from surgical treatment.
- Conditions
- Breast Cancer
- Being tested
- Armeo®Power, Conventional rehabilitation protocol
- Keywords
- Breast cancer, Rehabilitation, Robotics
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo®PowerDevice
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.
Conventional rehabilitation protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Armeo | Experimental | Patients group (54 patients) for robotic therapy. Receives: Device: Armeo®Power |
| Conventional | Active comparator | Patients group (54 patients) for conventional rehabilitation protocol. Receives: Other: Conventional rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain classification change
Pain measure will be done through Shoulder Pain and Disability Index (SPADI) questionnaire, classifying it from 0 (low) to 100 (high).
Measured: "15 days" and "30 days"
Arm strength change
Arm strength measure will be performed with a hand dynamometer.
Measured: "15 days" and "30 days"
Change in the amplitude of arm movement
The amplitude of arm movement wil be measured by a goniometer.
Measured: "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).
Measured: "15 days" and "30 days"
Secondary outcomes (1)
Quality of life change
Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire.
Measured: "15 days" and "30 days"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start20 Jul 2019 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025112
- Sponsor's protocol ID
- 1563/2018
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional in Postoperative Period of Patients Submitted to Surgical Treatment of Breast Cancer
- ClinicalTrials.gov ID
- NCT04025112
- Acronym / sponsor ID
- 1563/2018
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Rehabilitation, Robotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 20 Jul 2019 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 18 Jul 2019 (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 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.
Detailed description
Breast cancer is one of the most common neoplasia types, with greater involvement in the female population, showing a high mortality rate in Brazil, due to diagnosis in advanced stages. With the increased survival of women treated for breast cancer, the evaluation of the effect of therapeutic resources for the morbidities resulting from surgical treatment of breast cancer are essential. 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, divided between two equal groups: control group (GC) - composed of women who had undergone conventional rehabilitation and experimental group (GE) - composed of women who had undergone rehabilitation robotics. The data obtained in the study aim to improve the forms of intervention against the functional alterations resulting from surgical treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Armeo | Experimental | Device: Armeo®PowerPatients group (54 patients) for robotic therapy. |
| Conventional | Active comparator | Other: Conventional rehabilitation protocolPatients group (54 patients) for conventional rehabilitation protocol. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Bilateral surgery
- Radiotherapy treatment in progress
- Upper limb metastasis
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 |
|---|---|---|
| Armeo®PowerRandomized 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. | Device | Armeo |
| Conventional rehabilitation protocolRandomized 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. | Other | Conventional |
Primary outcome
Pain classification change
Time frame: "15 days" and "30 days"
Pain measure will be done through Shoulder Pain and Disability Index (SPADI) questionnaire, classifying it from 0 (low) to 100 (high).
Arm strength change
Time frame: "15 days" and "30 days"
Arm strength measure will be performed with a hand dynamometer.
Change in the amplitude of arm movement
Time frame: "15 days" and "30 days"
The amplitude of arm movement wil be measured by a goniometer.
Upper limb disability change
Time frame: "15 days" and "30 days"
This outcome wil be measured by Disability of the Arm, Shoulder and Hand (DASH) questionnaire, classifying it from 0 (low) to 100 (high).
1 secondary outcome
Quality of life change
Time frame: "15 days" and "30 days"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Armeo®Power and Conventional rehabilitation protocol in people with Breast Cancer, run by Barretos Cancer Hospital.
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 3 inclusion and 3 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain classification change (time frame: "15 days" and "30 days"). The study lists 4 primary outcomes in all. 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 18 Jul 2019.