The Effect of Wearable Vibration Therapy on Shoulder Functionality in Individuals Receiving Adjuvant Radiotherapy After Breast Cancer Surgery
NCT ID: NCT05680116
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2023-02-01
2023-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Home based exercise group
Patients who will start radiotherapy after breast cancer surgery will be evaluated prior to treatment. During the radiotherapy process, all of the patients will be included in the home exercise program, 5 days a week, 2 sessions a day, each exercise will be 10x2 repetitions. Exercise follow-up of the patients will be provided with weekly routine face-to-face checks. After an average of 6 weeks of radiotherapy, the initial evaluations will be repeated.
Home based exercise
Patients will do home based exercise during the radiotherapy process. 5 days a week. 2 sessions a day, each exercise will be 10x2 repetitions
Home based exercise plus vibration therapy group.
Patients who will start radiotherapy after breast cancer surgery will be evaluated prior to treatment. During the radiotherapy process, all of the patients will be included in the home exercise program, 5 days a week, 2 sessions a day, each exercise will be 10x2 repetitions. The study group continues their home based exercise, in addition they will receive 30 minutes of Myovolt (Myovolt TM, Myovolt Limited, Christchurch, New Zealand) device which is wearable vibration therapy 2 days a week. The vibration program will continue for 6 weeks, in the form of 2 sessions per week. Intermittent and sinusoidal modes between 20-100 Hz will be used for the vibration frequency.
MYOVOLT (MyovoltTM, Myovolt Limited, Christchurch, New Zealand ) wearable vibration therapy device
Patients will wear Myovolt shoulder device twice a week and each session will continue 30minutes. This therapy will apply during the radiotherapy process. The device will be applied on the bare skin of the shoulder area. The first 10 minutes of the 30 minutes will be intermittent vibration, the other 20 minutes will be done in the sinusoidal vibration program. Both programs will be in the range of 20-100 Hz.
Interventions
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MYOVOLT (MyovoltTM, Myovolt Limited, Christchurch, New Zealand ) wearable vibration therapy device
Patients will wear Myovolt shoulder device twice a week and each session will continue 30minutes. This therapy will apply during the radiotherapy process. The device will be applied on the bare skin of the shoulder area. The first 10 minutes of the 30 minutes will be intermittent vibration, the other 20 minutes will be done in the sinusoidal vibration program. Both programs will be in the range of 20-100 Hz.
Home based exercise
Patients will do home based exercise during the radiotherapy process. 5 days a week. 2 sessions a day, each exercise will be 10x2 repetitions
Eligibility Criteria
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Inclusion Criteria
* Cases that will start radiotherapy after surgery
* Being over 18 years old
* Absence of limitation in shoulder joint range of motion in preoperative evaluations.
* No speech and hearing problems
* Volunteering of the patients included in the study
Exclusion Criteria
* Presence of active or metastatic cancer focus
* Presence of a neurological disease or orthopedic surgery affecting upper extremity functionality
* Carrying a pacemaker
* Presence of infection and open wound
* Finding a post-surgical drain
* Cases with mental and cooperation problems
18 Years
80 Years
FEMALE
No
Sponsors
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Acibadem University
OTHER
Responsible Party
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Özlem Feyzioğlu
Asistant Professor
Principal Investigators
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Özlem Feyzioğlu, PhD
Role: PRINCIPAL_INVESTIGATOR
Acibadem University
Locations
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Professor Cemil Taşcıoğlu Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Feyzioglu O, Dincer S, Yilmaz BD, Saldiran TC, Ozturk O. Effects of Vibration Therapy on Muscle Strength, Shoulder Range of Motion, and Muscle Biomechanical Properties in Patients With Breast Cancer Undergoing Radiotherapy: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2025 Apr 1;104(4):325-334. doi: 10.1097/PHM.0000000000002664. Epub 2024 Nov 14.
Other Identifiers
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ATADEK 2022-17/27
Identifier Type: -
Identifier Source: org_study_id