Breast CancerNCT03618433
KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery
A study testing study group in people with Breast Cancer and Upper Extremity Dysfunction, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of the study is to investigate the effects of Kinect® video based technology on pain, functionality, muscle strength, fatigue and quality of life in patients with breast cancer surgery and axillary node dissection. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Breast Cancer, Upper Extremity Dysfunction, Mastectomy
- What is being tested?
- study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2018to 5 Aug 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with breast cancer and having axillary lymph node dissection,
- Post -operative in two weeks,
- VAS score>1,
- Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence)
- Women who have read, understood and signed informed consent freely
Who cannot join
- Patients who had breast cancer surgery contralateral or the same side before
- active or metastatic cancer centers
- a neurological condition or orthopedic surgery that affects upper extremity function
- pacemaker, infection, open wound,
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Okemeydanı Training and Research Hospital
Istanbul
About this study
The main objective of the study is to investigate the effects of Kinect® video based technology on pain, functionality, muscle strength, fatigue and quality of life in patients with breast cancer surgery and axillary node dissection.
Read the detailed description
Introduction: Breast cancer is the most common cancer seen in women. 1.7 million new cases have been reported in the world and have been shown as the fifth cause of death among women.There are many risk factors in etiogenesis, including gender, family history, age, obesity, malnutrition in postmenopausal period, hormone therapy, after 30 years of first birth, alcohol consumption and physical activity inadequacy. Pain and functional disorders are common complications after post-mastectomy in upper extremity. After mastectomy surgery ,pain in the shoulder, fatigue, decrease in range of motion, restriction of daily living activities, decrease of muscle strength, postural inbalance,, neuropathy and lymphedema may occur in the acute and chronic period.
Patients with breast cancer need a multidisciplinary and ongoing physiotherapy program.New technologies provide more motivational involvement for patients according to regular care and standard programs. Microsoft Kinect® is a virtual exercise program that is an application. It has been in use for rehabilitation among physical therapists for different deseas.The Kinect® application is a special technological approach that allows to follow the movements of the body. Microsoft Kinect® virtuel reality video games are promissing rehabilitation options because they involve upper extremity practise.
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to two groups:
Experimental group- where the participants will be treated with standart exercise therapy and Kinect® video-game-based technology
Control Group - Standart exercise therapy and upper extremity rehabilitation-oriented physiotherapy program will be applied.
The evaluations will be repeated at the beginning of the study and at the end of the sixth week. Data obtained from the study will be analyzed using appropriate statistical methods. Patients will be received to therapy which upper extremity rehabilitation or Kinect based video game play under physiotherapist supervision for two days a week for six weeks. Patients will be supported by the home exercise program, except during sessions. Participants' joint range of motion in the initial assessments will be measured by electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate evaluation positions and grip force asssessment by Saehan Hydraulic Hand Dynamometer . In assessing pain, pain levels at rest and during activity will be questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via Disabilities of the Arm Shoulder and Hand Anketi (DASH). Environmental measurement differences between upper extremities with and without operation will be assessed with made in the arm, forearm and the wrist. In assessing Quality of life will be assessed European Organization for Research and Treatment of Cancer EORTC QLQ-C30 - EORTC- BR23 and finally fatique of individuals will be assessed via Cancer Fatigue Scale -CFS.
Sample size: 17 women for each group. Data Analysis:Data obtained from the study will be analyzed using appropriate statistical methods.
- Conditions
- Breast Cancer, Upper Extremity Dysfunction, Mastectomy
- Being tested
- study group, Control group
- Keywords
- kinect, breast cancer, mastectomy, upper extremity dysfunction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study groupOther
Also called Kinect based therapy and standart exercise
The treatment protocol will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises. and shoulder proprioception .In addition to the standart exercise therapy, Kincet® video game program will be applied .
Control groupOther
Also called Standart exercise and upper extremity rehabilitation
The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Standart exercise protocol and KİNECT® video based physiotherapy
The treatment protocol of the study group will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises.In total, a 25-minute Kincet® video game program will be applied in addition to the 15-minute basic and standart exercise program. Receives: Other: study group |
| Control group | Active comparator | Standart exercise protocol and Upper extremity rehabilitation
The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.
Measured: 6 weeks
Secondary outcomes (5)
Pain - Visual Analogue Scale-
Visual Analogue Scale is one of the simple and common methods used in pain assessment. Self reported pain intensity during the rest and the activity measured by 0-10 centimeter chart. Visual Analogue Scale (VAS), where 0 indicates no pain or best and 10 indicates the most intense pain imaginable or worst. The patient will mark the severity of the pain on a 10 cm long chart.
Measured: 6 weeks
Muscle strength
Hand-held dynamometer will be used to evaluate shoulder muscles' strength
Measured: 6 weeks
Circumference
Upper arm circumference (millimeters) was measured to the nearest millimeter with a steel tape. Measurement will be made wrist, with 10 cm proximal of the wrist, at the lateral epicondyle, and 10 cm proximal of the elbow while arm hanging relaxed.
Measured: 6 weeks
Grip strength
Grip strength was evaluated by hand grip dynamometry (Saehan Hydraulic Hand Dynamometer ) Measurements were performed in affected side according to positions defined by American Society of Hand Therapists (sitting with the shoulder adducted to the side and the elbow flexed 90° with the forearm and wrist in the neutral mid-position)
Measured: 6 weeks
Fatigue
The Cancer Fatique scale (CFS) will be used to evaluate fatique. The cancer fatigue scale (CFS) was developed for the purpose of identifying and measuring fatigue in cancer patients, and its validity was evaluated in cancer patients and also in a scale determined specifically in breast cancer cases.The scale consists of 15 items and three subscales; physical, affective, and cognitive. Each item is scored between 1 and 5. 1 is never asked, 5 is too much.The high score indicates the excess of fatigue severity.The maximum total score is 60.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start3 Sep 2018
- Primary completion1 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Feyzioğlu, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618433
- Sponsor's protocol ID
- ATADEK-2018 / 9
- Status last verified
- Nov 2019
- First submitted
- 30 Jul 2018
- Last updated
- 14 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feyzioglu O, Dincer S, Akan A, Algun ZC. Is Xbox 360 Kinect-based virtual reality training as effective as standard physiotherapy in patients undergoing breast cancer surgery? Support Care Cancer. 2020 Sep;28(9):4295-4303. doi: 10.1007/s00520-019-05287-x. Epub 2020 Jan 6.
PubMed 31907649
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03618433
- Acronym / sponsor ID
- ATADEK-2018 / 9
- Conditions
- Breast Cancer, Upper Extremity Dysfunction, Mastectomy
- Keywords
- kinect, breast cancer, mastectomy, upper extremity dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 7 Aug 2018 (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 main objective of the study is to investigate the effects of Kinect® video based technology on pain, functionality, muscle strength, fatigue and quality of life in patients with breast cancer surgery and axillary node dissection.
Detailed description
Introduction: Breast cancer is the most common cancer seen in women. 1.7 million new cases have been reported in the world and have been shown as the fifth cause of death among women.There are many risk factors in etiogenesis, including gender, family history, age, obesity, malnutrition in postmenopausal period, hormone therapy, after 30 years of first birth, alcohol consumption and physical activity inadequacy. Pain and functional disorders are common complications after post-mastectomy in upper extremity. After mastectomy surgery ,pain in the shoulder, fatigue, decrease in range of motion, restriction of daily living activities, decrease of muscle strength, postural inbalance,, neuropathy and lymphedema may occur in the acute and chronic period.
Patients with breast cancer need a multidisciplinary and ongoing physiotherapy program.New technologies provide more motivational involvement for patients according to regular care and standard programs. Microsoft Kinect® is a virtual exercise program that is an application. It has been in use for rehabilitation among physical therapists for different deseas.The Kinect® application is a special technological approach that allows to follow the movements of the body. Microsoft Kinect® virtuel reality video games are promissing rehabilitation options because they involve upper extremity practise.
Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to two groups:
Experimental group- where the participants will be treated with standart exercise therapy and Kinect® video-game-based technology
Control Group - Standart exercise therapy and upper extremity rehabilitation-oriented physiotherapy program will be applied.
The evaluations will be repeated at the beginning of the study and at the end of the sixth week. Data obtained from the study will be analyzed using appropriate statistical methods. Patients will be received to therapy which upper extremity rehabilitation or Kinect based video game play under physiotherapist supervision for two days a week for six weeks. Patients will be supported by the home exercise program, except during sessions. Participants' joint range of motion in the initial assessments will be measured by electro-goniometer, muscle strength assessment by JTech hand dynamometer at appropriate evaluation positions and grip force asssessment by Saehan Hydraulic Hand Dynamometer . In assessing pain, pain levels at rest and during activity will be questioned using Visual Analog Scale. Fear of movement of individuals will be assessed via Tampa Kinesiophobia Scale and functional levels will be assessed via Disabilities of the Arm Shoulder and Hand Anketi (DASH). Environmental measurement differences between upper extremities with and without operation will be assessed with made in the arm, forearm and the wrist. In assessing Quality of life will be assessed European Organization for Research and Treatment of Cancer EORTC QLQ-C30 - EORTC- BR23 and finally fatique of individuals will be assessed via Cancer Fatigue Scale -CFS.
Sample size: 17 women for each group. Data Analysis:Data obtained from the study will be analyzed using appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: study groupStandart exercise protocol and KİNECT® video based physiotherapy The treatment protocol of the study group will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises.In total, a 25-minute Kincet® video game program will be applied in addition to the 15-minute basic and standart exercise program. |
| Control group | Active comparator | Other: Control groupStandart exercise protocol and Upper extremity rehabilitation The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients diagnosed with breast cancer and having axillary lymph node dissection,
- Post -operative in two weeks,
- VAS score>1,
- Women who do not present contraindications for physiotherapy (infection, metastasis, locoregional recurrence)
- Women who have read, understood and signed informed consent freely
Key exclusion criteria (5 listed)
- Patients who had breast cancer surgery contralateral or the same side before
- active or metastatic cancer centers
- a neurological condition or orthopedic surgery that affects upper extremity function
- pacemaker, infection, open wound,
- Women with cognitive limitations to understand the information provided, instructions for treatment and consent to their participation in the study.
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 |
|---|---|---|
| study groupAlso: Kinect based therapy and standart exerciseThe treatment protocol will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises. and shoulder proprioception .In addition to the standart exercise therapy, Kincet® video game program will be applied . | Other | Study group |
| Control groupAlso: Standart exercise and upper extremity rehabilitationThe control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol | Other | Control group |
Primary outcome
Range of motion
Time frame: 6 weeks
Shoulder range of motion will be evaluated by digital goniometer. Shoulder flexion degree, shoulder extension degree, abduction and adduction degree, internal rotation and external rotation degree will be assessed with digital goniometer. The results will be recorded in degrees.
5 secondary outcomes
Pain - Visual Analogue Scale-
Time frame: 6 weeks
Muscle strength
Time frame: 6 weeks
Circumference
Time frame: 6 weeks
Grip strength
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Derived from this study: PubMed 31907649Feyzioglu O, Dincer S, Akan A, Algun ZC. Is Xbox 360 Kinect-based virtual reality training as effective as standard physiotherapy in patients undergoing breast cancer surgery? Support Care Cancer. 2020 Sep;28(9):4295-4303. doi: 10.1007/s00520-019-05287-x. Epub 2020 Jan 6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study group in people with Breast Cancer and Upper Extremity Dysfunction, run by Acibadem University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 Nov 2019. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Range of motion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03618433, which also lists 1 linked publication.
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 14 Nov 2019.