Clinical trial NCT03618433: KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery
Official title: KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Upper Extremity Dysfunction
Mastectomy
Keywords: kinect
breast cancer
mastectomy
upper extremity dysfunction
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Range of motion
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain - Visual Analogue Scale-
timeFrame: 6 weeks
measure: Muscle strength
timeFrame: 6 weeks
measure: Circumference
timeFrame: 6 weeks
measure: Grip strength
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
Other outcomes:
measure: Disabilitiy
timeFrame: 6 weeks
measure: Kinesiophobia
timeFrame: 6 weeks
measure: Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC QLQ-C30 - EORTC- BR23
timeFrame: 6 weeks
Locations:
city: Istanbul
country: Turkey
facility: Okemeydanı Training and Research Hospital
Study officials:
References:
citation: 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.