KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery

NCT ID: NCT03618433

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-08-05

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.

Conditions

Breast Cancer; Upper Extremity Dysfunction; Mastectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group

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.

Group Type: EXPERIMENTAL

study group

Intervention Type: OTHER

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 group

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

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

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

Interventions

study group

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 .

Intervention Type: OTHER

Control group

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

Intervention Type: OTHER

Other Intervention Names

Kinect based therapy and standart exercise; Standart exercise and upper extremity rehabilitation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Özlem Feyzioğlu

MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Okemeydanı Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 31907649 (View on PubMed)

Other Identifiers

ATADEK-2018 / 9

Identifier Type: -

Identifier Source: org_study_id