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Clinical Trials/NCT03618433
NCT03618433CompletedNot Applicable

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

Acibadem University1 site in 1 country34 target enrollmentStarted: September 3, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Range of motion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pain - Visual Analogue Scale-(6 weeks)
  • Muscle strength(6 weeks)
  • Circumference(6 weeks)
  • Grip strength(6 weeks)
  • Fatigue(6 weeks)

Investigators

Sponsor
Acibadem University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Özlem Feyzioğlu

MSc

Acibadem University

Study Sites (1)

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