An interventional study of study group and Control group in Breast Cancer, Upper Extremity Dysfunction and Mastectomy, sponsored by Acibadem University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2019-11-14.
Sponsored by Acibadem University · Not applicable, Interventional, and Treatment
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.
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 34 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Acibadem University is the lead sponsor of 218 studies on the registry; 49 are open to participants now.
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Exclusion Criteria:
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.
Other: study 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
Other: Control 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 .
Also known as: Kinect based therapy and standart exercise
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
Also known as: Standart exercise and upper extremity rehabilitation
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Muscle strength
Hand-held dynamometer will be used to evaluate shoulder muscles' strength
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 6 weeks
Disabilitiy
Disabilities of the Arm Shoulder and Hand ( DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms.The DASH questionnaire consists of three parts.The first part consists of 30 questions. 21 questions assess the difficulty of the patient in daily life activities, 5 question symptoms, and the remaining 4 questions assess social function, work, sleep, and self-confidence of the patient.In the DASH questionnaire, questions are answered in 5-point likert system. 1: no difficulty, 2: mild difficulty, 3: moderate difficulty, 4: extreme difficulty, 5: not at all. The total score varies between 0 and 100 points and the low score indicates good health.
Time frame: 6 weeks
Kinesiophobia
Tampa Kinesiophobia Scale will be used to assess the fear of movement. It is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury. 1 = Absolutely not, 4 = Completely agree.When the total score is between 17 and 68, a higher score means that there is more fear of movement.
Time frame: 6 weeks
Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC QLQ-C30 - EORTC- BR23
The European Organization for Research and Treatment of Cancer EORTC QLQ-C30 (version 3.0) is a cancer-specific measure of life quality. It consists of 30 items to assess physical, role, emotional, cognitive and social functioning, global health status or qualitiy of life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.All scores will linearly transforme to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. More severe symptoms or problems are represented by high symptom scores or items.
Time frame: 6 weeks
Plan to share: No
Ran from Sep 2018 to primary completion in Aug 2019, 10 months.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 10 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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