Breast Cancer Clinical Trial
Official title:
KİNECT® - Video Games Based Physiotherapy Programme in Patients With Breast Cancer Surgery
Verified date | November 2019 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | August 5, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Okemeydani Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 6 weeks | |
Other | 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. | 6 weeks | |
Other | 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. | 6 weeks | |
Primary | 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. | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | Muscle strength | Hand-held dynamometer will be used to evaluate shoulder muscles' strength | 6 weeks | |
Secondary | 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. | 6 weeks | |
Secondary | 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) | 6 weeks | |
Secondary | 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. | 6 weeks |
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