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IRCT20220814055691N1 IRCT 2022-10-09 Iran University of Medical Sciences tele biofeedback and shoulder physiotherapy effectiveness on the quality of life of breast cancer patients with a history of mastectomy Comparison of the therapeutic effectiveness of telebiofeedback and conventional shoulder physiotherapy methods on improving the quality of life of breast cancer patients with a history of mastectomy 2022-09-05 anticipated 60 Complete https://irct.ir/trial/65277 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be simple, which is done by the random numbers table method The table of random numbers is a set of numbers without a specific pattern and order, which is determined to read the numbers first, and in this study, even numbers will be telebiofeedback and odd numbers will be physiotherapy. Due to the fact that the sampling is done in a multi-centered manner, the method of concealment is done centrally, and the participants' entry into the study is done by phone call to the Firuzgar center, Blinding description: Patients were evaluated by a separate researcher who did not participate in the selection and treatment of patients and was blind to the procedure. N/A breast cancer. Intervention 1: Intervention group: In the intervention group (telebiofeedback) which is a specific type of physiotherapy for the shoulder joint and muscles in which the surface electrodes are placed on the patient's skin in specific areas and record the electrical activity of certain muscles based on the location. Patients are first trained on how to use the device, These people will be given the necessary explanations on how to communicate with the doctor/therapist. For 2 months, 2 sessions per week in the first month and 1 session per week in the second month and each session for 20 minutes underwent shoulder muscle biofeedback therapy to strengthen weakened muscles And the necessary muscle relaxation is based on the initial assessment and established protocols. In these sessions, the doctor/therapist is present online And according to the access to the biofeedback program and the results obtained from it, it controls and reviews the sports. During the sessions, the therapist determines the intensity and frequency of the exercises that the patient should do according to the progress of the patient and the frequent evaluations he performs before, during and after the session. Intervention 2: Control group: In the control group, patients are subjected to conventional shoulder physiotherapy for 2 months, 2 sessions per week in the first month and one session per week in the second month, and each session lasts 20 minutes, based on the mentioned protocols. In the control group, the same patients for 2 months, 2 sessions per week in the first month and one session per week in the second month and each session for 20 minutes under conventional shoulder physiotherapy which includes electrical stimulation methods, infrared rays and ultrasound and training Sports will be included. In both cases, due to the nature of sports, the patient will not be deprived of the minimum necessary measures and will not cause a disturbance in the patient's recovery process. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No additional information
public Mozhde mogammadpour
behafrin ave. valiasr squer firozgar hospital
tehran Iran (Islamic Republic of) 1593748712 +98 21 8214 1229 mozhde.mohammadpour73@gmail.com Iran University of Medical Sciences scientific bijan forough
behafrin ave.valiasr square firozgar hospital
tehran Iran (Islamic Republic of) 1593748711 +98 21 8214 1229 bforough@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women over 18 and under 65 years old with breast cancer who have undergone radical mastectomy modification. 18 years 65 years Female metastatic cancer pregnancy history of trauma to neck and upper limb cognition impairment radiation leaving Tehran Death reluctance to intervention any previous dysfunction in shoulder function D05 Carcinoma in situ of breast Rehabilitation Rehabilitation Intervention group: In the intervention group (telebiofeedback) which is a specific type of physiotherapy for the shoulder joint and muscles in which the surface electrodes are placed on the patient's skin in specific areas and record the electrical activity of certain muscles based on the location. Patients are first trained on how to use the device, These people will be given the necessary explanations on how to communicate with the doctor/therapist. For 2 months, 2 sessions per week in the first month and 1 session per week in the second month and each session for 20 minutes underwent shoulder muscle biofeedback therapy to strengthen weakened muscles And the necessary muscle relaxation is based on the initial assessment and established protocols. In these sessions, the doctor/therapist is present online And according to the access to the biofeedback program and the results obtained from it, it controls and reviews the sports. During the sessions, the therapist determines the intensity and frequency of the exercises that the patient should do according to the progress of the patient and the frequent evaluations he performs before, during and after the session. Control group: In the control group, patients are subjected to conventional shoulder physiotherapy for 2 months, 2 sessions per week in the first month and one session per week in the second month, and each session lasts 20 minutes, based on the mentioned protocols. In the control group, the same patients for 2 months, 2 sessions per week in the first month and one session per week in the second month and each session for 20 minutes under conventional shoulder physiotherapy which includes electrical stimulation methods, infrared rays and ultrasound and training Sports will be included. In both cases, due to the nature of sports, the patient will not be deprived of the minimum necessary measures and will not cause a disturbance in the patient's recovery process. Quality of life in qlqc30 questionnaire. Timepoint: The intervention is measured in weeks 0, 4, and 12 after intervention. Method of measurement: Based on Quality of Life Questionnaire-Core 30 (QLQC30) questionnaire. Iran University of Medical Sciences Approved 2022-06-19 Research Ethics Committee of Iran University of Medical Sciences. Valiasr Square, Beh Afarin Street, Firouzgar Hospital. tehran Tehran Iran (Islamic Republic of)