]>
IRCT20211121053129N1 IRCT 2021-12-01 University of social welfare and rehabilitation sciences The effect of Tele-rehabilitation on stress urinary incontinence Effectiveness of Tele-rehabilitation for supervised pelvic floor motor learning exercise with biofeedback in subjects with stress urinary incontinence (SUI) 2021-12-11 anticipated 40 Complete https://irct.ir/trial/60122 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization. The main idea of block randomization is that patients are divided into m blocks. Each block is randomly chosen in order to put n patients in A group and n patients in B group. This method ensures equal treatment allocation within each block if a complete block is used. We select 10 blocks consisting of 4 patients. An equal number of people are assigned to each group in each block. The block randomization method is designed to randomize the distribution of individuals to the study groups so that the sample size of the groups is equal. This method is used to ensure balance in sample size between groups over time. We will identify 10 blocks with 4 patients in each block, two patients in group A (intervention) and two patients in group B (control), and then randomization will be applied to both blocks in the intervention group and the control group. For example, when a participant enters a study, she is asked to select a block from 1 to 10 and then A or B. When one person selects a block, the order of the other three items is randomly defined. N/A Stress urinary incontinence. Intervention 1: Intervention group: Participants are remotely supervised and operate the biofeedback device themselves. The treatment program will be done in 4 weeks and 14 sessions. 4 sessions will be held in the first and second week and 3 sessions in the third and fourth week each. The protocol consists of: endurance training, strength training, motor-control and motor-learning training. The duration of holding the slow contraction in endurance training will be 6 to 8 seconds and will be done for 3 sets of 10 repetitions. Immediately after the endurance contraction, rest is given for the duration of the contraction. Strength contraction will include 4 rapid contractions. Rapid contraction lasts for 2 seconds at maximum voluntary contraction followed by 2 seconds of rest. In each session, each contraction will be repeated and practiced in the supine, sitting, and standing positions, and after the patient has been able to perform the contractions correctly, these contractions will be coordinated with the movements of the upper and lower limbs. Intervention 2: Control group: The physiotherapist is present next to the patient. The treatment program will be done in 4 weeks and 14 sessions. 4 sessions will be held in the first and second week and 3 sessions in the third and fourth week each. The protocol consists of: endurance training, strength training, motor-control and motor-learning training. The duration of holding the slow contraction in endurance training will be 6 to 8 seconds and will be done for 3 sets of 10 repetitions. Immediately after the endurance contraction, rest is given for the duration of the contraction. Strength contraction will include 4 rapid contractions. Rapid contraction lasts for 2 seconds at maximum voluntary contraction followed by 2 seconds of rest. In each session, each contraction will be repeated and practiced in the supine, sitting, and standing positions, and after the patient has been able to perform the contractions correctly, these contractions will be coordinated with the movements of the upper and lower limbs. Yes - There is a plan to make this available What will be shared: Only part of the individual data of the study participants, such as information about the main outcome or the like, can be shared When: Access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions and also People who are in the industry can apply for them. Conditions: If necessary, the results and data can be provided without mentioning the name. Where to obtain: Contact the researchers to receive the required documents or data. Contact information: E-mail: zah.tajbakhsh@uswr.ac.ir tshzahra@yahoo.com Phone number: 09022073102 address: University of social welfare and rehabilitation sciences, Kudakyar Ave., Daneshju Blvd.,Evin How to obtain: Request from the researchers and obtain permission from the university Comments:
public Zahra Tajbakhsh
No. 43, Shahid jalili Ave., Hengam street, Resalat Square
Tehran Iran (Islamic Republic of) 1677744715 +98 21 7749 6433 zah.tajbakhsh@uswr.ac.ir University of social welfare and rehabilitation sciences scientific Zahra Tajbakhsh
No. 43, Shahid jalili Ave., Hengam street, Resalat Square
Tehran Iran (Islamic Republic of) 1677744715 +98 21 7749 6433 zah.tajbakhsh@uswr.ac.ir University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Women aged between 20 to 50 years Able to use lap-top or computer Diagnosed with stress urinary incontinence only 20 years 50 years Female Pregnancy Delivery within the past six months Immobility Grades 3 or 4 pelvic organ prolapse Diagnosed with any neurologic condition Having received other treatments for stress urinary incontinence N39.3 Stress incontinence (female) (male) Rehabilitation Rehabilitation Intervention group: Participants are remotely supervised and operate the biofeedback device themselves. The treatment program will be done in 4 weeks and 14 sessions. 4 sessions will be held in the first and second week and 3 sessions in the third and fourth week each. The protocol consists of: endurance training, strength training, motor-control and motor-learning training. The duration of holding the slow contraction in endurance training will be 6 to 8 seconds and will be done for 3 sets of 10 repetitions. Immediately after the endurance contraction, rest is given for the duration of the contraction. Strength contraction will include 4 rapid contractions. Rapid contraction lasts for 2 seconds at maximum voluntary contraction followed by 2 seconds of rest. In each session, each contraction will be repeated and practiced in the supine, sitting, and standing positions, and after the patient has been able to perform the contractions correctly, these contractions will be coordinated with the movements of the upper and lower limbs. Control group: The physiotherapist is present next to the patient. The treatment program will be done in 4 weeks and 14 sessions. 4 sessions will be held in the first and second week and 3 sessions in the third and fourth week each. The protocol consists of: endurance training, strength training, motor-control and motor-learning training. The duration of holding the slow contraction in endurance training will be 6 to 8 seconds and will be done for 3 sets of 10 repetitions. Immediately after the endurance contraction, rest is given for the duration of the contraction. Strength contraction will include 4 rapid contractions. Rapid contraction lasts for 2 seconds at maximum voluntary contraction followed by 2 seconds of rest. In each session, each contraction will be repeated and practiced in the supine, sitting, and standing positions, and after the patient has been able to perform the contractions correctly, these contractions will be coordinated with the movements of the upper and lower limbs. International consultation on incontinence questionnaire-short form score. Timepoint: International consultation on incontinence questionnaire-short form score will be field at baseline (before the intervention) and again at the end of the intervention. Method of measurement: International consultation on incontinence questionnaire-short form. Number of urine leakage. Timepoint: Number of urine leakage will be recorded at baseline (before the intervention) and again at the end of the intervention. Method of measurement: Number of urine leakage will be recorded according to the patients' answer to first question in International consultation on incontinence questionnaire-short form. Incontinence-quality of life questionnaire score. Timepoint: Incontinence-quality of life questionnaire score will be field at baseline (before the intervention) and again at the end of the intervention. Method of measurement: Incontinence-quality of life questionnaire. Pelvic floor muscle strength. Timepoint: Pelvic floor muscle strength will be evaluated once before the intervention and again at the end of the intervention. Method of measurement: Perineometer. Pelvic floor muscle endurance. Timepoint: Pelvic floor muscle endurance will be evaluated once before the intervention and again at the end of the intervention. Method of measurement: Perineometer. Pelvic floor muscle neuromuscular coordination. Timepoint: Pelvic floor muscle neuromuscular coordination will be evaluated once before the intervention and again at the end of the intervention. Method of measurement: Perineometer. Patient satisfaction score according to The MedRisk instrument for measuring patient satisfaction with physical therapy care score. Timepoint: The MedRisk instrument for measuring patient satisfaction with physical therapy care score will be field after the intervention. Method of measurement: The MedRisk instrument for measuring patient satisfaction with physical therapy care. University of social welfare and rehabilitation sciences Approved 2021-11-20 Ethics committee of university of social welfare and rehabilitation sciences University of social welfare and rehabilitation sciences, Kudakyar Ave., Daneshju Blvd. Tehran Tehran Iran (Islamic Republic of)