[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602704":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":46,"centralContacts":55,"locations":63,"responsibleParty":79,"collaborators":29,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":29,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":29,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":66,"whyStopped":29,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Bahçeşehir University","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Virtual reality-assisted, video game-based balance exercises will be implemented in addition to the standard protocol for pelvic floor muscle rehabilitation. The exercise sessions will consist of a 5-minute warm-up period, 20 minutes of balance exercises, and a 5-minute cool-down period. All sessions will follow the same protocol, with the same game sequence and durations. Each game will be played for approximately 5 minutes. However, the number of repetitions for each game will vary depending on the participant's performance level.\n\nAs a therapeutic tool, the Wii console, Wii Fit Plus game disc, and Wii Balance Board will be used. The selected exercise games will include Hula Hoop Plus, Penguin Slide, Soccer Heading, Table Tilt, Tightrope Walk, Ski Jump, and Step Up.",[13,14,15,16,17],"Behavioral: Urotherapy training","Other: Diaphragmatic Breathing Exercise","Other: Biofeedback-Assisted Pelvic Floor Muscle Exercises","Other: Video Game-Based Balance Exercise Training","Other: Functional Exercise Training",{"label":19,"type":20,"description":21,"interventionNames":22},"Control group","ACTIVE_COMPARATOR","The pelvic floor rehabilitation program consists of urotherapy education, diaphragmatic breathing exercises, biofeedback-assisted pelvic floor muscle exercises, and functional exercises. All children and their parents participating in the study will receive urotherapy education prior to the PFMR interventions. The urotherapy session will last approximately 60 minutes. Diaphragmatic breathing exercises will be performed in 3 sets of 10 repetitions. No invasive procedures will be used during the biofeedback-assisted pelvic floor exercises. Exercises will begin lying down and progress as control improves. These exercises will be performed for a total of 20 minutes, consisting of 2-5 seconds of contraction followed by 5-10 seconds of relaxation. The program will also include exercises aimed at improving core stabilization, dynamic neuromuscular control, and pelvic mobility. Exercise selection, repetitions, and duration will be adjusted based on individual needs and progression.",[13,14,15,17],[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Urotherapy training","Standard urotherapy consists of five main components aimed at regulating lower urinary tract (LUT) function in children: education about LUT function and dysfunction, establishing healthy voiding habits and behavioral modifications, lifestyle recommendations such as balanced fluid intake and nutrition, monitoring of symptoms and voiding habits, and consistent caregiver support. In contrast, specific urotherapy focuses on treating particular LUT dysfunctions and includes interventions such as alarm therapy, pelvic floor training, biofeedback, neuromodulation, and clean intermittent catheterization. All children and their caregivers participating in our study will receive urotherapy training prior to the pelvic floor rehabilitation interventions. Each urotherapy session will last approximately 60 minutes.",[19,9],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Diaphragmatic Breathing Exercise","The exercise will be performed under the supervision of a physiotherapist, twice a week for 8 weeks. After the correct position is established, participants will be instructed to slowly inhale through their nose and focus on feeling the breath move from top to bottom (cranial to caudal). They will be asked to hold their breath for a few seconds, then exhale slowly through pursed lips. Additionally, they will be reminded not to push only their abdomen upward while inhaling, but to feel the intra-abdominal pressure expanding evenly in all directions (360 degrees). This exercise will be performed in 3 sets of 10 repetitions.",[19,9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Biofeedback-Assisted Pelvic Floor Muscle Exercises","No invasive procedures will be performed. The physiotherapist will begin with external palpation of the perineal area to teach correct pelvic floor contractions without using accessory muscles. Once the patient masters this, animation-supported biofeedback exercises will start. If relaxation is insufficient, biofeedback will first target muscle relaxation.\n\nUsing the NeuroTrac Myoplus Pro4 device, surface electrodes will be placed at 2 and 7 o'clock on the perineum, and the reference electrode on the right thigh. Exercises will start in a lying position and progress to sitting and standing as control improves. Each session will last about 20 min, with 2-5 s contractions followed by 5-10 s relaxations.",[19,9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Video Game-Based Balance Exercise Training","In our study, in addition to the standard protocol, virtual reality-supported video game-based balance exercises will be performed twice a week for 8 weeks. Each session will include a 5-minute warm-up, 20 minutes of balance exercises, and a 5-minute cool-down period. All sessions will follow the same protocol, with identical game order and duration. Each game will be played for approximately 5 minutes, and the number of repetitions for each game will vary depending on the participant's performance level.\n\nAs a therapeutic tool, the Wii console, Wii Fit Plus game disc, and Wii Balance Board will be used. The selected exercise games will include Hula Hoop Plus, Penguin Slide, Soccer Heading, Table Tilt, Tightrope Walk, Ski Jump, and Step Up.",[9],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Functional Exercise Training","Our study will include exercises aimed at improving core stabilization, dynamic neuromuscular control, and pelvic mobility. Exercise selection will be tailored to individual needs, and the number of repetitions and duration will be adjusted based on the participant's progress. Preferred exercises will include movements such as bridge, dead bug, bilateral arm and leg lift, bear position, cat-camel, and pelvic clock.",[19,9],[47,51],{"name":48,"affiliation":49,"role":50},"Tuğçe Oskay, BSc, PT","Bahçeşehir Univ, Grad Sch of Health Sci, MSc Physiotherapy & Rehabilitation, Istanbul, Turkey","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":53,"role":54},"Tuğçe Tahmaz, PT, PhD","Bahçeşehir Univ, Faculty of Health Sci, Physiotherapy & Rehabilitation Dept, Istanbul, Turkey","STUDY_DIRECTOR",[56,60],{"name":48,"role":57,"phone":58,"phoneExt":29,"email":59},"CONTACT","+90 5419079413","tugce.oskay@bahcesehir.edu.tr",{"name":52,"role":57,"phone":61,"phoneExt":29,"email":62},"+90 5330397791","tugce.tahmaz@bau.edu.tr",[64],{"facility":65,"status":66,"city":67,"state":29,"zip":29,"country":68,"countryCode":29,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Tuğtepe Pediatric Urology and Surgery Clinic","RECRUITING","Istanbul","Turkey (Türkiye)",{"type":70,"coordinates":71},"Point",[72,73],28.94966,41.01384,{"lat":73,"lon":72},[76,78],{"name":48,"role":57,"phone":77,"phoneExt":29,"email":59},"+905419079413",{"name":48,"role":50,"phone":29,"phoneExt":29,"email":29},{"type":50,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Tuğçe Oskay","Physiotherapist","100602704","video-game-based-balance-training-in-children-with-lower-urinary-tract-dysfunction-100602704",false,"NCT07126977","Video Game-Based Balance Training in Children With Lower Urinary Tract Dysfunction","The Effect of Video Game-Based Balance Exercises Added to Standard Rehabilitation on Clinical Symptoms and Pelvic Floor Muscle Functions in Children With Lower Urinary Tract Dysfunction","Inclusion Criteria:\n\n* Being between 5 and 12 years of age\n* Having a diagnosis of \"Lower Urinary Tract Dysfunction\" made by a pediatric urologist according to the criteria defined by the ICCS\n* Voluntary participation of both the parent and the child in the study\n\nExclusion Criteria:\n\n* Having any neurologically based condition\n* Presence of any condition in the parent or child that affects the ability to respond to the assessment tools (e.g., intellectual disability, developmental delay, cognitive problems)\n* Having any physical impairment (orthopedic, structural, etc.) that prevents the use of Wii-Fit\n* Presence of malformations or anatomical anomalies in the urinary tract system\n* History of urological surgery\n* Having constipation and\u002For fecal incontinence\n* Previous participation in pelvic floor muscle rehabilitation\n* Regular use of medication","ALL","5 Years","12 Years",{"count":93,"type":94},30,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study aims to investigate the effects of video game-based balance exercises, in addition to standard treatment, in children aged 5-12 years with lower urinary tract dysfunction (LUTD). The single-center study will include 30 children who will be randomly assigned to an experimental group (video game-based balance exercises + standard treatment) or a control group (standard treatment only). Children in the experimental group will play selected balance games using the Wii console and Wii Balance Board twice a week for 8 weeks.\n\nAll participants will receive the standard program consisting of urotherapy, diaphragmatic breathing exercises, biofeedback-assisted pelvic floor muscle training, and functional exercises. Outcomes will be assessed using a Bladder Diary, uroflowmetry, ultrasonography for post-void residual urine, pelvic floor muscle activity with EMG, the Dysfunctional Voiding and Incontinence Symptoms Score Questionnaire(DVISS), quality of life with the Pediatric Incontinence Quality of Life Questionnaire (PinQ), balance tests, the McGill Core Endurance Test, and the Physical Activity Enjoyment Scale.",[100],"Lower Urinary Tract Dysfunction",[102,103,104],"pelvic floor","lower urinary tract dysfunction","rehabilitation","2025-09-01",{"date":107,"type":108},"2025-09-08","ACTUAL",{"date":110,"type":108},"2025-06-15",{"date":112,"type":94},"2026-02",{"name":5,"class":6},1]