Video Game-Based Balance Training in Children With Lower Urinary Tract Dysfunction
NCT ID: NCT07126977
Last Updated: 2025-09-08
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-06-15
2026-02-28
Brief Summary
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All 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.
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Detailed Description
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As therapeutic tools, the Wii console, Wii Fit Plus game CD, and Wii Balance Board will be used. Selected exercise games will include Hula Hoop Plus, Penguin Slide, Soccer Heading, Table Tilt, Tightrope Walk, Ski Jump, and Step Up.
In the standard program, participants will receive urotherapy training, diaphragmatic breathing exercises, biofeedback-assisted pelvic floor muscle training, and functional exercise education.
This single-center study will include 30 children aged 5-12 years who have been diagnosed with LUTD. Participants will be randomly assigned to either the experimental group (n=15) or the control group (n=15). No interventional procedures (such as injections or vaccinations) will be performed during the study. Prior to participation, informed consent forms will be obtained from the parents of children who meet the inclusion criteria and voluntarily agree to take part in the study.
Demographic and clinical data of all participants will be collected using a Patient Follow-Up Form prepared by the researchers. To evaluate daily bladder function, parents will be asked to complete a 2-day Bladder Diary under supervision. Voiding function will be assessed by uroflowmetry, while post-void residual urine will be evaluated by a pediatric urologist using ultrasonography. Pelvic floor muscle activity will be measured by a physiotherapist using an EMG-supported device. The severity of LUTD will be determined using the Dysfunctional Voiding and Incontinence Symptoms Score Questionnaire(DVISS). Additionally, the child's quality of life will be evaluated with the Pediatric Urinary Incontinence Quality of Life Questionnaire (PinQ); balance will be assessed with the Pediatric Berg Balance Scale and the Single-Leg Balance Test on a Bosu Ball; core stability with the McGill Core Endurance Test; and enjoyment of the video game-based program with the Physical Activity Enjoyment Scale.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
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.
As 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.
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.
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.
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.
Using 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.
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.
As 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.
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.
Control group
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.
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.
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.
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.
Using 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.
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.
Interventions
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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.
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.
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.
Using 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.
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.
As 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.
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.
Eligibility Criteria
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Inclusion Criteria
* Having a diagnosis of "Lower Urinary Tract Dysfunction" made by a pediatric urologist according to the criteria defined by the ICCS
* Voluntary participation of both the parent and the child in the study
Exclusion Criteria
* 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)
* Having any physical impairment (orthopedic, structural, etc.) that prevents the use of Wii-Fit
* Presence of malformations or anatomical anomalies in the urinary tract system
* History of urological surgery
* Having constipation and/or fecal incontinence
* Previous participation in pelvic floor muscle rehabilitation
* Regular use of medication
5 Years
12 Years
ALL
No
Sponsors
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Bahçeşehir University
OTHER
Responsible Party
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Tuğçe Oskay
Physiotherapist
Principal Investigators
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Tuğçe Oskay, BSc, PT
Role: PRINCIPAL_INVESTIGATOR
Bahçeşehir Univ, Grad Sch of Health Sci, MSc Physiotherapy & Rehabilitation, Istanbul, Turkey
Tuğçe Tahmaz, PT, PhD
Role: STUDY_DIRECTOR
Bahçeşehir Univ, Faculty of Health Sci, Physiotherapy & Rehabilitation Dept, Istanbul, Turkey
Locations
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Tuğtepe Pediatric Urology and Surgery Clinic
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Bright E, Cotterill N, Drake M, Abrams P. Developing a validated urinary diary: phase 1. Neurourol Urodyn. 2012 Jun;31(5):625-33. doi: 10.1002/nau.21254. Epub 2012 Jan 24.
Van Batavia JP, Combs AJ. The Role of Non-invasive Testing in Evaluation and Diagnosis of Pediatric Lower Urinary Tract Dysfunction. Curr Urol Rep. 2018 Apr 6;19(5):34. doi: 10.1007/s11934-018-0784-1.
Zivkovic V, Lazovic M, Vlajkovic M, Slavkovic A, Dimitrijevic L, Stankovic I, Vacic N. Diaphragmatic breathing exercises and pelvic floor retraining in children with dysfunctional voiding. Eur J Phys Rehabil Med. 2012 Sep;48(3):413-21. Epub 2012 Jun 5.
Kilcik MH, Ozdemir F, Elmas AT. Effectiveness of game-based core exercise in children with non-neuropathic bladder dysfunction and comparison to biofeedback therapy. Low Urin Tract Symptoms. 2023 Jan;15(1):16-23. doi: 10.1111/luts.12467. Epub 2022 Nov 11.
Snijders CJ, Vleeming A, Stoeckart R. Transfer of lumbosacral load to iliac bones and legs Part 1: Biomechanics of self-bracing of the sacroiliac joints and its significance for treatment and exercise. Clin Biomech (Bristol). 1993 Nov;8(6):285-94. doi: 10.1016/0268-0033(93)90002-Y.
Duarte Nde A, Grecco LA, Franco RC, Zanon N, Oliveira CS. Correlation between Pediatric Balance Scale and Functional Test in Children with Cerebral Palsy. J Phys Ther Sci. 2014 Jun;26(6):849-53. doi: 10.1589/jpts.26.849. Epub 2014 Jun 30.
Kuru S, Calik BB, Kabul EG, Yigit M. The relationship between the functional status of the extremities and "core" stabilization in women with fibromyalgia. Reumatologia. 2024;62(6):412-420. doi: 10.5114/reum/194594. Epub 2024 Dec 24.
McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
Franjoine MR, Gunther JS, Taylor MJ. Pediatric balance scale: a modified version of the berg balance scale for the school-age child with mild to moderate motor impairment. Pediatr Phys Ther. 2003 Summer;15(2):114-28. doi: 10.1097/01.PEP.0000068117.48023.18.
Erden A, Acar Arslan E, Dundar B, Topbas M, Cavlak U. Reliability and validity of Turkish version of pediatric balance scale. Acta Neurol Belg. 2021 Jun;121(3):669-675. doi: 10.1007/s13760-020-01302-9. Epub 2020 Feb 19.
Tuygun C, Sertcelik N, Bakirtas H, Cakici H, Cetin K, Imamoglu AM. Usefulness of a new dysfunctional voiding and incontinence scoring system in predicting treatment effect in children with voiding dysfunction. Urol Int. 2007;79(1):76-82. doi: 10.1159/000102919.
Akbal C, Genc Y, Burgu B, Ozden E, Tekgul S. Dysfunctional voiding and incontinence scoring system: quantitative evaluation of incontinence symptoms in pediatric population. J Urol. 2005 Mar;173(3):969-73. doi: 10.1097/01.ju.0000152183.91888.f6.
Chmielewska D, Stania M, Kucab-Klich K, Blaszczak E, Kwasna K, Smykla A, Hudziak D, Dolibog P. Electromyographic characteristics of pelvic floor muscles in women with stress urinary incontinence following sEMG-assisted biofeedback training and Pilates exercises. PLoS One. 2019 Dec 2;14(12):e0225647. doi: 10.1371/journal.pone.0225647. eCollection 2019.
Bauer SB, Nijman RJ, Drzewiecki BA, Sillen U, Hoebeke P; International Children's Continence Society Standardization Subcommittee. International Children's Continence Society standardization report on urodynamic studies of the lower urinary tract in children. Neurourol Urodyn. 2015 Sep;34(7):640-7. doi: 10.1002/nau.22783. Epub 2015 May 21.
Samijn B, Van Laecke E, Vande Walle J, Pascal A, Deschepper E, Renson C, Van den Broeck C. Uroflow measurement combined with electromyography testing of the pelvic floor in healthy children. Neurourol Urodyn. 2019 Jan;38(1):231-238. doi: 10.1002/nau.23836. Epub 2018 Oct 12.
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Pekbay Y, Ergin O, Topuz B, Sarikaya S, Acar ZZ, Irkilata HC, Dayanc M. The effects of pelvic floor muscle therapy on symptoms, voiding, and pelvic floor muscle activity parameters in children with overactive bladder. Neurourol Urodyn. 2019 Jun;38(5):1430-1442. doi: 10.1002/nau.24007. Epub 2019 Apr 20.
Toprak N, Sen S, Varhan B. The role of diaphragmatic breathing exercise on urinary incontinence treatment: A pilot study. J Bodyw Mov Ther. 2022 Jan;29:146-153. doi: 10.1016/j.jbmt.2021.10.002. Epub 2021 Oct 20.
Nieuwhof-Leppink AJ, Hussong J, Chase J, Larsson J, Renson C, Hoebeke P, Yang S, von Gontard A. Definitions, indications and practice of urotherapy in children and adolescents: - A standardization document of the International Children's Continence Society (ICCS). J Pediatr Urol. 2021 Apr;17(2):172-181. doi: 10.1016/j.jpurol.2020.11.006. Epub 2020 Nov 5.
Chang SJ, Van Laecke E, Bauer SB, von Gontard A, Bagli D, Bower WF, Renson C, Kawauchi A, Yang SS. Treatment of daytime urinary incontinence: A standardization document from the International Children's Continence Society. Neurourol Urodyn. 2017 Jan;36(1):43-50. doi: 10.1002/nau.22911. Epub 2015 Oct 16.
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Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Walle JV, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: Update report from the standardization committee of the International Children's Continence Society. Neurourol Urodyn. 2016 Apr;35(4):471-81. doi: 10.1002/nau.22751. Epub 2015 Mar 14.
Related Links
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Quality of Life in Children with Urinary Incontinence and Their Families, and the Validity of the PinQ in Turkish Children
Other Identifiers
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-78097791-020-4281
Identifier Type: -
Identifier Source: org_study_id
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