Video Game-Based Balance Training in Children With Lower Urinary Tract Dysfunction

Official title

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

Overview

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. 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.

Detailed description

The aim of this study is to incorporate balance exercises into the standard clinical protocol applied to children with lower urinary tract dysfunction (LUTD) and to implement them through video game-based exercises. This approach is expected to bring about positive changes in clinical symptoms and pelvic floor muscle functions. The video game-based balance exercise program will be conducted in addition to the child's routine treatment, twice a week for a total of 8 weeks at the same rehabilitation center. Each session will consist of a 5-minute warm-up, 20 minutes of balance exercises, and a 5-minute cool-down. All sessions will follow the same protocol, game sequence, and duration. Each game will be played for approximately 5 minutes, and the number of repetitions will vary depending on the participant's performance level.

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.

Interventions

• 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 ala
• Other 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-
• Other 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 o
• Other 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 performa
• Other 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.

Primary outcome measures

• Patient Follow-up Form [Time frame: At the beginning and at the end of the 8th week]
• Uroflowmetry [Time frame: This test will be applied to all participants at the beginning of the study and at the end of the 8th week.]
• Post-Void Residual (PVR) Urine Measurement [Time frame: Measurements will be performed at baseline and at the end of the 8th week for all participating children.]
• Bladder Diary [Time frame: All children participating in our study will be asked to complete a detailed bladder diary with their parents for two consecutive days at baseline and again at the end of the 8th week.]
• EMG - Pelvic Floor Muscle Activation Measurement [Time frame: Measurements of all children participating in the study will be made at the beginning and at the end of the 8th week.]
• Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire [Time frame: We will ask the parents of all children participating in our study to complete this questionnaire at baseline and at the end of the 8th week.]
• Pediatric Incontinence Questionnaire (PinQ) [Time frame: All children participating in our study will be evaluated using this questionnaire at baseline and at the end of the 8th week.]
• Pediatric Berg Balance Scale [Time frame: This scale will be administered by the same physiotherapist to all children in our study at baseline and at the end of the 8th week.]
• Single-Leg Balance Test on Bosu Ball [Time frame: Participants will be evaluated by the same physiotherapist at baseline and at the end of the 8th week.]
• McGill Core Endurance Test [Time frame: Participants will be evaluated by the same physiotherapist at baseline and at the end of the 8th week.]

Eligibility criteria

Inclusion criteria

• Being between 5 and 12 years of age
• 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

• Having any neurologically based condition
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Tuğtepe Pediatric Urology and Surgery Clinic — Istanbul

Publications

• Kuwertz-Broking E, von Gontard A. Clinical management of nocturnal enuresis. Pediatr Nephrol. 2018 Jul;33(7):1145-1154. doi: 10.1007/s00467-017-3778-1. Epub 2017 Aug 21. PMID 28828529
• 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. PMID 22275270
• 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. PMID 29623450
• 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. PMID 22669134
• 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. PMID 36366947
• 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. PMID 23916048
• 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. PMID 25013281
• 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. PMID 39866308

Identifiers

NCT: NCT07126977 · -78097791-020-4281

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗