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

Bahçeşehir University

Status: Enrolling

Conditions: Lower Urinary Tract Dysfunction

Treatments: Behavioral: Urotherapy training; Other: Video Game-Based Balance Exercise Training; Other: Diaphragmatic Breathing Exercise; Other: Functional Exercise Training; Other: Biofeedback-Assisted Pelvic Floor Muscle Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07126977

-78097791-020-4281

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Other: Biofeedback-Assisted Pelvic Floor Muscle Exercises

Other: Functional Exercise Training

Other: Diaphragmatic Breathing Exercise

Other: Video Game-Based Balance Exercise Training

Behavioral: Urotherapy training

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Biofeedback-Assisted Pelvic Floor Muscle Exercises

Other: Functional Exercise Training

Other: Diaphragmatic Breathing Exercise

Behavioral: Urotherapy training