Virtual Reality and Congenital Diaphragmatic Hernia

Study Overview
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Brief Summary
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The study has been designed to investigate the effect of 12 weeks of using virtual reality based exercises on pulmonary functions, exercise capacity, functional performance, and quality of life in children with surgically-repaired congenital diaphragmatic hernia.

Detailed Description
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Children with CDH have significant disruptions in their quality of life (QoL) due to their poor health, in this randomized controlled clinical trial, one important aspect of virtual reality is the interactivity of children and their interests in choosing the exercised game. Each child in two groups perform a specific virtual reality based respiratory exercises for 3 months.

Official Title
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Virtual Reality-based Exercises' Effects on Pulmonary Functions, Cardiopulmonary Capacity, Functional Performance, and Quality of Life in Children With Repaired Congenital Diaphragmatic Hernia

Conditions
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Children, Virtual Reality, Congenital Diaphragmatic Hernia

Intervention / Treatment
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* Other: Traditional physical therapy program
* Other: Virtual reality-based exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 6 and 10 years. BMI was between 20 and 24 kg/m2. surgically-repaired congenital diaphragmatic hernia. respiratory distress symptoms. under follow-up care in pediatric and physical therapy clinic. Exclusion Criteria: Children were excluded if they have growth abnormality. neuromotor disorders. children with cardiac problems. unable to do understand all procedures.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Traditional physical therapy program<br>For 15 minutes, each child in both groups perform the following specific respiratory exercises: resistance-based diaphragm strengthening exercises, breathing exercises. | Other: Traditional physical therapy program<br>* resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.<br>|
| Experimental: Virtual reality-based exercises<br>Following a session of traditional physical therapy, the children in study group toke 30 minutes rest then they joined in a 30-minute VR exercise session using Nintendo Wii systems. | Other: Traditional physical therapy program<br>* resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.<br>Other: Virtual reality-based exercises<br>* Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test, forced expiratory volume in the first second | A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan). | From date of randomization (first week of intervention) | 
| Pulmonary function test, forced expiratory volume in the first second | A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan). | after 12 weeks | 
| Pulmonary function test, forced vital capacity | A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan). | From date of randomization (first week of intervention) | 
| Pulmonary function test, forced vital capacity | A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan). | after 12 weeks | 
| Pulmonary function test, FEV1/FVC ratio | performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded. | From date of randomization (first week of intervention) | 
| Pulmonary function test, FEV1/FVC ratio | performed using a spirometer (Autospiro-507; Minato Medical Science; Osaka. Japan)., (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded. | after 12 weeks | 
| Exercise capacity assessment | Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity. | From date of randomization (first week of intervention) | 
| Exercise capacity assessment | Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity. | after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance assessment | Functional performance was assessed through using the 6-min walk test. | From date of randomization (first week of intervention) | 
| Functional performance assessment | Functional performance was assessed through using the 6-min walk test. | after 12 weeks | 
| Pediatric Quality of Life Inventory | Quality of life was evaluated using self-report Pediatric Quality of Life Inventory (PedsQL), it is multidimensional measures of HRQL in children and adolescents, it includes 23 items distributed among 4 domains [physical (8 items) , emotional( 5 items), social ( 5 items ), and school functions ( 3 items )] including 23 items. It provides child self-report and parents report with 5- points scale ( 0 means never, and 4 means almost always). | From date of randomization (first week of intervention) | 
| Pediatric Quality of Life Inventory | Quality of life was evaluated using self-report Pediatric Quality of Life Inventory (PedsQL), it is multidimensional measures of HRQL in children and adolescents, it includes 23 items distributed among 4 domains [physical (8 items) , emotional( 5 items), social ( 5 items ), and school functions ( 3 items )] including 23 items. It provides child self-report and parents report with 5- points scale ( 0 means never, and 4 means almost always). | after 12 weeks |