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Completed

NCT Number: NCT05612503

Virtual Reality and Congenital Diaphragmatic Hernia

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.

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Key information

Conditions

Virtual Reality Children Congenital Abnormalities Congenital Diaphragmatic Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, 11432, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional physical therapy program

Other

resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.

Virtual reality-based exercises

Other

Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.

Primary outcomes

  1. Pulmonary function test, forced expiratory volume in the first second

    Time frame: From date of randomization (first week of intervention)

    A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).

  2. Pulmonary function test, forced expiratory volume in the first second

    Time frame: after 12 weeks

    A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).

  3. Pulmonary function test, forced vital capacity

    Time frame: From date of randomization (first week of intervention)

    A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).

  4. Pulmonary function test, forced vital capacity

    Time frame: after 12 weeks

    A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).

  5. Pulmonary function test, FEV1/FVC ratio

    Time frame: From date of randomization (first week of intervention)

    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.

  6. Pulmonary function test, FEV1/FVC ratio

    Time frame: after 12 weeks

    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.

  7. Exercise capacity assessment

    Time frame: From date of randomization (first week of intervention)

    Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.

  8. Exercise capacity assessment

    Time frame: after 12 weeks

    Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.

Secondary outcomes

  1. Functional performance assessment

    Time frame: From date of randomization (first week of intervention)

    Functional performance was assessed through using the 6-min walk test.

  2. Functional performance assessment

    Time frame: after 12 weeks

    Functional performance was assessed through using the 6-min walk test.

  3. Pediatric Quality of Life Inventory

    Time frame: From date of randomization (first week of intervention)

    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).

  4. Pediatric Quality of Life Inventory

    Time frame: after 12 weeks

    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).

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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