Virtual Reality and Congenital Diaphragmatic Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-10

Study Completion Date

2022-04-15

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.

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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.

Conditions

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Virtual Reality Congenital Diaphragmatic Hernia Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Traditional physical therapy program

For 15 minutes, each child in both groups perform the following specific respiratory exercises: resistance-based diaphragm strengthening exercises, breathing exercises.

Group Type SHAM_COMPARATOR

Traditional physical therapy program

Intervention Type 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

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.

Group Type EXPERIMENTAL

Traditional physical therapy program

Intervention Type 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

Intervention Type OTHER

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

Interventions

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Traditional physical therapy program

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

Intervention Type OTHER

Virtual reality-based exercises

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

Intervention Type OTHER

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No