Virtual Reality and Congenital Diaphragmatic Hernia

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

Study Overview

• Status: Completed
• Conditions: Children; Congenital Diaphragmatic Hernia; Virtual Reality
• Intervention / Treatment: Other: Traditional physical therapy program; Other: Virtual reality-based exercises

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al-Kharj, Riyadh, Saudi Arabia, 11432
      • Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qassim University
• Collaborators: Cairo University; Prince Sattam Bin Abdulaziz University
• Investigators: Study Director: Alshimaa Azab, PhD, Prince Sattam Bin Abdulaziz University; Study Chair: Ragab Elnaggar,, PhD, Prince Sattam Bin Abdulaziz University

Publications and helpful links

General Publications

• van den Hout L, Schaible T, Cohen-Overbeek TE, Hop W, Siemer J, van de Ven K, Wessel L, Tibboel D, Reiss I. Actual outcome in infants with congenital diaphragmatic hernia: the role of a standardized postnatal treatment protocol. Fetal Diagn Ther. 2011;29(1):55-63. doi: 10.1159/000322694. Epub 2011 Feb 3.
• Zaccara A, Turchetta A, Calzolari A, Iacobelli B, Nahom A, Lucchetti MC, Bagolan P, Rivosecchi M, Coran AG. Maximal oxygen consumption and stress performance in children operated on for congenital diaphragmatic hernia. J Pediatr Surg. 1996 Aug;31(8):1092-4; discussion 1095. doi: 10.1016/s0022-3468(96)90094-9.
• Rutkowski S, Szczegielniak J, Szczepanska-Gieracha J. Evaluation of the Efficacy of Immersive Virtual Reality Therapy as a Method Supporting Pulmonary Rehabilitation: A Randomized Controlled Trial. J Clin Med. 2021 Jan 18;10(2):352. doi: 10.3390/jcm10020352.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2021
• Primary Completion (Actual): September 9, 2021
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: RHPT/2021/0074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No