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Virtual Reality and Congenital Diaphragmatic Hernia

Primary Purpose

Virtual Reality, Congenital Diaphragmatic Hernia, Children

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Traditional physical therapy program
Virtual reality-based exercises
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Virtual Reality

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Traditional physical therapy program

Virtual reality-based exercises

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2022
Last Updated
November 9, 2022
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05612503
Brief Title
Virtual Reality and Congenital Diaphragmatic Hernia
Official Title
Virtual Reality-based Exercises' Effects on Pulmonary Functions, Cardiopulmonary Capacity, Functional Performance, and Quality of Life in Children With Repaired Congenital Diaphragmatic Hernia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Congenital Diaphragmatic Hernia, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional physical therapy program
Arm Type
Sham Comparator
Arm Description
For 15 minutes, each child in both groups perform the following specific respiratory exercises: resistance-based diaphragm strengthening exercises, breathing exercises.
Arm Title
Virtual reality-based exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy program
Intervention Description
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
Intervention Type
Other
Intervention Name(s)
Virtual reality-based exercises
Intervention Description
Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.
Primary Outcome Measure Information:
Title
Pulmonary function test, forced expiratory volume in the first second
Description
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time Frame
From date of randomization (first week of intervention)
Title
Pulmonary function test, forced expiratory volume in the first second
Description
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time Frame
after 12 weeks
Title
Pulmonary function test, forced vital capacity
Description
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time Frame
From date of randomization (first week of intervention)
Title
Pulmonary function test, forced vital capacity
Description
A pulmonary function test was conducted for all participants using a spirometry analyzer (Autospiro-507; Minato Medical Science; Osaka. Japan).
Time Frame
after 12 weeks
Title
Pulmonary function test, FEV1/FVC ratio
Description
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.
Time Frame
From date of randomization (first week of intervention)
Title
Pulmonary function test, FEV1/FVC ratio
Description
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.
Time Frame
after 12 weeks
Title
Exercise capacity assessment
Description
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Time Frame
From date of randomization (first week of intervention)
Title
Exercise capacity assessment
Description
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Functional performance assessment
Description
Functional performance was assessed through using the 6-min walk test.
Time Frame
From date of randomization (first week of intervention)
Title
Functional performance assessment
Description
Functional performance was assessed through using the 6-min walk test.
Time Frame
after 12 weeks
Title
Pediatric Quality of Life Inventory
Description
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).
Time Frame
From date of randomization (first week of intervention)
Title
Pediatric Quality of Life Inventory
Description
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).
Time Frame
after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ragab Elnaggar,, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
City
Al-Kharj
State/Province
Riyadh
ZIP/Postal Code
11432
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
21325859
Citation
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.
Results Reference
background
PubMed Identifier
8863241
Citation
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.
Results Reference
result
PubMed Identifier
33477733
Citation
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.
Results Reference
result

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Virtual Reality and Congenital Diaphragmatic Hernia

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