Virtual Reality and Congenital Diaphragmatic Hernia

Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612503
• Other study ID #: RHPT/2021/0074
• Status: Completed
• Phase: N/A
• Start date: January 10, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: November 2022
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 15, 2022
• Est. primary completion date: September 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Children
• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital
• Virtual Reality

Intervention

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.
• 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.

Locations

Country	Name	City	State
Saudi Arabia	Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University	Al-Kharj	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Qassim University	Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

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). pii: 352. doi: 10.3390/jcm — View 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. Review. — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	Exercise capacity assessment	Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.	after 12 weeks
Secondary	Functional performance assessment	Functional performance was assessed through using the 6-min walk test.	From date of randomization (first week of intervention)
Secondary	Functional performance assessment	Functional performance was assessed through using the 6-min walk test.	after 12 weeks
Secondary	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)
Secondary	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