Clinical trial NCT05612503: 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
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Congenital Diaphragmatic Hernia
Children
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Prince Sattam Bin Abdulaziz University
First posted: 2022-11-10
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pulmonary function test, forced expiratory volume in the first second
timeFrame: From date of randomization (first week of intervention)
measure: Pulmonary function test, forced expiratory volume in the first second
timeFrame: after 12 weeks
measure: Pulmonary function test, forced vital capacity
timeFrame: From date of randomization (first week of intervention)
measure: Pulmonary function test, forced vital capacity
timeFrame: after 12 weeks
measure: Pulmonary function test, FEV1/FVC ratio
timeFrame: From date of randomization (first week of intervention)
measure: Pulmonary function test, FEV1/FVC ratio
timeFrame: after 12 weeks
measure: Exercise capacity assessment
timeFrame: From date of randomization (first week of intervention)
measure: Exercise capacity assessment
timeFrame: after 12 weeks
Secondary outcomes:
measure: Functional performance assessment
timeFrame: From date of randomization (first week of intervention)
measure: Functional performance assessment
timeFrame: after 12 weeks
measure: Pediatric Quality of Life Inventory
timeFrame: From date of randomization (first week of intervention)
measure: Pediatric Quality of Life Inventory
timeFrame: after 12 weeks
Other outcomes:
Locations:
city: Al-Kharj
country: Saudi Arabia
facility: Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Alshimaa Azab, PhD
role: STUDY_DIRECTOR
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab Elnaggar,, PhD
role: STUDY_CHAIR
References:
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.
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.
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.