Virtual Reality and Congenital Diaphragmatic Hernia

NCT05612503 | Completed

• 1 other identifier: RHPT/2021/0074
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Congenital Diaphragmatic Hernia; Children

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Functional performance assessment

  From date of randomization (first week of intervention)

• Functional performance assessment

  after 12 weeks

• Pediatric Quality of Life Inventory

  From date of randomization (first week of intervention)

• Pediatric Quality of Life Inventory

  after 12 weeks

Study Arms (2)

Traditional physical therapy program

SHAM COMPARATOR

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

Virtual reality-based exercises

EXPERIMENTAL

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; Other: Virtual reality-based exercises

Interventions

Traditional physical therapy program OTHER

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

Traditional physical therapy program; Virtual reality-based exercises

Virtual reality-based exercises OTHER

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

Virtual reality-based exercises

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children were excluded if they have growth abnormality.
• neuromotor disorders.
• children with cardiac problems.
• unable to do understand all procedures.

Sponsors & Collaborators

• Qassim University: lead
• Cairo University: collaborator
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

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

Al Kharj, Riyadh Region, 11432, Saudi Arabia

Location

Related Publications (3)

• 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.

  PMID: 21325859 BACKGROUND

• 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.

  PMID: 8863241 RESULT

• 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.

  PMID: 33477733 RESULT

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alshimaa Azab, PhD

  Prince Sattam Bin Abdulaziz University

  STUDY DIRECTOR

• Ragab Elnaggar,, PhD

  Prince Sattam Bin Abdulaziz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, College of Medical Rehabilitation, Qassim University

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 10, 2022
• Study Start: January 10, 2021
• Primary Completion: September 9, 2021
• Study Completion: April 15, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

SA (1)