Virtual RealityNCT05612503
Virtual Reality and Congenital Diaphragmatic Hernia
A study testing Traditional physical therapy program and Virtual reality-based exercises in people with Virtual Reality and Congenital Diaphragmatic Hernia, run by Qassim University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Virtual Reality, Congenital Diaphragmatic Hernia, Children
- What is being tested?
- Traditional physical therapy program and Virtual reality-based exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jan 2021to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children were excluded if they have growth abnormality.
- neuromotor disorders.
- children with cardiac problems.
- unable to do understand all procedures.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
Al Kharj, Riyadh Region, 11432
About this study
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
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.
Read the 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.
- Conditions
- Virtual Reality, Congenital Diaphragmatic Hernia, Children
- Being tested
- Traditional physical therapy program, Virtual reality-based exercises
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional physical therapy programOther
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
Virtual reality-based exercisesOther
Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional physical therapy program; Other: Virtual reality-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: after 12 weeks
Exercise capacity assessment
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Measured: 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.
Measured: after 12 weeks
Secondary outcomes (4)
Functional performance assessment
Functional performance was assessed through using the 6-min walk test.
Measured: From date of randomization (first week of intervention)
Functional performance assessment
Functional performance was assessed through using the 6-min walk test.
Measured: 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).
Measured: 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).
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start10 Jan 2021
- Primary completion9 Sep 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Alshimaa Azab, PhD, Study director, Prince Sattam Bin Abdulaziz UniversityRagab Elnaggar,, PhD, Study chair, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612503
- Sponsor's protocol ID
- RHPT/2021/0074
- Status last verified
- Nov 2022
- First submitted
- 27 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
PubMed 21325859Zaccara 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.
PubMed 8863241Rutkowski 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.
PubMed 33477733Azab AR, Elnaggar RK, Abdelbasset WK, Alghadier M, Ahmed AS, Alsharidah AS, Morgan EN, Basha MA, Hassan MA, Kamel FH. Virtual reality-based exercises' effects on pulmonary functions, cardiopulmonary capacity, functional performance, and quality of life in children with repaired congenital diaphragmatic hernia. Eur Rev Med Pharmacol Sci. 2023 Jul;27(14):6480-6488. doi: 10.26355/eurrev_202307_33118.
PubMed 37522659
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05612503
- Acronym / sponsor ID
- RHPT/2021/0074
- Conditions
- Virtual Reality, Congenital Diaphragmatic Hernia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Cairo University, Prince Sattam Bin Abdulaziz University
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy program | Sham comparator | Other: Traditional physical therapy programFor 15 minutes, each child in both groups perform the following specific respiratory exercises: resistance-based diaphragm strengthening exercises, breathing exercises. |
| Virtual reality-based exercises | Experimental | Other: Traditional physical therapy program, Other: Virtual reality-based exercisesFollowing 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Children were excluded if they have growth abnormality.
- neuromotor disorders.
- children with cardiac problems.
- unable to do understand all procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional physical therapy programresistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles. | Other | Traditional physical therapy program, Virtual reality-based exercises |
| Virtual reality-based exercisesVirtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board. | Other | Virtual reality-based exercises |
Primary outcome
Pulmonary function test, forced expiratory volume in the first second
Time frame: From date of randomization (first week of intervention)
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
Time frame: after 12 weeks
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
Time frame: From date of randomization (first week of intervention)
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
Time frame: after 12 weeks
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
Time frame: From date of randomization (first week of intervention)
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
Time frame: after 12 weeks
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
Time frame: From date of randomization (first week of intervention)
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Exercise capacity assessment
Time frame: after 12 weeks
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
4 secondary outcomes
Functional performance assessment
Time frame: From date of randomization (first week of intervention)
Functional performance assessment
Time frame: after 12 weeks
Pediatric Quality of Life Inventory
Time frame: From date of randomization (first week of intervention)
Pediatric Quality of Life Inventory
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Background: PubMed 21325859van 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 publication: PubMed 8863241Zaccara 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 publication: PubMed 33477733Rutkowski 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.
- Derived from this study: PubMed 37522659Azab AR, Elnaggar RK, Abdelbasset WK, Alghadier M, Ahmed AS, Alsharidah AS, Morgan EN, Basha MA, Hassan MA, Kamel FH. Virtual reality-based exercises' effects on pulmonary functions, cardiopulmonary capacity, functional performance, and quality of life in children with repaired congenital diaphragmatic hernia. Eur Rev Med Pharmacol Sci. 2023 Jul;27(14):6480-6488. doi: 10.26355/eurrev_202307_33118.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshimaa Azab, PhD study director
Prince Sattam Bin Abdulaziz University
Ragab Elnaggar,, PhD study chair
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional physical therapy program and Virtual reality-based exercises in people with Virtual Reality and Congenital Diaphragmatic Hernia, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test, forced expiratory volume in the first second (time frame: From date of randomization (first week of intervention)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05612503, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.