An interventional study of Traditional physical therapy program and Virtual reality-based exercises in Virtual Reality, Congenital Diaphragmatic Hernia and Children, sponsored by Qassim University. Completed at 1 site in Saudi Arabia. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by Qassim University · Not applicable, Interventional, and Treatment
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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.
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.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
This study's enrollment of 52 is above the median of 30 across 62 interventional studies indexed under Hernias, Diaphragmatic, Congenital.
Browse Hernias, Diaphragmatic, Congenital studies →Qassim University is the lead sponsor of 50 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
Virtual reality exercise using Nintendo Wii systems. As game interfaces, the Nintendo Wii systems employ haptic sensor-based controllers and a balance board.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: after 12 weeks
Exercise capacity assessment
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)
Exercise capacity assessment
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Time frame: after 12 weeks
Functional performance assessment
Functional performance was assessed through using the 6-min walk test.
Time frame: From date of randomization (first week of intervention)
Functional performance assessment
Functional performance was assessed through using the 6-min walk test.
Time frame: 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).
Time frame: 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).
Time frame: after 12 weeks
Plan to share: Yes — The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Supporting information: Study protocol, Informed consent form
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.
Ran from Jan 2021 to primary completion in Sep 2021, 7 months.
Of 40 interventional studies with no phase under Hernias, Diaphragmatic, Congenital, half reached primary completion within 108 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 133. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Hernias, Diaphragmatic, Congenital →
Qassim University