Children, Congenital Diaphragmatic Hernia, Virtual Reality
Conditions
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.
Interventions
OTHERTraditional physical therapy program
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
OTHERVirtual 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.
Sponsors
Cairo University
Prince Sattam Bin Abdulaziz University
Qassim University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary function test, forced expiratory volume in the first second | 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 | 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, FEV1/FVC ratio | 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. |
| Exercise capacity assessment | From date of randomization (first week of intervention) | Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional performance assessment | From date of randomization (first week of intervention) | Functional performance was assessed through using the 6-min walk test. |
| Pediatric Quality of Life Inventory | From date of randomization (first week of intervention) | 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). |
Countries
Saudi Arabia
Outcome results
None listed