Virtual Reality and Congenital Diaphragmatic Hernia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Traditional physical therapy program 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
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
|
| Experimental: Virtual reality-based exercises 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
resistance-based diaphragm strengthening exercises, breathing exercises to increase costal or chest breathing, and breathing exercises to relax the breathing muscles.
Other: Virtual 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.
|
Outcome Measures
Primary Outcome Measures
- 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 expiratory volume in the first second [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 [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 [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 [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 [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 [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 [after 12 weeks]
Cardiopulmonary pulmonary exercise test using the Bruce treadmill test was used to asess the exercise capacity.
Secondary Outcome Measures
- Functional performance assessment [From date of randomization (first week of intervention)]
Functional performance was assessed through using the 6-min walk test.
- Functional performance assessment [after 12 weeks]
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).
- Pediatric Quality of Life Inventory [after 12 weeks]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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age between 6 and 10 years.
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BMI was between 20 and 24 kg/m2.
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surgically-repaired congenital diaphragmatic hernia.
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respiratory distress symptoms.
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under follow-up care in pediatric and physical therapy clinic.
Exclusion Criteria:
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Children were excluded if they have growth abnormality.
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neuromotor disorders.
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children with cardiac problems.
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unable to do understand all procedures.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University | Al-Kharj | Riyadh | Saudi Arabia | 11432 |
Sponsors and Collaborators
- Qassim University
- Cairo University
- Prince Sattam Bin Abdulaziz University
Investigators
- Study Director: Alshimaa Azab, PhD, Prince Sattam Bin Abdulaziz University
- Study Chair: Ragab Elnaggar,, PhD, Prince Sattam Bin Abdulaziz University
Study Documents (Full-Text)
None provided.More Information
Publications
- RHPT/2021/0074