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| Name | Class |
|---|---|
| Cairo University | OTHER |
| Prince Sattam Bin Abdulaziz University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional performance assessment | Functional performance was assessed through using the 6-min walk test. | From date of randomization (first week of intervention) |
| Functional performance assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alshimaa Azab, PhD | Prince Sattam Bin Abdulaziz University | Study Director |
| Ragab Elnaggar,, PhD | Prince Sattam Bin Abdulaziz University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University | Al Kharj | Riyadh Region | 11432 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21325859 | Background | 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. | |
| 8863241 | Result |
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The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
6 months after publication
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
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| ID | Term |
|---|---|
| D065630 | Hernias, Diaphragmatic, Congenital |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006548 | Hernia, Diaphragmatic |
| D000082122 | Internal Hernia |
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| 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. |
|
| 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 |
Functional performance was assessed through using the 6-min walk test.
| 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). | 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). | after 12 weeks |
| 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. |
| 33477733 | 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. |
| 37522659 | Derived | Azab 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. |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |