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| Name | Class |
|---|---|
| Ankara City Hospital Bilkent | OTHER |
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The aim of this study is to evaluate the effect of virtual reality applications on the level of independence and upper extremity functionality perceived by children in daily life in children with hemipegic cerebral palsy.
The research is a randomized controlled, cross-over study. The sample group of the research is children diagnosed with hemiplegic cerebral palsy and families who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital.
Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.
The upper extremity functionality of both research groups before the intervention will be evaluated with the 'Motor Activity Diary for Children' scale and the perceived independence level with the 'Children's Hand Use Experience' scale.
After the initial evaluation is completed, group A, represented as the intervention group, will receive ArmeoSenso virtual reality intervention in the upper extremity hand function laboratory for 3 weeks, 5 days a week, each session for 30 minutes, in addition to traditional occupational therapy and physiotherapy rehabilitation programs. Meanwhile, group B, represented as the control group, will continue the traditional occupational therapy and physiotherapy rehabilitation program. At the end of the third week of the intervention, tests measuring upper extremity functionality and perceived independence level will be repeated.
Measurement tools will be repeated at the beginning of the intervention, at the end of the 3rd week, and at the end of the intervention.
The sample group of the research is children between the ages of 6-12, diagnosed with hemiplegic cerebral palsy, who are receiving inpatient treatment in the pediatric service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and their families.
Statistical power analysis was performed to calculate the number of people required to be included in the study. Statistical power analysis was performed with G*Power v.3.1.9.7 software. In the analysis, the Type 1 error margin (α) was accepted as 5% and the desired statistical power (1-β) was accepted as 0.80. In order to carry out the analysis, randomized controlled studies in the literature on the subject that reported effect sizes were examined. Studies have found that in virtual reality-based interventions applied to children with cerebral palsy, strong to very strong effect sizes were reported between intervention and control groups in variables such as upper extremity functions and performance in daily living activities (4, 7-11). When calculations were made using the strong effect size (Cohen's d = 0.80) in the sample size analysis, it was determined that the smallest sample size that needed to be reached for both groups was 26. Therefore, a total of 52 people were included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ArmeoSenso | Other | ArmeoSenso virtual reality application will be applied to group A in the 0-3 weeks of the study and to group B in the 3-6 weeks. |
|
| Traditional rehabilitation | Other | Traditional rehabilitation (physiotherapy and occupational therapy) approaches will continue to be applied to groups A and B at all stages of the research. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArmeoSenso | Other | ArmeoSenso is an upper extremity virtual reality application with three motion sensors and one hand grip sensor. The device detects the person's body, arm, forearm and hand movements and displays the reflection of the movements on the screen. The application includes studies on upper extremity functions. |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP. | The independence levels perceived by children with hemiplegic CP in daily life will be evaluated with the Children's Hand Use Experience Questionnaire. | At the end of the 6th week |
| The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP. | The impact on the upper extremity functionality of children with hemiplegic CP in daily life will be evaluated with the Pediatric Motor Activity Log-Revised test. | At the end of the 6th week |
| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry of virtual reality applications | As suggested in further research, examining the dosimetric properties of virtual reality applications such as frequency and duration and comparing them with other studies. | At the end of the 6th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Başak Karadağ, MSc. | Contact | +905059462128 | karadagbasak@outlook.com | |
| Meral Huri, Professor | Contact | +905335515590 | mrlhuri@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Başak Karadağ, MSc | Ankara City Hospital Bilkent | Principal Investigator |
| Meral Huri, Professor | Hacettepe University | Study Director |
| Berke Aras, Ass.Prof. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Multiple Locations | Ankara | 06000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24819682 | Background | Chen YP, Lee SY, Howard AM. Effect of virtual reality on upper extremity function in children with cerebral palsy: a meta-analysis. Pediatr Phys Ther. 2014 Fall;26(3):289-300. doi: 10.1097/PEP.0000000000000046. | |
| 35237486 | Background | Goyal C, Vardhan V, Naqvi W. Virtual Reality-Based Intervention for Enhancing Upper Extremity Function in Children With Hemiplegic Cerebral Palsy: A Literature Review. Cureus. 2022 Jan 28;14(1):e21693. doi: 10.7759/cureus.21693. eCollection 2022 Jan. |
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Only the principal investigator can access information about individuals; other researchers will not be able to access this information due to blinding.
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Two groups, intervention (A) and control (B), will be created from the target research group using the randomization method.
Intervention group (A) will receive virtual reality application for 30 minutes, 5 days a week for 3 weeks, in addition to traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and will receive only traditional treatments between 3-6 weeks.
The control group (B) will receive only traditional occupational therapy and physiotherapy approaches for the first 3 weeks, and between 3-6 weeks, they will receive virtual reality application in addition to traditional approaches for 30 minutes, 5 days a week for 3 weeks.
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| Traditional Rehabilitation | Other | It includes traditional occupational therapy and physiotherapy approaches. |
|
| Ankara City Hospital Bilkent |
| Principal Investigator |
| Özge Tezen, MD | Ankara City Hospital Bilkent | Study Chair |