Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317935
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-20
Brief Title:
The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP
Sponsor:
Hacettepe University
Organization:
Hacettepe University
Study Overview
Official Title:
The Effect of Virtual Reality Intervention on Upper Extremity Functioning and Perceived Independence in Daily Life in Children With Hemiplegic Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Childrens 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 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 Childrens 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
Detailed Description:
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 GPower v3197 software In the analysis the Type 1 error margin α was accepted as 5 and the desired statistical power 1-β was accepted as 080 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 Cohens d 080 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
Statistical power analysis was performed to calculate the number of people required to be included in the study Statistical power analysis was performed with GPower v3197 software In the analysis the Type 1 error margin α was accepted as 5 and the desired statistical power 1-β was accepted as 080 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 Cohens d 080 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None