The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP

Hemiplegic Cerebral Palsy Clinical Trial

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

Clinical Trial 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 '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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

• NCT number: NCT06317935
• Study type: Interventional
• Source: Hacettepe University
• Contact: Basak Karadag, MSc.
• Phone: +905059462128
• Email: karadagbasak@outlook.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 23, 2024
• Completion date: October 29, 2024