Clinical trial NCT06317935: The Effect of Virtual Reality Application on Independence and Hand Functions in Daily Life in Children With CP
Official title: The Effect of Virtual Reality Intervention on Upper Extremity Functioning and Perceived Independence in Daily Life in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Virtual Reality
Upper Extremity
Hemiplegic Cerebral Palsy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2024-03-19
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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 '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.

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 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.

Eligibility criteria: Inclusion Criteria:

* - Having a diagnosis of hemiplegic SP
* Being between the ages of 6-12
* Not having any fixed contracture in the upper extremity
* According to the Modified Ashworth Scale, the upper extremity spasticity value is at the level of 1,1+,2 or 3
* Being at level I, II or III according to the Gross Motor Function Classification System (GMFCS)
* Being at level II or III according to the Manual Ability Classification System (MACS)
* Being at level I, II or III according to the Communication Function Classification System (CFCS)
* Being within the normal cognitive level according to the Modified Pediatrics Mini Mental Test score
* Being at level I, II or III according to the Eating and Drinking Ability Classification System (EDACS)
* Being at level I, II or III according to the Visual Function Classification System for Children with Cerabral Palsy (VFCS)
* Volunteering to participate in the study

Exclusion Criteria:

* Having botolinum toxin injection within the last 6 months
* Having undergone a surgical procedure within the last 1 year
* Fracture, trauma, etc. in the upper extremity. to live

Primary outcomes:
measure: The effect of virtual reality applications on perceived independence in daily life in hemiplegic CP.
timeFrame: At the end of the 6th week
measure: The effect of virtual reality applications on upper extremity functionality in daily life in children with hemiplegic CP.
timeFrame: At the end of the 6th week
Secondary outcomes:
measure: Dosimetry of virtual reality applications
timeFrame: At the end of the 6th week
Other outcomes:
Locations:
city: Multiple Locations
country: Turkey
facility: Ankara Bilkent City Hospital
state: Ankara
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Başak Karadağ, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Meral Huri, Professor
role: STUDY_DIRECTOR
affiliation: Ankara City Hospital Bilkent
name: Berke Aras, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: Özge Tezen, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.