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

Hacettepe University

Status: Not yet enrolling

Conditions: Hemiplegic Cerebral Palsy

Treatments: Other: Traditional Rehabilitation; Other: ArmeoSenso

Study type: Interventional

Funder types: Other

Identifiers

NCT06317935

HU-ERG-BK-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 2 patient groups

ArmeoSenso

Other group

Description:

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.

Treatment:

Other: Traditional Rehabilitation

Other: ArmeoSenso

Traditional rehabilitation

Other group

Description:

Traditional rehabilitation (physiotherapy and occupational therapy) approaches will continue to be applied to groups A and B at all stages of the research.

Treatment:

Other: Traditional Rehabilitation