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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06317935
• Other study ID #: HU-ERG-BK-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 23, 2024
• Est. completion date: October 29, 2024

Study information

• Verified date: March 2024
• Source: Hacettepe University
• Contact: Basak Karadag, MSc.
• Phone: +905059462128
• Email: karadagbasak[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: October 29, 2024
• Est. primary completion date: June 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

Other:
• ArmeoSenso
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.
• Traditional Rehabilitation
It includes traditional occupational therapy and physiotherapy approaches.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Multiple Locations	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Ankara Bilkent City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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