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

NCT06317935 | Not Yet Recruiting

• 1 other identifier: HU-ERG-BK-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Virtual Reality; Upper Extremity; Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Dosimetry of virtual reality applications

  At the end of the 6th week

Study Arms (2)

ArmeoSenso

OTHER

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.

Other: ArmeoSenso; Other: Traditional Rehabilitation

Traditional rehabilitation

OTHER

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

Other: Traditional Rehabilitation

Interventions

ArmeoSenso OTHER

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.

ArmeoSenso

Traditional Rehabilitation OTHER

It includes traditional occupational therapy and physiotherapy approaches.

ArmeoSenso; Traditional rehabilitation

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Ankara Bilkent City Hospital

Multiple Locations, Ankara, 06000, Turkey (Türkiye)

Location

Related 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.

  PMID: 24819682 BACKGROUND

• 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.

  PMID: 35237486 BACKGROUND

Study Officials

• Başak Karadağ, MSc

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Meral Huri, Professor

  Hacettepe University

  STUDY DIRECTOR

• Berke Aras, Ass.Prof.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Özge Tezen, MD

  Ankara City Hospital Bilkent

  STUDY CHAIR

Central Study Contacts

Başak Karadağ, MSc.

CONTACT

+905059462128; karadagbasak@outlook.com

Meral Huri, Professor

CONTACT

+905335515590; mrlhuri@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist, PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 19, 2024
• Study Start: April 23, 2024
• Primary Completion: June 29, 2024
• Study Completion: October 29, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)