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Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy

Not Applicable
Completed
Conditions
Cerebral Palsy
Interventions
Device: Virtual reality device branded ''Meta Quest 2''
Registration Number
NCT06428292
Lead Sponsor
Omer Ayhan
Brief Summary

This study was conducted in children diagnosed with Cerebral Palsy (CP); It is a prospective randomized clinical study planned to examine the effects of treadmill and bicycle ergometer applications combined with fully immersive virtual reality (TISG) on motor function, balance and walking.

Detailed Description

The aim of this study is in children diagnosed with Cerebral Palsy (CP); It is a comparative study of the effects of treadmill and bicycle ergometer applications combined with total immersive virtual reality (TISG) on motor function, balance and walking. 34 cases diagnosed with Cerebral Palsy between the ages of 12-18 and attending a rehabilitation center will be included in the study. The sample will be divided into two groups by randomization (TİSG combined with treadmill group n = 17, TİSG combined with bicycle ergometer group = 17). Evaluations will be made before and at the end of treatment. An exercise program that will last 45 minutes twice a week for six weeks will be applied to both study groups. The treadmill combined with TİSG group will be given walking training on the treadmill in a virtual environment using virtual reality glasses. The TISG and combined bicycle ergometer group will be given exercise training on the bicycle ergometer in a virtual environment using virtual reality glasses. For both groups, this process will continue in the same order for each exercise in the session. It is assumed that performing the bicycle ergometer in a sitting position makes this exercise safe, easier to perform, and can be performed at different levels of motor function, regardless of the severity of motor impairment. Based on this assumption, this study aimed to compare the use of bicycle ergometer combined with TISG with the treadmill combined with TISG in improving functional capacity, balance and walking functions in children with CP.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
31
Inclusion Criteria
  • Being diagnosed with spastic cerebral palsy
  • Being between the ages of 12 - 18
  • Being at Level 1 and 2 according to the Gross Motor Function Classification System (GMFSS)
  • Being able to understand and speak Turkish
  • Not using medical treatment (including botox) in the last six months
  • No visual or auditory problems that would hinder communication during applications.
  • Having the cognitive skills to adapt to the application and application controls where the intervention is required.
Exclusion Criteria
  • Presence of secondary orthopedic and neurological problems/problems that are severe enough to affect participation in the study (advanced joint instability, severe scoliosis, nystagmus, etc.).
  • Having a neurodegenerative disease that may cause attacks during virtual reality applications
  • Presence of epilepsy
  • Having undergone lower extremity surgery within the last year
  • Presence of hypersensitivity to visual stimuli
  • Development of vestibular problems with the use of virtual reality devices

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
stationary bike combined with virtual realityVirtual reality device branded ''Meta Quest 2''Combining a virtual reality device with a stationary bike and using it in a virtual environment, allowing the person to walk in different virtual environments
combined treadmill with virtual realityVirtual reality device branded ''Meta Quest 2''Combining a virtual reality device with a treadmill and using it in a virtual environment, allowing the person to walk in different virtual environments
Primary Outcome Measures
NameTimeMethod
Gross Motor Function Measure - 882 times in 8 weeks

Gross Motor Function Measure - 88 is a well-known scoring system that evaluates changes in gross motor function. Gross Motor Function Measure - 88 has no age limit and is divided into five gross motor function dimensions: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running and jumping. It consists of 88 items. Each item is scored on a 4-point scale (0-1-2-3). A higher score means better motor function.

6 Minute Walk Test2 times in 8 weeks

6 Minute Walk Test is a standardized, inexpensive and easy-to-implement walking test in which the distance walked in 6 minutes is measured under controlled conditions, the person determines his/her own pace. 6 Minute Walk Test is commonly used to assess functional capacity in children with cerebral palsy (CP)

Secondary Outcome Measures
NameTimeMethod
10 Meter Walk Test2 times in 8 weeks

It is a test used to evaluate the walking speed of individuals. They walk at their normal speed, with or without assistance, on a 14-meter walkway, and the time required for each participant to cover a 10-meter walking distance is measured, starting from 2 marked points 2 m after the starting point and 2 m before the end point.

Gross Motor Function Classification System2 times in 8 weeks

Gross Motor Function Classification System was developed to measure the 'severity of movement disability' in children with cerebral palsy (CP). Gross Motor Function Classification System provides a method to classify the functional abilities of children with CP into one of five levels. As the grade level approaches five, it means that the child's functional ability decreases and he becomes more dependent.

Timed Up And Down Stairs Test2 times in 8 weeks

Timed Up and Down Stair Test attempts to obtain information about the individual's functional mobility by evaluating how long it takes to ascend and descend a 14-step staircase.

Timed Up and Go Test2 times in 8 weeks

Timed Up and Go Test is a valid and reliable test method used to evaluate functional mobility and static and dynamic balance in children with CP. Participants have to stand up from a chair without armrests from the starting position with hips, knees and ankles bent at 90°, walk 3 meters, and return. and they are asked to sit on the chair. Completing the test in less time means more mobility.

Pediatric Berg Balance Scale2 times in 8 weeks

The Pediatric Berg Balance Scale, a modified version of the Berg Balance Scale, is a 14-item, criterion-referenced measurement method that examines functional balance in the context of daily tasks. The 14 items that make up the Pediatric Berg Balance Scale are scored on a 4-point scale. A higher score means better balance.

Trial Locations

Locations (1)

İstanbul Ünivesitesi - Cerrahpaşa

🇹🇷

Istanbul, Büyükçekmece, Turkey

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