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Completed

NCT Number: NCT06428292

Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İstanbul Ünivesitesi - Cerrahpaşa

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality device branded ''Meta Quest 2''

Device

Combining different exercise equipment with a virtual reality device and using them in a virtual environment can be used to decide which one is more effective.

Primary outcomes

  1. Gross Motor Function Measure - 88

    Time frame: 2 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.

  2. 6 Minute Walk Test

    Time frame: 2 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 outcomes

  1. 10 Meter Walk Test

    Time frame: 2 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.

  2. Timed Up And Down Stairs Test

    Time frame: 2 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.

  3. Timed Up and Go Test

    Time frame: 2 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.

  4. Gross Motor Function Classification System

    Time frame: 2 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.

  5. Pediatric Berg Balance Scale

    Time frame: 2 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.

Sponsors and collaborators

Lead sponsor

Omer Ayhan

Other

Registry information

Official study title

Comparison of the Effects of Fully Immersive Virtual Reality in Combination With Treadmill and Bicycle on Functional Capacity in Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 24, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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