Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy

Omer Ayhan

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: Virtual reality device branded ''Meta Quest 2''

Study type: Interventional

Funder types: Other

Identifiers

NCT06428292

IstanbulUC-FTR-OA-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 2 patient groups

combined treadmill with virtual reality

Active Comparator group

Description:

Combining a virtual reality device with a treadmill and using it in a virtual environment, allowing the person to walk in different virtual environments

Treatment:

Device: Virtual reality device branded ''Meta Quest 2''

stationary bike combined with virtual reality

Active Comparator group

Description:

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

Treatment:

Device: Virtual reality device branded ''Meta Quest 2''