Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy

NCT ID: NCT06428292

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2024-07-03

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

combined treadmill with virtual reality

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

Group Type: ACTIVE_COMPARATOR

Virtual reality device branded ''Meta Quest 2''

Intervention Type: 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.

stationary bike combined with virtual reality

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

Group Type: ACTIVE_COMPARATOR

Virtual reality device branded ''Meta Quest 2''

Intervention Type: 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.

Interventions

Virtual reality device branded ''Meta Quest 2''

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Omer Ayhan

OTHER

Sponsor Role: lead

Responsible Party

Omer Ayhan

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ipek Yeldan, PhD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

İstanbul Ünivesitesi - Cerrahpaşa

Istanbul, Büyükçekmece, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ochandorena-Acha M, Terradas-Monllor M, Nunes Cabrera TF, Torrabias Rodas M, Grau S. Effectiveness of virtual reality on functional mobility during treadmill training in children with cerebral palsy: a single-blind, two-arm parallel group randomised clinical trial (VirtWalkCP Project). BMJ Open. 2022 Nov 3;12(11):e061988. doi: 10.1136/bmjopen-2022-061988.

Reference Type: BACKGROUND

PMID: 36328390 (View on PubMed)

Cho C, Hwang W, Hwang S, Chung Y. Treadmill Training with Virtual Reality Improves Gait, Balance, and Muscle Strength in Children with Cerebral Palsy. Tohoku J Exp Med. 2016 Mar;238(3):213-8. doi: 10.1620/tjem.238.213.

Reference Type: BACKGROUND

PMID: 26947315 (View on PubMed)

Zeng N, Pope Z, Gao Z. Acute Effect of Virtual Reality Exercise Bike Games on College Students' Physiological and Psychological Outcomes. Cyberpsychol Behav Soc Netw. 2017 Jul;20(7):453-457. doi: 10.1089/cyber.2017.0042.

Reference Type: BACKGROUND

PMID: 28715263 (View on PubMed)

Gagliardi C, Turconi AC, Biffi E, Maghini C, Marelli A, Cesareo A, Diella E, Panzeri D. Immersive Virtual Reality to Improve Walking Abilities in Cerebral Palsy: A Pilot Study. Ann Biomed Eng. 2018 Sep;46(9):1376-1384. doi: 10.1007/s10439-018-2039-1. Epub 2018 Apr 27.

Reference Type: BACKGROUND

PMID: 29704186 (View on PubMed)

Other Identifiers

IstanbulUC-FTR-OA-01

Identifier Type: -

Identifier Source: org_study_id