Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy

NCT06428292 | Completed

• 1 other identifier: IstanbulUC-FTR-OA-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Virtual Reality; Function; Balance; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• Gross Motor Function Measure - 88

  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 times in 8 weeks

• 6 Minute Walk Test

  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)

  2 times in 8 weeks

Secondary Outcomes (5)

• 10 Meter Walk Test

  2 times in 8 weeks

• Timed Up And Down Stairs Test

  2 times in 8 weeks

• Timed Up and Go Test

  2 times in 8 weeks

• Gross Motor Function Classification System

  2 times in 8 weeks

• Pediatric Berg Balance Scale

  2 times in 8 weeks

Study Arms (2)

combined treadmill with virtual reality

ACTIVE COMPARATOR

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

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

stationary bike combined with virtual reality

ACTIVE COMPARATOR

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

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

Interventions

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.

combined treadmill with virtual reality; stationary bike combined with virtual reality

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Omer Ayhan: lead

Study Sites (1)

İstanbul Ünivesitesi - Cerrahpaşa

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 36328390 BACKGROUND

• 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.

  PMID: 26947315 BACKGROUND

• 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.

  PMID: 28715263 BACKGROUND

• 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.

  PMID: 29704186 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ipek Yeldan, PhD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator administering the treatment and the investigator performing the evaluations will be different. The evaluator will not know about the interventions that the participants received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: April 20, 2024
• Primary Completion: June 13, 2024
• Study Completion: July 3, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)