Clinical trial NCT06428292: Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy
Official title: Comparison of the Effects of Fully Immersive Virtual Reality in Combination With Treadmill and Bicycle on Functional Capacity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Virtual Reality
Function
Balance
Physical Therapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gross Motor Function Measure - 88
timeFrame: 2 times in 8 weeks
measure: 6 Minute Walk Test
timeFrame: 2 times in 8 weeks
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: 2 times in 8 weeks
measure: Timed Up And Down Stairs Test
timeFrame: 2 times in 8 weeks
measure: Timed Up and Go Test
timeFrame: 2 times in 8 weeks
measure: Gross Motor Function Classification System
timeFrame: 2 times in 8 weeks
measure: Pediatric Berg Balance Scale
timeFrame: 2 times in 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul Ünivesitesi - Cerrahpaşa
state: Büyükçekmece
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ipek Yeldan, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.