## Protocol Section
### Identification Module
**NCT ID:** NCT06428292

**Brief Title:** 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

#### Organization Study ID Info
**ID:** IstanbulUC-FTR-OA-01
#### Organization
**Class:** OTHER
**Full Name:** Istanbul University - Cerrahpasa (IUC)
### Status Module
#### Completion Date
**Date:** 2024-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Omer Ayhan

#### Responsible Party

**Investigator Affiliation:** Istanbul University - Cerrahpasa (IUC)

**Investigator Full Name:** Omer Ayhan

**Investigator Title:** Principal investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Cerebral Palsy

**Keywords:**

- Virtual Reality

- Function

- Balance

- Physical Therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** 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.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

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

**Label:** combined treadmill with virtual reality

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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

**Intervention Names:**

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

**Label:** stationary bike combined with virtual reality

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- combined treadmill with virtual reality

- stationary bike combined with virtual reality

**Description:** 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.

**Name:** Virtual reality device branded ''Meta Quest 2''

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Gross Motor Function Measure - 88

**Time Frame:** 2 times in 8 weeks

**Description:** 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)

**Measure:** 6 Minute Walk Test

**Time Frame:** 2 times in 8 weeks

#### Secondary Outcomes

**Description:** 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.

**Measure:** 10 Meter Walk Test

**Time Frame:** 2 times in 8 weeks

**Description:** 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.

**Measure:** Timed Up And Down Stairs Test

**Time Frame:** 2 times in 8 weeks

**Description:** 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.

**Measure:** Timed Up and Go Test

**Time Frame:** 2 times in 8 weeks

**Description:** 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.

**Measure:** Gross Motor Function Classification System

**Time Frame:** 2 times in 8 weeks

**Description:** 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.

**Measure:** Pediatric Berg Balance Scale

**Time Frame:** 2 times in 8 weeks

### Eligibility Module

**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

**Maximum Age:** 18 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** omryhn97@gmail.com

**Name:** Ömer Ayhan, BSc

**Phone:** +905350848014

**Role:** CONTACT

**Contact 2:**

**Email:** aysenurerekdag@gmail.com

**Name:** Ayşenur Erekdağ, MSc

**Phone:** 05548959013

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Istanbul

**Contacts:**

***Contact 1:***

- **Email:** iuc@hs01.kep.tr

- **Name:** Secde N Atamtürk

- **Phone:** +902124040300

- **Phone Ext:** 16601-16602

- **Role:** CONTACT

**Country:** Turkey

**Facility:** İstanbul Ünivesitesi - Cerrahpaşa

**State:** Büyükçekmece

**Status:** RECRUITING

**Zip:** 34500

#### Overall Officials

**Official 1:**

**Affiliation:** Istanbul University - Cerrahpasa (IUC)

**Name:** Ipek Yeldan, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 36328390

**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.

**PMID:** 26947315

**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.

**PMID:** 28715263

**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.

**PMID:** 29704186

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001925

- Term: Brain Damage, Chronic

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5796

- Name: Cerebral Palsy

- Relevance: HIGH

- As Found: Cerebral Palsy

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5202

- Name: Brain Damage, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002547

- Term: Cerebral Palsy

### Misc Info Module

- Version Holder: 2024-05-31
