Fully Immersive Virtual Reality Applications in Children With Cerebral Palsy

August 9, 2024 updated by: Omer Ayhan

Comparison of the Effects of Fully Immersive Virtual Reality in Combination With Treadmill and Bicycle on Functional Capacity in Children With Cerebral Palsy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Büyükçekmece
      • Istanbul, Büyükçekmece, Turkey, 34500
        • İstanbul Ünivesitesi - Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Device: 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.
Active Comparator: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure - 88
Time Frame: 2 times in 8 weeks
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
Time Frame: 2 times in 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 Meter Walk Test
Time Frame: 2 times in 8 weeks
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.
2 times in 8 weeks
Timed Up And Down Stairs Test
Time Frame: 2 times in 8 weeks
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.
2 times in 8 weeks
Timed Up and Go Test
Time Frame: 2 times in 8 weeks
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.
2 times in 8 weeks
Gross Motor Function Classification System
Time Frame: 2 times in 8 weeks
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.
2 times in 8 weeks
Pediatric Berg Balance Scale
Time Frame: 2 times in 8 weeks
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.
2 times in 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omer Ayhan

Investigators

  • Study Director: Ipek Yeldan, PhD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Actual)

June 13, 2024

Study Completion (Actual)

July 3, 2024

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 23, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC-FTR-OA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on Virtual reality device branded ''Meta Quest 2''

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe