Skip to main content
Clinical Trials/NCT06428292
NCT06428292
Completed
Not Applicable

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

Omer Ayhan1 site in 1 country31 target enrollmentApril 20, 2024
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Omer Ayhan
Enrollment
31
Locations
1
Primary Endpoint
Gross Motor Function Measure - 88
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
July 3, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Omer Ayhan
Responsible Party
Sponsor Investigator
Principal Investigator

Omer Ayhan

Principal investigator

Istanbul University - Cerrahpasa (IUC)

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

Outcomes

Primary Outcomes

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.

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)

Secondary Outcomes

  • 10 Meter Walk Test(2 times in 8 weeks)
  • Gross Motor Function Classification System(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)
  • Pediatric Berg Balance Scale(2 times in 8 weeks)

Study Sites (1)

Loading locations...

Similar Trials