Comparison of the Effects of Fully Immersive Virtual Reality in Combination With Treadmill and Bicycle on Functional Capacity in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Gross Motor Function Measure - 88
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Gross Motor Function Measure - 88
时间窗: 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
时间窗: 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)
次要结局
- 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)
研究者
Omer Ayhan
Principal investigator
Istanbul University - Cerrahpasa