Comparison of the Effects of Balance Exercises Performed With Different Visual Stimuli in Individuals With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Timed Up and Go Test
研究概览
简要总结
The study aims to examine the effects of balance exercises applied with different visual stimuli on individuals with MS.
详细描述
The study aims to examine the effects of balance exercises applied with virtual reality glasses, stroboscopic glasses, and visual-based metaphor imaginary on individuals with MS, on their balance functions, coordination skills, and quality of life, and to compare these exercises with both traditional balance exercises, and compare each of them on motor learning, based on their effects on representational areas in the brain, and balance.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages of 18-50
- •diagnosis of MS by a neurologist according to McDonald 2017 criteria (Carroll, 2018)
- •Being between 2.5 and 4.5 on the Expanded Disability Status Scale (EDSS)
- •Not having had an attack in the last 3 months
- •Absence of spasticity severe enough to affect treatment (spasticity in any joint of the upper extremity and lower extremity is <2 according to the Modified Ashworth Scale)
- •Getting ≥ 24 points from the Standardized Mini Mental Test (SMMT)
排除标准
- •hearing or vision problems
- •pregnancy
- •Having changed medication in the last 3 months and using medication containing the active ingredient Fampridine
- •Participating or participating in a regular physiotherapy and rehabilitation program in the last 3 months
- •other accompanying neurological, orthopedic or vestibular disorders
- •an upper or lower extremity contracture that prevents exercises
- •History of epileptic seizure, migraine or vertigo attack in the last 6 months
结局指标
主要结局
Timed Up and Go Test
时间窗: Baseline and end of the 8th week
It is an assessment tool with strong evidence for its validity as a measure of functional mobility in individuals with MS ( Sebastiao et al., 2016 ).
Functional Reach Test
时间窗: Baseline and end of the 8th week
It is an easily applicable dynamic balance measurement technique that has features similar to functional movements. Distances below 15 cm have been found to be associated with an increased risk of falling (Weiner et al., 1992).
Berg Balance Scale
时间窗: Baseline and end of the 8th week
Berg Balance Scale is a scale that is widely used to evaluate balance disorders in multiple sclerosis patients (Berg et al., 1989), provides information about the patient's balance function, and is used to evaluate post-rehabilitation improvements (Gervasoni et al., 2016). The scale consists of 14 items for monitoring performance. Each item is scored between 0 and 4; A high score indicates good balance.
Functional Near Infrared Ray Spectroscopy (fNIRS)
时间窗: Baseline and end of the 8th week
Functional near-infrared spectroscopy is a device used to evaluate brain functions in the cerebral cortex. This device is an optical brain imaging method that measures the blood oxygenation level-dependent (BOLD) response of brain tissues. With this method, relative changes in regional brain oxygenation in the part thought to be associated with brain activation can be determined. In our study, Artinis Brite Lite® fNIRS systems will be used. The system consists of a wearable soft head and has 10 channels. In the evaluation procedure, a trial session will be conducted before the actual measurement, during which the subjects will be fitted with an fNIRS headset. The balance tasks to be evaluated will consist of right and left weight transfer, standing with two feet together, standing on one leg, tandem walking, turning from right to left/left to right, jumping in place and jumping over obstacles (Sathe et al., 2023).
Timed 25 Step Walking Test
时间窗: Baseline and end of the 8th week
It will be used to evaluate the walking speed of individuals. In Z25YT, which evaluates lower extremity function, patients are asked to walk a distance of 7.62 m as quickly as possible, but without running and safely, and the completion time is recorded in seconds.
次要结局
- Quality of Life in Multiple Sclerosis Patients(Baseline and end of the 8th week)
- Fatigue Severity Scale(Baseline and end of the 8th week)
- Lower Extremity Motor Coordination Test(Baseline and end of the 8th week)
研究者
Gülsena Utku
Research Assistant
Halic University