THE EFFECT OF VIRTUAL REALITY APPLICATIONS ON SITTING BALANCE IN HEMIPLEGIA: A RANDOMIZED CONTROLLED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Postural Assessment Scale for Stroke
研究概览
简要总结
Objective: The aim of this study was to investigate the effects of virtual reality application on quality of life and functionality, especially sitting balance, in hemiplegic patients.
详细描述
This study was planned as a single-blind randomized controlled prospective study. Patients over 18 years of age with a diagnosis of hemiplegia who applied to Gaziosmanpaşa Training and Research Hospital PTR outpatient clinic and were hospitalized in the rehabilitation service and started a rehabilitation program; will be evaluated with Modified Ashworth, Tardiue Scale, Brunstrom assessment, Stroke Specific Quality of Life Scale, Beck Anxiety Scale, Functional Independence Scale, Mini Mental State Test (MMDT), Mini Mental Test for the Uneducated, Postural Assessment Scale in Stroke Patients, Rivermead Motor Assessment Scale, Sitting Function Test, Berg Balance Scale, System Usability Scale before and after the program.
Patients who apply to the rehabilitation program will be randomly selected by closed envelope method. The first group will receive conventional rehabilitation program and home program. Conventional exercises* of the first group will be performed for 30 sessions of 1 hour every day, in addition to this, the patient will be given a home program.
In the second group, conventional exercises will be performed for 30 sessions of 1 hour every day. In addition to conventional exercises, this group will be enrolled in a balance game group using the Becure Balance System application and the WI balance board for 45 minutes 5 sessions a week.The necessary software and equipment for the virtual reality program were donated by Becure GmbH.
Both groups will be reassessed after 30 sessions. The physician performing the evaluation will be completed blindly by physiotherapists who apply the conventional exercises and the virtual reality program.
The study is a single-center clinical study using prospective data. Between 01.05.2024-01.08.2024, 36 patients are planned to be enrolled in the study.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable medical condition
- •Over 18 years of age
- •A score of 23 or above on the mini mental state test (MMDT) or the mini mental state test for the untrained (MMDT-E)
- •Within the period of 1-18 months after stroke
- •A score of 3 or 4 on the 3rd item of the Berg Balance Scale (BBS), which evaluates the balance of sitting without support (3= can sit for 2 minutes under supervision, 4= can sit safely for 2 minutes).
排除标准
- •Previous history of stroke
- •Aphasic patients in whom information exchange is not possible
- •Patients with impaired vision, hearing and vestibular system
- •Musculoskeletal and nervous system disorders other than stroke that may cause physical disability
- •Patients with a history of epilepsy
- •Cerebrovascular attack involving more than one hemisphere
- •Presence of cerebellar lesions or impaired cerebellar tests
结局指标
主要结局
Postural Assessment Scale for Stroke
时间窗: 1 month
It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture.
Rivermead Motor Assessment Scale
时间窗: 1 month
The Motor Assessment Scale (MAS) is a clinical assessment tool that evaluates eight areas of motor function in recovering stroke patients
Brunnstrom Stages
时间窗: 1 month
The Brunnstrom recovery stages (BRS) is a short and easily administered measure for assessing motor function.
stroke-specific quality of life
时间窗: 1 month
The QOLS was originally a 15-item instrument that measured five conceptual domains of quality of life: material and physical well-being, relationships with other people, social, community and civic activities, personal development and fulfillment, and recreation.
beck anxiety inventory
时间窗: 1 month
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).
mini mental state examination
时间窗: 1 month
The maximum score for the MMSE is 30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.
berg balance scale
时间窗: 1 month
The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance.
modified ashworth scale
时间窗: 1 month
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
The Functional Independence Measure
时间窗: 1 month
The instrument includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
function in sitting test
时间窗: 1 month
The FIST tests balance in seated position. The patient should perform items with their best posture and balance, and while moving in a seated position. The therapist will give them occasional light pushes to test for balance reactions. The therapist will make sure they won't lose their balance.
次要结局
未报告次要终点