Effects of Immersive Virtual Reality on Balance of Parkinson's Disease
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Instituto de Investigación Sanitaria Aragón
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Balance-Mini-Balance Systems Test (Mini-BESTest)
概览
简要总结
This study, titled: Effectiveness of immersive virtual reality on balance in people with Parkinson's disease. Is a randomized clinical trial conducted at Zaragoza Parkinson's Association in Spain. It aims to evaluate the effectiveness of a immersive virtual reality program in enhancing balance for patients with Parkinson.s disease (PD). PD is a neurodegenerative disease that has a major impact on patients' balance and gait, affecting their quality of life. Physical rehabilitation is crucial for maintaining and improving balance, and immersive virtual reality promises to be an alternative for improving outcomes in patients with PD.
详细描述
Study Backgroud and Rationale: Parkinson's disease (PD) is one of the most common neurogenerative disease. Parkinson's disease is one of the most common neurodegenerative diseases. Patients suffering from it present a series of motor symptoms, including resting tremors, hyperresistance, bradykinesia, postural instability, and gait disturbances. Postural instability leads to an increase in the number of falls, which leads to greater dependence and social isolation, resulting in a reduced quality of life. Usual physical therapy techniques show an improvement in the motor skills of people with PD; however, their effectiveness is sometimes limited by patient adherence. Objective: The primary objective of this study is to determine whether the Immersive Virtual Reality (IVR) program rehabilitation can improve the balance of people with PD by Mini-Balance Systems Test (Mini-BESTest). Secondary objectives included assessing changes in gait speed, lower limbs strength, functional mobility, quality of life, adherence to the treatment and the possible occurrence of adverse symptoms during the use of IVR. Study Design: This is a single-blind, randomized clinical trial. Fifty patients with PD will be recruited and randomly assigned to either the control group, wich will receive balance conventional physiotherapy rehabilitation thought or the intervention group, wich will receive a IVR program rehabilitation. Both groups will undergo a comprehensive rehabilitation program that will include: active mobility exercises, strength exercises for the main antigravity muscles, and active stretching of the main muscles of the posterior chain. Methodology: There will be eight 40-minute sessions over four weeks. The first 20 minutes will be the same for both groups, while the second part of the session will vary between the control group (standard physical therapy) and the intervention group (IVR).
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
Single Blind (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PD confirmed by a neurologist
- •Age between 55 and 90 years
- •Hoehn \& Yahr Scale score of 1 to 4
- •Cognitive level of 24 or higher on the Mini Mental Examination Test
- •Ability to stand upright without assistance
排除标准
- •Visual or auditory impairments that could interfere with the perception of information or trigger dizziness or epilepsy
- •Musculoskeletal conditions that hinder or prevent the execution of exercises or the ability to maintain a standing position for at least 20 minutes
- •Psychiatric disorders such as moderate or severe depression diagnosed in the last year and impulse control disorders diagnosed in the last year
- •Score of 20 points on the Simulator Sickness Questionnaire (SSQ scale), indicating the presence of severe adverse symptoms
结局指标
主要结局
Balance-Mini-Balance Systems Test (Mini-BESTest)
时间窗: Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).
The primary outcome is the improvement in balnace, which will be evaluated using the Mini-Balance Systems Test (Mini-BESTest). This test assesses static and dynamic balance disorders and determines the risk of falling by evaluating 14 items divided into 4 categories: anticipatory, reactive postural control, sensory orientation and dynamic gait. recovery.static and dynamic balance disorders and determines the risk of falling
次要结局
- Gait speed-10-Meter Walk Test (10MWT)(Gait speed will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).)
- Lower Limb Muscle Strength - 30 seconds Sit to Stand Test (30 CST)(Lower Limb Muscle Strength will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).)
- Functional mobility during walking-Time up and Go (TUG)(Balance will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).)
- Functional mobility performing a dual task-Time Up & Go Dual Task (TUG-DT):(Functional mobility performing a dual task will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).)
- Quality of life- Parkinson Disease Questionnaire-39 (PDQ-39(Quality of life will be assessed at three time points: pre-intervention (M0), the day post-intervention (M1), and 90 days post-intervention (M2).)
- Adverse symptoms- Simulator Sickness Questionnaire (SSQ)(Through intervention completion, an average of 1 month.)
- Adherence to the Immersive Virtual reality program(Through intervention completion, an average of 1 month.)
- Satisfaction with Immersive Virtual Reality Program(Satisfaction with Immersive Virtual Realiity program will be assessed at two time points: the day post-intervention (M1), and 90 days post-intervention (M2).)
研究者
Sandra Calvo Carrión
PhD
Instituto de Investigación Sanitaria Aragón