Use of Immersive Virtual Reality and Therapeutic Exercise as Complementary Therapy in Mild to Moderate Parkinson's Disease (InViPark): Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Falls
研究概览
简要总结
This document is intended to provide participant with information about a research study in which the participant is invited to participate. This study was approved by the Research Ethics Committee of ______________________________. If the participant decide to participate, will receive personalized information from the investigator. Please read this document beforehand, and the investigator will ask you any questions you may have to understand the details. If the participant wish, the participant can take this document, review it with others, and take your time to decide whether or not to participate. Participation in this study is completely voluntary and free of charge. The participant can decide not to participate, participate, or change your mind by withdrawing your consent at any time during the project without giving any explanation. The investigators assure the participant that this decision will not affect any future participation with this research group. What is the purpose of the study? To analyze whether the use of a physical exercise program in immersive virtual environments (video games) has greater positive effects on Parkinson's symptoms than traditional rehabilitation programs. Why is the participant being offered to participate? The participant is invited to participate because the participant is a person diagnosed with Parkinson's and because, within the Open Science policies of the University of Vigo, the Galicia Sur Biomedical Foundation, and the Nóvoa Santos Foundation, where bringing research closer to the reality of patients is emphasized, the investigators have selected the specialized Parkinson's center of which the participant is a member to participate in this study.
What does the participation consist of? The participation consists of carrying out 2/3 sessions per week on alternate days of physical exercise, and depending on whether the participant belong to the control or experimental group, the participant will do it regularly or recreated with a video game. The duration of each session will be 15 minutes. Be part of one group or another will depend on chance (like throwing a coin in the air and it comes up Heads or Cross). The total duration of the intervention in both cases is 3 months. During the project, 2 evaluations will be carried out: Initial evaluation and final evaluation. In all of them they will be collected information in relation to their pharmacological treatment linked to the pathology, autonomy functional balance, gait and risk of falls, functional balance, symptoms and disease monitoring and quality of life. Furthermore, in the experimental group the usability and security of the tool will be evaluated immersive virtual reality used. All these assessments will be carried out in your proximity center on the agreed day and time to optimize said process and will have an approximate duration of 30 minutes.
What discomforts or inconveniences does the participation have? The participation requires travel to your reference center to carry out the study. This program, like any physical activity or exercise, may involve greater tiredness and/or musculo-articular discomfort due to the type of exercise to which you will be subjected.
No relevant adverse effects have been recorded in the use of immersive virtual environments (video games).
详细描述
This document is intended to provide participant with information about a research study in which the participant is invited to participate. This study was approved by the Research Ethics Committee of ______________________________. If the participant decide to participate, will receive personalized information from the investigator. Please read this document beforehand, and the investigator will ask you any questions you may have to understand the details. If the participant wish, the participant can take this document, review it with others, and take your time to decide whether or not to participate. Participation in this study is completely voluntary and free of charge. The participant can decide not to participate, participate, or change your mind by withdrawing your consent at any time during the project without giving any explanation. The investigators assure the participant that this decision will not affect any future participation with this research group. What is the purpose of the study? To analyze whether the use of a physical exercise program in immersive virtual environments (video games) has greater positive effects on Parkinson's symptoms than traditional rehabilitation programs. Why is the participant being offered to participate? The participant is invited to participate because the participant is a person diagnosed with Parkinson's and because, within the Open Science policies of the University of Vigo, the Galicia Sur Biomedical Foundation, and the Nóvoa Santos Foundation, where bringing research closer to the reality of patients is emphasized, the investigators have selected the specialized Parkinson's center of which the participant is a member to participate in this study. What does the participation consist of? The participation consists of carrying out 2/3 sessions per week on alternate days of physical exercise, and depending on whether the participant belong to the control or experimental group, the participant will do it regularly or recreated with a video game. The duration of each session will be 15 minutes. Be part of one group or another will depend on chance (like throwing a coin in the air and it comes up Heads or Cross). The total duration of the intervention in both cases is 3 months. During the project, 2 evaluations will be carried out: Initial evaluation and final evaluation. In all of them they will be collected information in relation to their pharmacological treatment linked to the pathology, autonomy functional balance, gait and risk of falls, functional balance, symptoms and disease monitoring and quality of life. Furthermore, in the experimental group the usability and security of the tool will be evaluated immersive virtual reality used. All these assessments will be carried out in your proximity center on the agreed day and time to optimize said process and will have an approximate duration of 30 minutes. What discomforts or inconveniences does the participation have? The participation requires travel to your reference center to carry out the study. This program, like any physical activity or exercise, may involve greater tiredness and/or musculo-articular discomfort due to the type of exercise to which you will be subjected. No relevant adverse effects have been recorded in the use of immersive virtual environments (video games).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from idiopathic PD confirmed by a neurologist.
- •Presenting a stage between 1 and 3 on the Hoehn and Yahr scale.
- •Being able to move around unaided.
- •Absence of dementia with a score on the Mini-Mental State Examination (MMSE) of 18 or higher.
- •Being between 30 and 70 years of age.
排除标准
- •Comorbidity that makes physical exercise inadvisable and that prevents all scheduled assessments from being performed.
- •Severe visual and/or hearing disturbances that impede the session.
- •Having a history of vertigo, seizures, or epileptic seizures.
- •Presence of motor fluctuations and/or dyskinesias, gait blockages, or a history of recent falls.
- •Be receiving stable dopaminergic treatment without changes in the previous 3 months and with a prior plan not to change it during the duration of the study.
- •Be receiving second-line therapy (deep brain stimulation or intraduodenal pump).
- •Be participating in another clinical trial.
- •Not attend at least 80% of the immersive virtual reality sessions.
研究组 & 干预措施
Usual treatment in patient association
Patients participate in memory, relaxation, and occupational therapy workshops.
干预措施: usual treatment patient association (Other)
Exergame and virtual reality program + usual treatment
Weekly sessions (2) of exergame with virtual reality added to the usual treatment
干预措施: exergame program with virtual reality (Other)
Exergame and virtual reality program + usual treatment
Weekly sessions (2) of exergame with virtual reality added to the usual treatment
干预措施: usual treatment patient association (Other)
结局指标
主要结局
Falls
时间窗: From start to end of treatment at 12 weeks
Risk of falling measured with the Tinneti Test
次要结局
- Functional Capacity: lower limbs strength(From start to end of treatment at 12 weeks)
- Functional Capacity: upper limbs strength(From start to end of treatment at 12 weeks)
- Self-perceived quality of life(From start to end of treatment at 12 weeks)
- Mood(From start to end of treatment at 12 weeks)
- Symptoms of the disease(From start to end of treatment at 12 weeks)
- Cognitive ability(From start to end of treatment at 12 weeks)
- Intrinsic aspects of exposure to virtual reality: cyber sickness(From start to end of treatment at 12 weeks)
- Intrinsic aspects of exposure to virtual reality: post game experiences(From start to end of treatment at 12 weeks)
- Cognitive ability(From start to end of treatment at 12 weeks)
- Functional Capacity: balance, gait and risk of falls(From start to end of treatment at 12 weeks)
- Self-perceived quality of life(From start to end of treatment at 12 weeks)
- Functional Capacity: gait function(From start to end of treatment at 12 weeks)
- Functional Capacity: upper limbs strength(From start to end of treatment at 12 weeks)
- Intrinsic aspects of exposure to virtual reality: cyber sickness(From start to end of treatment at 12 weeks)
- Functional Capacity: gait function in dual task(From start to end of treatment at 12 weeks)
- Mood(From start to end of treatment at 12 weeks)
- Functional Capacity: lower limbs strength(From start to end of treatment at 12 weeks)
- Symptoms of the disease(From start to end of treatment at 12 weeks)
- Intrinsic aspects of exposure to virtual reality: post game experiences(From start to end of treatment at 12 weeks)
研究者
Pablo Campo-Prieto
PhD
University of Vigo