NCT06052930已完成不适用
Immersive Virtual Reality for the Non-pharmacological Management of Parkinson's Disease
Campus Neurológico Sénior1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from baseline to 6-week in TUG cognitive test
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility, safety and efficacy of an immersive virtual reality (IVR) exergaming using a head-mounted display in Parkinson's disease symptomatic control.
This is a parallel-group, single-blinded, randomized controlled trial. The intervention group perform 12 weeks of physiotherapy and IVR, whereas the control group have 6 weeks of physiotherapy only, followed by 6 weeks of physiotherapy and IVR. The primary outcome is the symptomatic effect of the intervention as measured by the change from baseline in Time Up and Go (TUG) test with cognitive dual-task (TUG cognitive).
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)
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
- •Patients diagnosed with Parkinson's disease according to MDS criteria;
- •Hoehn and Yahr stages between I-III (MED ON);
- •Ability to perform the Time Up and Go test in normal pace and without assistance, in less than 11,5 seconds in ON state;
- •Stable medication for the past 1 month;
- •Ability to communicate with the investigator, to understand and comply with the requirements of the study;
- •Able to provide written informed consent to participate in the study.
排除标准
- •Postural instability or freezing of gait in MED ON representing an increased risk of fall, according to the best clinical judgement;
- •A Montreal Cognitive Assessment (MoCA) score < 21;
- •Presence of severe visual loss that could interfere with the ability to see the VR simulation as well as vertigo, epilepsy and psychosis;
- •Unstable medical condition, including cardiovascular, pulmonary or musculoskeletal, that according to the clinician's judgment affect patients' ability to participate in the study;
- •Inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.
结局指标
主要结局
Change from baseline to 6-week in TUG cognitive test
时间窗: 6 week
Change from baseline to 6-week in TUG cognitive test
次要结局
- Change from baseline to each evaluation time point in Parkinson's Disease Questionnaire-39 items (PDQ-39)(6, 12 and 16 weeks)
- Change from baseline to each evaluation time point in BMI(6, 12 and 16 weeks)
- Occurrence of adverse events(16 weeks)
- Change from baseline to each evaluation time point in TUG and TUG with motor and cognitive dual-tasking(6, 12 and 16 weeks)
- Change from baseline to each evaluation time point in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(6, 12 and 16 weeks)
- Change from baseline to each evaluation time point in Schwab and England (S&E) scale(6, 12 and 16 weeks)
- Patients' Borg perceived exertion(16 weeks)
- Likert scale on patients' satisfaction using the virtual reality system(12 weeks)
- Change from baseline to each evaluation time point in Stroop test(6, 12 and 16 weeks)
- Change from baseline to each evaluation time point in Visual Object and Space Perception (VOSP) Battery (cube and fragmented letters)(6, 12 and 16 weeks)
- Change from baseline to each evaluation time point in Clinical and Patient Global Impression of severity(6, 12 and 16 weeks)
- Patients' consideration on system usability using the System Usability Scale (SUS)(1, 6, 12 and 16 weeks)
- Change from baseline to each evaluation time point in Montreal Cognitive Assessment (MoCA)(6, 12 and 16 weeks)
- Occurrence of cybersickness using the Simulator Sickness Questionnaire (SSQ)(16 weeks)
- Change from baseline to each evaluation time point in mini-Balance Evaluation Systems Test (mini-BEST test)(6, 12 and 16 weeks)
研究者
研究点 (1)
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