The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients
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
- Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)
研究概览
简要总结
The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures (dolphin, orca, axolotl). Video games lead to high levels of motivation and arousal, provide immediate feedback and playback, provide explicit reward and implicit success, and titrate difficulty levels. This encourages the practice of exercise, being an important complement to physiotherapy sessions.
The main goal of this study is to evaluate the feasibility, safety and efficacy of an immersive virtual reality software (Dolphin, 2.0) in Parkinson's disease symptomatic control, in a two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
single-blind (blind rater for primary and secondary outcomes)
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;
- •Willing and able to provide written informed consent to participate in the study.
排除标准
- •History of falls (1 fall in the 3 previous months);
- •Psychiatric major co-morbidity (e.g., major depressive disorder as determined by DSM IV criteria);
- •A Montreal Cognitive Assessment (MoCA) score < 21;
- •Significant visual or visual-perceptual deficits or neuropsychological impairments that may limit participation in the protocol;
- •Having any other neurological/orthopaedic disorders likely to affect gait or exercise capacity, e.g., history of stroke;
- •Unstable medical condition including cardiovascular instability in the past 6 months
- •Interfering activities performed at high level (sports);
- •Inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.
研究组 & 干预措施
Active arm
The active arm will include 3 days a week of training with the Dolphin 2.0 for 12 consecutive weeks. Each session will have the duration of 60 minutes.
干预措施: Dolphin 2.0 (Device)
Delayed-start control arm
The delayed-start control arm will have six-weeks of physiotherapy specialized for PD (3 times/week, 60 minutes/session) and six-weeks of 3 days a week of training with the Dolphin 2.0, with sessions of 60 minutes.
干预措施: Dolphin 2.0 (Device)
结局指标
主要结局
Time reduction in seconds in the Time Up and Go (TUG) test (early intervention effect)
时间窗: 6-weeks (T1)
Early intervention effect: superiority of active versus control group with respect to TUG at 6 weeks
次要结局
- Time reduction in seconds in the TUG test (late intervention effect)(12-weeks (T2) and 16-weeks (T3))
- Number of steps/day(Baseline, 6-week, 12-week and 16-week)
- Time spent in each level of activity(Baseline, 6-week, 12-week and 16-week)
- Change in Schwab and England scale(at baseline and 12-week)
- Patients' satisfaction and perceived exertion(after the 1st session of 1st week and the last sessions of 6th and 12th weeks)
- Change in MDS-UPDRS(Baseline, 6-week, 12-week and 16-week)
- System Usability Scale(after the 1st session of 1st week and the last sessions of 6th and 12th weeks)
- Change in BMI(Baseline, 6-week, 12-week and 16-week)
- Change in PDQ-39 score(at baseline and and 12-week)
- Change in Patient Global Impression - Change(Baseline, 6-week, 12-week and 16-week)
- Simulator Sickness Questionnaire(after the 1st session of 1st week and the last sessions of 6th and 12th weeks)
- Change in Mini-best test(Baseline, 6-week, 12-week and 16-week)
- Change in SCOPA-Cog(at baseline and 16-week)
- Change in Clinical Global Improvement(Baseline, 6-week, 12-week and 16-week)