Effect of AR Environment Stimulation on Proactive and Reactive Modulation of Gait in Individuals With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Walking Speed
研究概览
简要总结
Gait disorders in Parkinson's disease (PD), particularly in complex environments or under stress, present challenges for accurate evaluation and classification, such as in cases of freezing of gait. Traditional clinical and laboratory settings often fail to replicate the complexity needed for precise classification, making effective rehabilitation difficult. This study aims to address these challenges by developing an augmented reality (AR)-based environment that mimics real-world stressors and dynamically adapts to the patient's condition. The AR system is designed to facilitate individualized gait training and rehabilitation by modifying environmental difficulty based on real-time feedback from gait performance and stress levels.
Building on Gentile's taxonomy of tasks, the investigators have incorporated PD-specific factors, such as cognitive dual tasks, into our environment classification system. Preliminary results suggest that this system effectively elicits varying gait and heart rate variability (HRV) responses, indicating different stress levels.
This trial will further test the AR environment's ability to classify patients based on their responses to complex, interactive environments, while also investigating the effects of adaptive AR-based gait training on both gait and stress management in individuals with PD.
详细描述
Gait disorder in Parkinson's disease (PD), has been reported to be related to complex environments and stress situations. To perform precise evaluation on gait disorder, such as freezing of gait, is not easy in clinical and/or lab environment, causing the difficulty to make accurate classification of gait disorder. Designing a standard environment stimulation paradigm helps to promote precise classification of gait disorders. Monitoring the stress situation that causes gait disorder, and dynamically modifying environment assists in the facilitation of effective individualized gait rehabilitation for PD patients.
Although Gentile's taxonomy of tasks provides a structure to examine the complexity of movement task in accordance with environmental context, this taxonomy and environmental context does not specifically reflects PD movement problems. In this on-going project, the investigators developed an environment classification system based on Gentile's taxonomy, but added PD related factors, such as cognitive dual task to meet the needs of this population. Our preliminary results showed that this novel classification successfully induced different levels of gait and HRV responses, suggesting different stress situations.
For the following, the investigators plan to apply the Augment reality (AR) technique to produce standard interactive testing and training environment. AR allows us to mimic complex environments in lab for evaluation and rehabilitation. In addition, AR could interactively change the difficulty of environment according to the patients'gait and stress situation which is important for developing effective personal rehabilitation program
The purposes for this project are as follows:
- Test the AR environment stimulation on classifying patients and establish the relationships among challenging AR environment, pressure, and gait
- Investigate the effects of interactive AR gait training on gait and stress for individuals with PD.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson disease.
排除标准
- •Musculoskeletal injuries on legs
- •Osteoporosis.
- •Any peripheral or central nervous system injury or disease patients.
结局指标
主要结局
Walking Speed
时间窗: Baseline, 6 weeks, 8 weeks
The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).
Step Length
时间窗: Baseline, 6 weeks, 8 weeks
The linear distance between the two ankles, typically expressed in centimeter(cm).
Step Time
时间窗: Baseline, 6 weeks, 8 weeks
The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.
Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR)
时间窗: Baseline, 6 weeks, 8 weeks
SDRR is the standard deviation of all recorded RR intervals (the time between successive heartbeats) over a specific period, usually expressed in milliseconds. This measure captures the total variability in heart rate, representing the physiological responses to a variety of internal and external stimuli. High SDRR values generally indicate greater heart rate variability, which is associated with good cardiovascular health and resilience to stress.
Time-Domain Index of HRV：pNN50
时间窗: Baseline, 6 weeks, 8 weeks
Percentage of successive RR intervals that differ by more than 50 ms. pNN50 reflects beat-to-beat variance in heart rate and is considered an indicator of parasympathetic nervous system activity, specifically linked to vagal tone. A higher pNN50 typically indicates better heart rate variability and healthier autonomic function.
Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD)
时间窗: Baseline, 6 weeks, 8 weeks
RMSSD is the square root of the mean of the squares of successive differences between adjacent RR intervals. It emphasizes the high-frequency variations in heart rate that are typically mediated by the parasympathetic nervous system
Frequency-Domain Index of HRV: Low Frequency (LF)
时间窗: Baseline, 6 weeks, 8 weeks
The LF component typically represents the power of the HRV spectrum in the frequency range of 0.04 to 0.15 Hz. It is measured in milliseconds squared (ms²) or normalized units and is often interpreted as reflecting both sympathetic and parasympathetic activity,
Frequency-Domain Index of HRV: High Frequency (HF)
时间窗: Baseline, 6 weeks, 8 weeks
HF typically covers the frequency range from 0.15 to 0.40 Hz and is associated with the respiratory cycle. HF power is usually measured in milliseconds squared (ms²) or normalized units and is indicative of the modulation of heart rate by the parasympathetic nervous system during breathing.
Frequency-Domain Index of HRV: Ratio of LF to HF Power
时间窗: Baseline, 6 weeks, 8 weeks
The ratio of LF (low frequency) to HF power in the HRV spectrum. Since LF can represent both sympathetic and parasympathetic activity, comparing it to HF offers insights into the sympathetic-parasympathetic balance
Total Time to Complete the Time Up and Go test
时间窗: Baseline, 6 weeks, 8 weeks
The time, in seconds, it takes for a participant to complete the TUG test from the initial sitting position to returning to the seated position.
次要结局
- Swing Time(Baseline, 6 weeks, 8 weeks)
- Double Support Time(Baseline, 6 weeks, 8 weeks)
- Single Support Time(Baseline, 6 weeks, 8 weeks)
- Stance Time(Baseline, 6 weeks, 8 weeks)
- Cadence(Baseline, 6 weeks, 8 weeks)
- Total UPDRS-III Score(Baseline, 6 weeks, 8 weeks)
- Total NFOG-Q Score(Baseline, 6 weeks, 8 weeks)
- Non-linear Index of HRV: SD2(Baseline, 6 weeks, 8 weeks)
- Overall PDQ-39 Score(Baseline, 6 weeks, 8 weeks)
- Total HADS Score(Baseline, 6 weeks, 8 weeks)
- Overall PSQI Score(Baseline, 6 weeks, 8 weeks)
- Non-linear Index of HRV: SD1(Baseline, 6 weeks, 8 weeks)
- Non-linear Index of HRV: Ratio of SD1-to-SD2(Baseline, 6 weeks, 8 weeks)
- Total Montreal Cognitive Assessment (MoCA) Score(Baseline, 6 weeks, 8 weeks)
- Total Mini-Mental State Examination (MMSE) Score(Baseline, 6 weeks, 8 weeks)
研究者
Ya-Ju Chang
Professor
Chang Gung University