Investigate the Effect of AR Environment Stimulation on Gait, Anxiety and Brain Connectivity of Individuals With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Frequency-Domain Index of HRV: High Frequency (HF)
研究概览
简要总结
A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinson's disease (PD) patients through a novel approach involving heart rate variability (HRV) feedback and Augmented Reality (AR) training. The project is based on the premise that improving HRV, which reflects the adaptability of the autonomic nervous system, can enhance both motor functions like gait and non-motor symptoms.
详细描述
Gait impairments are prevalent among individuals diagnosed with Parkinson's disease (PD), presenting as shuffling steps, diminished stride length, increased cadence, freezing of gait, etc. Concurrently, non-motor symptoms, including anxiety, stress, and sleep disturbances, exert a substantial impact on the overall quality of life for PD patients.
Improving heart rate variability (HRV) can positively improve both motor and non-motor symptoms in PD. HRV serves as a reflective measure of the adaptability of the autonomic nervous system, a critical regulator of bodily functions, including gait. Diminished HRV correlates with impaired autonomic function, contributing to the observed gait abnormalities in individuals with Parkinson's disease. Training with HRV feedback has been shown to improve gait performance, stress, and anxiety.
The motor skill taxonomy proposed by Gentile seems to constitute just such a template for rehabilitation programs because it provides a two-dimensional basis for classifying a variety of motor skills. Meanwhile, AR offers a unique platform for creating intricate laboratory environments that facilitate non-invasive evaluation and rehabilitation, enabling the measurement of changes in the autonomic nervous system in response to environmental stimuli. Therefore, an Augmented Reality (AR) training program based on Gentile's theory, incorporating gait and HRV feedback and addressing PD-specific variables, will be developed.
The overarching goal of this 3-year project is to establish an effective environmental stimulation paradigm capable of ameliorating both motor and non-motor symptoms. This paradigm aims to contribute to the creation of tailored rehabilitation programs for individuals with Parkinson's disease. The project's progression is outlined as follows:
The first year: Design a standard AR environment based on Gentile's theory and establish test-retest reliability with 20 healthy subjects.
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
- 是
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
Frequency-Domain Index of HRV: High Frequency (HF)
时间窗: Baseline and 6 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.
Walking Speed
时间窗: Baseline and 6 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 and 6 weeks
The linear distance between the two ankles, typically expressed in centimeter(cm).
Step Time
时间窗: Baseline and 6 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 and 6 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 and 6 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 and 6 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 and 6 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: Ratio of LF to HF Power
时间窗: Baseline and 6 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 (TUG test)
时间窗: Baseline and 6 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
- Non-linear Index of HRV: Ratio of SD1-to-SD2(Baseline and 6 weeks)
- Double Support Time(Baseline and 6 weeks)
- Single Support Time(Baseline and 6 weeks)
- Swing Time(Baseline and 6 weeks)
- Stance Time(Baseline and 6 weeks)
- Total UPDRS-III Score(Baseline and 6 weeks)
- Total NFOG-Q Score(Baseline and 6 weeks)
- Cadence(Baseline and 6 weeks)
- Total HADS Score(Time Frame: Baseline and 6 weeks.)
- Non-linear Index of HRV: SD2(Baseline and 6 weeks)
- Overall PDQ-39 Score(Baseline and 6 weeks)
- Overall PSQI Score(Time Frame: Baseline and 6 weeks.)
- Non-linear Index of HRV: SD1(Baseline and 6 weeks)
研究者
Ya-Ju Chang
Professor
Chang Gung University