AR Gait Training for Parkinson's Disease

Effect of AR Environment Stimulation on Proactive and Reactive Modulation of Gait in Individuals With Parkinson Disease

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.

Study Overview

• Status: Recruiting
• Conditions: PD - Parkinson's Disease
• Intervention / Treatment: Procedure: AR gait training

Detailed Description

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:

1. Test the AR environment stimulation on classifying patients and establish the relationships among challenging AR environment, pressure, and gait
2. Investigate the effects of interactive AR gait training on gait and stress for individuals with PD.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung University
    • Contact: Ya-Ju Chang, PhD; Phone Number: 5515 88632118800; Email: yjchang@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

• Musculoskeletal injuries on legs
• Osteoporosis.
• Any peripheral or central nervous system injury or disease patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PD patients; AR gait training	Procedure: AR gait training; Participants will walk on a pathway projected in augmented reality (AR), following the instructions provided on the pathway Each session will last for 60 minutes, conducted three times per week, over a period of six weeks.
No Intervention: PD patients (Control); Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed	The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).	Baseline, 6 weeks, 8 weeks
Step Length	The linear distance between the two ankles, typically expressed in centimeter(cm).	Baseline, 6 weeks, 8 weeks
Step Time	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.	Baseline, 6 weeks, 8 weeks
Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR)	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.	Baseline, 6 weeks, 8 weeks
Time-Domain Index of HRV：pNN50	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.	Baseline, 6 weeks, 8 weeks
Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD)	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	Baseline, 6 weeks, 8 weeks
Frequency-Domain Index of HRV: Low Frequency (LF)	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,	Baseline, 6 weeks, 8 weeks
Frequency-Domain Index of HRV: High Frequency (HF)	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.	Baseline, 6 weeks, 8 weeks
Frequency-Domain Index of HRV: Ratio of LF to HF Power	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	Baseline, 6 weeks, 8 weeks
Total Time to Complete the Time Up and Go test	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.	Baseline, 6 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Double Support Time	The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.	Baseline, 6 weeks, 8 weeks
Single Support Time	The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle	Baseline, 6 weeks, 8 weeks
Swing Time	The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.	Baseline, 6 weeks, 8 weeks
Stance Time	The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds	Baseline, 6 weeks, 8 weeks
Cadence	The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, expressed as steps per minute.	Baseline, 6 weeks, 8 weeks
Total UPDRS-III Score	The Unified Parkinson's Disease Rating Scale (UPDRS) Part III, also known as the UPDRS-III or the Motor Examination, is a critical component of the UPDRS used to assess the motor symptoms of Parkinson's disease (PD). To provide a comprehensive assessment of motor function in individuals with Parkinson's disease, covering aspects such as bradykinesia (slowness of movement), rigidity, tremors, and postural instability. The UPDRS-III consists of 14 items, each rated on a scale from 0 (normal) to 4 (severe), with a total possible score range from 0 to 108. Higher scores indicate greater motor impairment.	Baseline, 6 weeks, 8 weeks
Total NFOG-Q Score	The New Freezing of Gait Questionnaire (NFOG-Q) is a specialized tool designed to quantify the severity and impact of freezing of gait (FOG) episodes in individuals with Parkinson's disease (PD). To assess the presence, severity, and impact of FOG in individuals with Parkinson's disease, focusing on how it affects daily activities and mobility. The scores from Parts 2 and 3 are used to calculate a total score that reflects the overall severity and impact of FOG. This total score can help in gauging the effectiveness of treatments aimed at reducing the severity or frequency of FOG episodes.	Baseline, 6 weeks, 8 weeks
Overall PDQ-39 Score	To evaluate the quality of life across multiple dimensions affected by Parkinson's disease, including mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. The PDQ-39 consists of 39 items, with each item relating to an aspect of life potentially impacted by PD. Responses to these items are aggregated into eight scales corresponding to the dimensions mentioned above.Each item is scored on a scale from 0 (never) to 4 (always), with the total score for each dimension being converted to a 0-100 scale. A higher score indicates a lower quality of life.	Baseline, 6 weeks, 8 weeks
Total HADS Score	The Hospital Anxiety and Depression Scale (HADS) is a validated instrument designed to identify and quantify the severity of anxiety and depression symptoms, particularly focusing on the psychological rather than the somatic aspects to avoid confounding with physical illnesses. To screen for, and evaluate the severity of, anxiety and depression symptoms in a wide range of healthcare settings, especially useful in populations where physical illness might overlap with psychological distress. The scores for each subscale (anxiety and depression) range from 0 to 21. These can be combined to give a total HADS score, which ranges from 0 to 42, with higher scores indicating more severe symptoms.	Baseline, 6 weeks, 8 weeks
Overall PSQI Score	The Pittsburgh Sleep Quality Index (PSQI) is a comprehensive self-rated questionnaire that assesses sleep quality and disturbances over the past month. To evaluate the quality and patterns of sleep, identifying sleep disorders and quantifying the degree of sleep-related problems. Each component is scored on a scale of 0 to 3, with the total PSQI score ranging from 0 to 21. Higher scores indicate poorer sleep quality.	Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: SD1	SD1 is calculated from the Poincaré plot, where it measures the dispersion of points perpendicular to the line of identity, usually expressed in milliseconds. This dispersion specifically quantifies the short-term variability in heart rate, primarily influenced by the parasympathetic nervous system. SD1 provides insight into the rapid changes in heart rate variability, offering a unique perspective on autonomic nervous system activity that traditional time-domain and frequency-domain measures might not fully capture.	Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: SD2	SD2 is calculated as the standard deviation of points along the line of identity in the Poincaré plot, reflecting long-term heart rate variability, usually expressed in milliseconds. This measure captures broader fluctuations in heart rate that are influenced by both sympathetic and parasympathetic nervous system activities. SD2 provides insights into the overall autonomic balance and the body's ability to adapt to sustained physiological stressors or environmental changes. It is particularly useful in studies investigating chronic stress, cardiovascular health, or the impact of long-term interventions.	Baseline, 6 weeks, 8 weeks
Non-linear Index of HRV: Ratio of SD1-to-SD2	The SD1/SD2 ratio is calculated by dividing SD1, which measures short-term variability and is predominantly influenced by parasympathetic activity, by SD2, which measures long-term variability and reflects both sympathetic and parasympathetic influences. This ratio is useful for assessing the autonomic balance or the sympathetic-parasympathetic interaction. A higher SD1/SD2 ratio indicates a dominance of parasympathetic activity relative to sympathetic, suggesting a more "relaxed" autonomic state, whereas a lower ratio indicates a relative dominance of sympathetic activity, which could be associated with stress, reduced cardiac health, or other health risks.	Baseline, 6 weeks, 8 weeks
Total Montreal Cognitive Assessment (MoCA) Score	The MoCA is a widely used cognitive screening tool that assesses multiple cognitive domains, including attention, memory, executive functions, language, visuospatial abilities, and orientation	Baseline, 6 weeks, 8 weeks
Total Mini-Mental State Examination (MMSE) Score	The MMSE is a widely used cognitive screening tool designed to assess global cognitive function across several domains, including orientation, registration, attention, calculation, recall, and language	Baseline, 6 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Augmented Reality; Heart Rate Variability (HRV); Gait Taining
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No