AR Gait Training for Parkinson's Disease

NCT06598878 | Recruiting

• 1 other identifier: PD_001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PD - Parkinson's Disease

Keywords

Augmented Reality; Gait Taining; Heart Rate Variability (HRV)

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (15)

• Double Support Time

  Baseline, 6 weeks, 8 weeks

• Single Support Time

  Baseline, 6 weeks, 8 weeks

• Swing Time

  Baseline, 6 weeks, 8 weeks

• Stance Time

  Baseline, 6 weeks, 8 weeks

• Cadence

  Baseline, 6 weeks, 8 weeks

Study Arms (2)

PD patients

EXPERIMENTAL

AR gait training

Procedure: AR gait training

PD patients (Control)

NO INTERVENTION

Control Group

Interventions

AR gait training PROCEDURE

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.

PD patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Clinical diagnosis of Parkinson disease.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TW (1)