AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease

NCT06367101 | Recruiting

• 1 other identifier: 202002525B0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease(PD)

Keywords

Augmented Reality; Heart rate variability; Gait; Stress

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 and 6 weeks

• Step Length

  The linear distance between the two ankles, typically expressed in centimeter(cm).

  Baseline and 6 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 and 6 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 and 6 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 and 6 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 and 6 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 and 6 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 and 6 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 and 6 weeks

• Total Time to Complete the Time Up and Go test (TUG 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 and 6 weeks

Secondary Outcomes (13)

• 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

• Cadence

  Baseline and 6 weeks

Study Arms (4)

Stage 1:Healthy people

NO INTERVENTION

To establish baseline and reliability.

Stage 2: PD people

NO INTERVENTION

To establish stage 3 training protocol.

Stage 3: PD AR training group

EXPERIMENTAL

AR training with gait and HRV feedback

Other: AR training with gait and HRV feedback

Stage 3: PD Control group

NO INTERVENTION

PD Control

Interventions

AR training with gait and HRV feedback OTHER

Use projection-based AR system to train gait and HRV. To give gait and HRV feedback for subjects after AR training.

Also known as: AR training group

Stage 3: PD AR training group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Musculoskeletal injuries on legs.
• Osteoporosis.
• PD subjects:
• \- Clinical diagnosis of Parkinson disease.
• 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

Interventions

Gait

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ya-Ju Chang, PhD

CONTACT

+88632118800; yjchang@mail.cgu.edu.tw

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: March 28, 2024
• First Posted: April 16, 2024
• Study Start: January 18, 2022
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)