Clinical trial NCT06367101: AR Stimulation Effects on Gait, Anxiety, and Brain Connectivity in Parkinson's Disease
Official title: Investigate the Effect of AR Environment Stimulation on Gait, Anxiety and Brain Connectivity of Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease(PD)
Keywords: Augmented Reality
Heart rate variability
Gait
Stress
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

The second year: Test 30 individuals with PD in both real and AR environments to establish the relationship between different environmental stimuli for PD patients.

The third year: Randomize 30 individuals with PD into the AR training group and a control group. Evaluate the distinct training effects, with a focus on gait performance, gait initiation, freezing of gait, and anxiety levels.

Eligibility criteria: Health subjects:

Exclusion Criteria:

* Musculoskeletal injuries on legs.
* Osteoporosis.

PD subjects:

Inclusion Criteria:

- Clinical diagnosis of Parkinson disease.

Exclusion Criteria:

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

Primary outcomes:
measure: Walking Speed
timeFrame: Baseline and 6 weeks
measure: Step Length
timeFrame: Baseline and 6 weeks
measure: Step Time
timeFrame: Baseline and 6 weeks
measure: Time-Domain Index of Heart Rate Variability (HRV)：Standard deviation of RR intervals (SDRR)
timeFrame: Baseline and 6 weeks
measure: Time-Domain Index of HRV：pNN50
timeFrame: Baseline and 6 weeks
measure: Time-Domain Index of HRV：Root mean square of successive RR interval differences (RMSSD)
timeFrame: Baseline and 6 weeks
measure: Frequency-Domain Index of HRV: Low Frequency (LF)
timeFrame: Baseline and 6 weeks
measure: Frequency-Domain Index of HRV: High Frequency (HF)
timeFrame: Baseline and 6 weeks
measure: Frequency-Domain Index of HRV: Ratio of LF to HF Power
timeFrame: Baseline and 6 weeks
measure: Total Time to Complete the Time Up and Go test (TUG test)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Double Support Time
timeFrame: Baseline and 6 weeks
measure: Single Support Time
timeFrame: Baseline and 6 weeks
measure: Swing Time
timeFrame: Baseline and 6 weeks
measure: Stance Time
timeFrame: Baseline and 6 weeks
measure: Cadence
timeFrame: Baseline and 6 weeks
measure: Total UPDRS-III Score
timeFrame: Baseline and 6 weeks
measure: Total NFOG-Q Score
timeFrame: Baseline and 6 weeks
measure: Overall PDQ-39 Score
timeFrame: Baseline and 6 weeks
measure: Total HADS Score
timeFrame: Time Frame: Baseline and 6 weeks.
measure: Overall PSQI Score
timeFrame: Time Frame: Baseline and 6 weeks.
measure: Non-linear Index of HRV: SD1
timeFrame: Baseline and 6 weeks
measure: Non-linear Index of HRV: SD2
timeFrame: Baseline and 6 weeks
measure: Non-linear Index of HRV: Ratio of SD1-to-SD2
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: