Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367101
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-28
Brief Title:
AR Stimulation Effects on Gait Anxiety and Brain Connectivity in Parkinsons Disease
Sponsor:
Chang Gung University
Organization:
Chang Gung University
Study Overview
Official Title:
Investigate the Effect of AR Environment Stimulation on Gait Anxiety and Brain Connectivity of Individuals With Parkinson Disease
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A project aims at addressing gait impairments and non-motor symptoms such as anxiety and stress in Parkinsons 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 Parkinsons 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 Parkinsons 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 Gentiles 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 Parkinsons disease The projects progression is outlined as follows
The first year Design a standard AR environment based on Gentiles 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
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 Parkinsons 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 Gentiles 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 Parkinsons disease The projects progression is outlined as follows
The first year Design a standard AR environment based on Gentiles 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None