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

NCT ID: NCT06367101

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2025-07-31

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.

Conditions

Parkinson Disease(PD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stage 1:Healthy people

To establish baseline and reliability.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stage 2: PD people

To establish stage 3 training protocol.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stage 3: PD AR training group

AR training with gait and HRV feedback

Group Type: EXPERIMENTAL

AR training with gait and HRV feedback

Intervention Type: OTHER

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

Stage 3: PD Control group

PD Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AR training with gait and HRV feedback

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

Intervention Type: OTHER

Other Intervention Names

AR training group

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Parkinson disease.

Exclusion Criteria

• Musculoskeletal injuries on legs.
• Osteoporosis.

PD subjects:

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung University

OTHER

Sponsor Role: lead

Responsible Party

Ya-Ju Chang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chang Gung University

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ya-Ju Chang, PhD

Role: CONTACT

yjchang@mail.cgu.edu.tw

+88632118800 ext. 5515

Facility Contacts

Ya-Ju Chang, PhD

Role: primary

yjchang@mail.cgu.edu.tw

88632118800 ext. 5515

Other Identifiers

202002525B0

Identifier Type: -

Identifier Source: org_study_id