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

C

Chang Gung University

Status

Enrolling

Conditions

Parkinson Disease(PD)

Treatments

Other: AR training with gait and HRV feedback

Study type

Interventional

Funder types

Other

Identifiers

NCT06367101
202002525B0

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

90 participants in 4 patient groups

Stage 1:Healthy people
No Intervention group
Description:
To establish baseline and reliability.
Stage 2: PD people
No Intervention group
Description:
To establish stage 3 training protocol.
Stage 3: PD AR training group
Experimental group
Description:
AR training with gait and HRV feedback
Treatment:
Other: AR training with gait and HRV feedback
Stage 3: PD Control group
No Intervention group
Description:
PD Control

Trial contacts and locations

1

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Central trial contact

Ya-Ju Chang, PhD

Data sourced from clinicaltrials.gov

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