Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

NCT ID: NCT05160025

Last Updated: 2023-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2023-02-17

Brief Summary

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This study has three objectives about persons with Parkinson's Disease during bicycling:

1. Determine the effect of visual feedback and competition during virtual bicycling on neuromuscular and cardiovascular intensity
2. Determine the effect of visual-feedback and competition during virtual bicycling on the user experience of motivation, enjoyment \& perception of exercise intensity
3. Determine if attention differs during visual feedback compared to competition virtual bicycling

Detailed Description

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Participants will attend one sessions lasting about 2-3 hours. They will complete movement assessments and questionnaires about physical activity. They will then exercise exercise in three different virtual reality augmented bicycling conditions while wearing a head mounted display (goggles). Each of the three conditions will last approximately 8 minutes and will be followed by questionnaires about the participant's experience.

Conditions

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Parkinson Disease

Keywords

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parkinson disease parkinsonian disorders Basal ganglia disease Brain diseases central nervous system diseases nervous system diseases movement disorders synucleinopathies neurodegenerative diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Repeated measures design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Virtual Reality Bicycling

This is a single arm study in which all participants will execute the same three bicycling tasks over one session. Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 8 minutes each.

Group Type OTHER

Virtual reality bicycling

Intervention Type OTHER

This is a single arm study in which all participants will execute the same three bicycling tasks over one session. Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 8 minutes each.

Interventions

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Virtual reality bicycling

This is a single arm study in which all participants will execute the same three bicycling tasks over one session. Exercise intensity and enjoyment are measured while participants bicycle in a virtual reality environment (wearing virtual reality goggles) in three different conditions lasting approximately 8 minutes each.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Parkinson's disease following the UK Brain Bank Diagnostic Criteria,
* Hoehn and Yahr stages II-III,
* 45-80 years old,
* Able to ride a stationary upright bicycle,
* Able to sign informed consent.

Exclusion Criteria

* Have a recent history of severe heart disease, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than Parkinson Disease,
* Are unable to follow directions or sign a consent form,
* Do not have adequate vision or hearing ability to see or hear a television,
* Have unstable medical condition or musculoskeletal disorder such as severe arthritis, recent knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to ride the bicycle,
* Have any other medical condition that prevents bicycling,
* Have moderate depression (score of 9 or more on GDS screening tool).
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Judith E Deutsch, PT, PhD

Professor, Department of Rehabilitation & Movement Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judith E Deutsch

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Health Professions

Locations

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Rutgers School of Health Professions

Newark, New Jersey, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1F30AG072807-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R15AG063348-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2021001412

Identifier Type: -

Identifier Source: org_study_id