Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

NCT ID: NCT05160025

Last Updated: 2023-12-22

Basic Information

• 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

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

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

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

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

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Judith E Deutsch, PT, PhD

Professor, Department of Rehabilitation & Movement Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith E Deutsch

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Health Professions

Locations

Rutgers School of Health Professions

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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