Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease

NCT05160025 | Completed Results DMC

• 3 other identifiers: Pro20210014121F30AG072807-011R15AG063348-01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (12)

• Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback

  Bicycling cadence collected continuously (1 value per second, 1 Hz)

  Session 1 - During the 8-minute feedback bout

• Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition

  Bicycling cadence collected continuously (1 value per second, 1 Hz)

  Session 1 - During the 8-minute self-competition bout

• Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition

  Bicycling cadence collected continuously (1 value per second, 1 Hz)

  Session 1 - During the 8-minute other-competition bout

• Motivation (Intrinsic Motivation Inventory) - Feedback

  Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.

  Session 1 - Immediately after completing the 8-minute feedback bout

• Motivation (Intrinsic Motivation Inventory) - Self-Competition

  Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.

  Session 1 - Immediately after completing the 8-minute self-competition bout

• Motivation (Intrinsic Motivation Inventory) - Other-Competition

  Intrinsic Motivation Inventory - enjoyment, competence, effort, and value subscales (16 questions total). Scores in each subscale are averaged, with a minimum score of 1 and a maximum score of 7. Higher scores indicate higher motivation.

  Session 1 - Immediately after completing the 8-minute other-competition bout

• Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Feedback

  Heart rate collected continuously (1 value per second, 1 Hz)

  Session 1 - During the 8-minute feedback bout

• Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition

  Heart rate collected continuously (1 value per second, 1 Hz)

  Session 1 - During the 8-minute self-competition bout

• Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition

  Heart rate collected continuously (1 value per second, 1 Hz)

  Session 1 - During the 8-minute other-competition bout

• Visual Attention (Infrared Eye-tracking Data Representing Gaze Positions in a 3D Coordinate Plane to be Used in Calculating Dwell Time in Regions of Interest in the Virtual Simulation) - Feedback

  3D gaze positions are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%).

  Session 1 - During the 8-minute feedback bout

• Visual Attention (Infrared Eye-tracking Data Representing Gaze Positions in a 3D Coordinate Plane to be Used in Calculating Dwell Time in Regions of Interest in the Virtual Simulation) - Self-Competition

  3D gaze positions are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%).

  Session 1 - During the 8-minute self-competition bout

• Visual Attention (Infrared Eye-tracking Data Representing Gaze Positions in a 3D Coordinate Plane to be Used in Calculating Dwell Time in Regions of Interest in the Virtual Simulation) - Other-Competition

  3D gaze positions are measured continuously (40 values per second, 40 Hz) and valid gaze datapoints are extracted. The percentage of total valid gaze datapoints that are directed to the task are calculated as a metric of visual attention. A higher percentage reflects higher task focus, meaning that the higher percentage the higher degree of focus on the task. The reported value is measured as a percentage (%).

  Session 1 - During the 8-minute other-competition bout

Secondary Outcomes (13)

• Rating of Perceived Exertion - Feedback (Start)

  Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout

• Rating of Perceived Exertion - Feedback (Middle)

  Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout

• Rating of Perceived Exertion - Feedback (End)

  Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout

• Rating of Perceived Exertion - Self-Competition (Start)

  Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout

• Rating of Perceived Exertion - Self-Competition (Middle)

  Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout

Other Outcomes (3)

• UPDRS-III Subscale

  Collected once at start of the session (Repeat of Baseline Outcome Measure)

• Physical Activity Scale for the Elderly

  Collected once at start of the session (Repeat of Baseline Outcome Measure)

• Geriatric Depression Scale (Short Form)

  Collected once during screening (Repeat of Baseline Outcome Measure)

Study Arms (1)

Virtual Reality Bicycling

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.

Other: Virtual reality bicycling

Interventions

Virtual reality bicycling 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.

Virtual Reality Bicycling

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rutgers School of Health Professions

Newark, New Jersey, 07107, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The primary limitations are related to: setting of the baseline and target cadence, participants setting personal goals for themselves that could emulate self-competitive behavior in the competition against others condition, and operational definitions for measures of visual attention. Other limitations: the sample of persons was recruited mostly from support groups and exercise classes in the area. Therefore, it is possible that participants were aware of the benefits of exercise.

Results Point of Contact

• Title: Dr. John Palmieri, Study Coordinator
• Organization: Rutgers University

john.palmieri@rutgers.edu

9733562378

Study Officials

• Judith E Deutsch

  Rutgers School of Health Professions

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rehabilitation & Movement Sciences

Model Details: Repeated measures design

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: December 16, 2021
• Study Start: October 27, 2022
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The investigators will make study data available immediately following completion.
• Access Criteria: Open Access

Locations

US (1)