Back to resultsImmersive Virtual Reality Bicycling for Persons With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual reality bicycling
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring parkinson disease, parkinsonian disorders, Basal ganglia disease, Brain diseases, central nervous system diseases, nervous system diseases, movement disorders, synucleinopathies, neurodegenerative diseases
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).
Sites / Locations
- Rutgers School of Health Professions
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Virtual Reality Bicycling
Arm Description
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.
Outcomes
Primary Outcome Measures
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Feedback
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Self-Competition
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Other-Competition
Bicycling cadence collected continuously (1 value per second, 1 Hz)
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.
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.
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.
Cardiovascular Intensity (Heart rate, beats per minute) - Feedback
Heart rate collected continuously (1 value per second, 1 Hz)
Cardiovascular Intensity (Heart rate, beats per minute) - Self-Competition
Heart rate collected continuously (1 value per second, 1 Hz)
Cardiovascular Intensity (Heart rate, beats per minute) - Other-Competition
Heart rate collected continuously (1 value per second, 1 Hz)
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 measured continuously (40 values per second, 40 Hz)
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 measured continuously (40 values per second, 40 Hz)
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 measured continuously (40 values per second, 40 Hz)
Secondary Outcome Measures
Rating of Perceived Exertion - Feedback (start)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Feedback (middle)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Feedback (end)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Self-Competition (start)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Self-Competition (middle)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Self-Competition (end)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Other-Competition (start)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Other-Competition (middle)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Rating of Perceived Exertion - Other-Competition (end)
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Competitiveness (Multidimensional Competitive Orientation Inventory)
Measured once using the Multidimensional Competitive Orientation Inventory consisting of 12 items from 4 subscales (hyper competitive, self-developmental, anxious, lack of interest) For each subscale, mean scores range from 1-6 with higher scores representing higher levels of that subscale metric.
Ranking of Perceived Effort
Once, after completing all 3 bicycling conditions, participants will be asked in which of the 3 bicycling conditions they felt they worked the hardest. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition in which they felt they worked the hardest and a 3 indicating the condition in which they felt they worked the least hard.
Ranking of Enjoyment
Once, after completing all 3 bicycling conditions, participants will be asked which of the 3 bicycling conditions they liked the best. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition they liked the best and a 3 indicating the condition they liked the least.
Audio recordings of exercise experience
Once, after completing all 3 bicycling conditions, participants will be asked about their exercise experience. Their responses will be audio recorded to be coded and analyzed qualitatively for themes.
Full Information
NCT ID
NCT05160025
First Posted
October 26, 2021
Last Updated
March 3, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05160025
Brief Title
Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease
Official Title
Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2022 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study has three objectives about persons with Parkinson's Disease during bicycling:
Determine the effect of visual feedback and competition during virtual bicycling on neuromuscular and cardiovascular intensity
Determine the effect of visual-feedback and competition during virtual bicycling on the user experience of motivation, enjoyment & perception of exercise intensity
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson disease, parkinsonian disorders, Basal ganglia disease, Brain diseases, central nervous system diseases, nervous system diseases, movement disorders, synucleinopathies, neurodegenerative diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Repeated measures design
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Bicycling
Arm Type
Other
Arm Description
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
Intervention Name(s)
Virtual reality bicycling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Feedback
Description
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Time Frame
Session 1 - During the 8-minute feedback bout
Title
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Self-Competition
Description
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Time Frame
Session 1 - During the 8-minute self-competition bout
Title
Neuromuscular Intensity (Bicycling cadence, revolutions per minute) - Other-Competition
Description
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Time Frame
Session 1 - During the 8-minute other-competition bout
Title
Motivation (Intrinsic Motivation Inventory) - Feedback
Description
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.
Time Frame
Session 1 - Immediately after completing the 8-minute feedback bout
Title
Motivation (Intrinsic Motivation Inventory) - Self-Competition
Description
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.
Time Frame
Session 1 - Immediately after completing the 8-minute self-competition bout
Title
Motivation (Intrinsic Motivation Inventory) - Other-Competition
Description
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.
Time Frame
Session 1 - Immediately after completing the 8-minute other-competition bout
Title
Cardiovascular Intensity (Heart rate, beats per minute) - Feedback
Description
Heart rate collected continuously (1 value per second, 1 Hz)
Time Frame
Session 1 - During the 8-minute feedback bout
Title
Cardiovascular Intensity (Heart rate, beats per minute) - Self-Competition
Description
Heart rate collected continuously (1 value per second, 1 Hz)
Time Frame
Session 1 - During the 8-minute self-competition bout
Title
Cardiovascular Intensity (Heart rate, beats per minute) - Other-Competition
Description
Heart rate collected continuously (1 value per second, 1 Hz)
Time Frame
Session 1 - During the 8-minute other-competition bout
Title
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
Description
3D gaze positions measured continuously (40 values per second, 40 Hz)
Time Frame
Session 1 - During the 8-minute feedback bout
Title
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
Description
3D gaze positions measured continuously (40 values per second, 40 Hz)
Time Frame
Session 1 - During the 8-minute self-competition bout
Title
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
Description
3D gaze positions measured continuously (40 values per second, 40 Hz)
Time Frame
Session 1 - During the 8-minute other-competition bout
Secondary Outcome Measure Information:
Title
Rating of Perceived Exertion - Feedback (start)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout
Title
Rating of Perceived Exertion - Feedback (middle)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout
Title
Rating of Perceived Exertion - Feedback (end)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout
Title
Rating of Perceived Exertion - Self-Competition (start)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout
Title
Rating of Perceived Exertion - Self-Competition (middle)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout
Title
Rating of Perceived Exertion - Self-Competition (end)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout
Title
Rating of Perceived Exertion - Other-Competition (start)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout
Title
Rating of Perceived Exertion - Other-Competition (middle)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout
Title
Rating of Perceived Exertion - Other-Competition (end)
Description
Borg scale measures a self-report of effort collected at multiple time points to compare the 3 exercise bouts. The score ranges from 6-20 with higher scores representing higher perceived exertion.
Time Frame
Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout
Title
Competitiveness (Multidimensional Competitive Orientation Inventory)
Description
Measured once using the Multidimensional Competitive Orientation Inventory consisting of 12 items from 4 subscales (hyper competitive, self-developmental, anxious, lack of interest) For each subscale, mean scores range from 1-6 with higher scores representing higher levels of that subscale metric.
Time Frame
Measured once before exercise bouts begin (after clinical assessments)
Title
Ranking of Perceived Effort
Description
Once, after completing all 3 bicycling conditions, participants will be asked in which of the 3 bicycling conditions they felt they worked the hardest. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition in which they felt they worked the hardest and a 3 indicating the condition in which they felt they worked the least hard.
Time Frame
Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Title
Ranking of Enjoyment
Description
Once, after completing all 3 bicycling conditions, participants will be asked which of the 3 bicycling conditions they liked the best. They will rank the 3 conditions with a score from 1-3, with a 1 indicating the condition they liked the best and a 3 indicating the condition they liked the least.
Time Frame
Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Title
Audio recordings of exercise experience
Description
Once, after completing all 3 bicycling conditions, participants will be asked about their exercise experience. Their responses will be audio recorded to be coded and analyzed qualitatively for themes.
Time Frame
Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Other Pre-specified Outcome Measures:
Title
UPDRS-III Subscale
Description
Description of Motor Performance Scored from 0-108 a lower score is better outcome
Time Frame
Collected once at start of the session
Title
Physical Activity Scale for the Elderly
Description
Exercise Inventory Questionnaire to measure levels of physical activity. Scores range from 0-793, and higher scores represent higher levels of physical activity over the past 7 days.
Time Frame
Collected once at start of the session
Title
Geriatric Depression Scale (short form)
Description
15 item inventory to rate depression (scored from 0-15 with a lower score being better)
Time Frame
Collected once during screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith E Deutsch
Organizational Affiliation
Rutgers School of Health Professions
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers School of Health Professions
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Immediately following completion of the proposed study the investigators will submit a de-identified data set of the protocol and links to published papers.
IPD Sharing Time Frame
The investigators will make study data available immediately following completion.
IPD Sharing Access Criteria
Open Access
Learn more about this trial
Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease
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