N/A
N=22
Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05160025 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback — 85.44 revolutions per minute (rpm) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual reality bicycling (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback |
85.44 | <0.001 sig |
| PRIMARY Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition |
92.97 | — |
| PRIMARY Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition |
93.83 | — |
| PRIMARY Motivation (Intrinsic Motivation Inventory) - Feedback |
6.06 | 0.111 |
| PRIMARY Motivation (Intrinsic Motivation Inventory) - Self-Competition |
6.13 | — |
| PRIMARY Motivation (Intrinsic Motivation Inventory) - Other-Competition |
6.11 | — |
| PRIMARY Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Feedback |
109.26 | <0.001 sig |
| PRIMARY Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition |
115.41 | — |
| PRIMARY Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition |
114.42 | — |
| PRIMARY 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 |
76.70 | > 0.05 |
| PRIMARY 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 |
79.20 | — |
| PRIMARY 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 |
77.89 | — |
| SECONDARY Rating of Perceived Exertion - Feedback (Start) |
8.43 | — |
| SECONDARY Rating of Perceived Exertion - Feedback (Middle) |
12.62 | — |
| SECONDARY Rating of Perceived Exertion - Feedback (End) |
14.0 | 0.004 sig |
| SECONDARY Rating of Perceived Exertion - Self-Competition (Start) |
8.67 | — |
| SECONDARY Rating of Perceived Exertion - Self-Competition (Middle) |
13.81 | — |
| SECONDARY Rating of Perceived Exertion - Self-Competition (End) |
15.57 | — |
| SECONDARY Rating of Perceived Exertion - Other-Competition (Start) |
9.0 | — |
| SECONDARY Rating of Perceived Exertion - Other-Competition (Middle) |
13.57 | — |
| SECONDARY Rating of Perceived Exertion - Other-Competition (End) |
15.0 | — |
| SECONDARY Competitiveness (Multidimensional Competitive Orientation Inventory) |
2.4; 2.3; 2.0; 4.3 | — |
| SECONDARY Ranking of Perceived Effort |
11; 8; 2 | > 0.05 |
| SECONDARY Ranking of Enjoyment |
8; 7; 6 | > 0.05 |
| SECONDARY Audio Recordings of Exercise Experience |
— | — |
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
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).
Data sourced from ClinicalTrials.gov (NCT05160025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.