Parkinson DiseaseNCT05160025
Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease
A study testing Virtual reality bicycling in people with Parkinson Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual reality bicycling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers School of Health Professions
Newark, New Jersey, 07107
About this study
Official title: Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)
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
Read the 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
- Being tested
- Virtual reality bicycling
- Keywords
- parkinson disease, parkinsonian disorders, Basal ganglia disease, Brain diseases, central nervous system diseases, nervous system diseases, movement disorders, synucleinopathies, neurodegenerative diseases
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Movement Disorders, Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality bicyclingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual reality bicycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: Session 1 - During the 8-minute other-competition bout
Secondary outcomes (13)
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.
Measured: Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout
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.
Measured: Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout
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.
Measured: Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout
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.
Measured: Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout
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.
Measured: Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout
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.
Measured: Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout
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.
Measured: Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout
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.
Measured: Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout
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.
Measured: Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout
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.
Measured: Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure)
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.
Measured: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
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.
Measured: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Audio Recordings of Exercise Experience
Once, after completing all 3 bicycling conditions, participants will be asked about their exercise experience. Quantitative and qualitative analysis of recordings were not conducted. However, sample quotes representing constructs of the Intrinsic Motivation Inventory will be included in future publications.
Measured: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start27 Oct 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Repeated measures design
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Judith E Deutsch, PT, PhD, Rutgers, The State University of New Jersey
- Investigators
- Judith E Deutsch, Principal investigator, Rutgers School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160025
- Sponsor's protocol ID
- Pro2021001412
- Other IDs
- 1F30AG072807-01, 1R15AG063348-01
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2021
- Last updated
- 22 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Immediately following completion of the proposed study the investigators will submit a de-identified data set of the protocol and links to published papers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exercise Intensity, Motivation and Enjoyment for Persons With PD (VCycle-Competition)
- ClinicalTrials.gov ID
- NCT05160025
- Acronym / sponsor ID
- Pro2021001412
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, parkinsonian disorders, Basal ganglia disease, Brain diseases, central nervous system diseases, nervous system diseases, movement disorders, synucleinopathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 22 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Bicycling | Other | Other: Virtual reality bicyclingThis 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality bicyclingThis 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 |
Primary outcome
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback
Time frame: Session 1 - During the 8-minute feedback bout
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Self-Competition
Time frame: Session 1 - During the 8-minute self-competition bout
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Other-Competition
Time frame: Session 1 - During the 8-minute other-competition bout
Bicycling cadence collected continuously (1 value per second, 1 Hz)
Motivation (Intrinsic Motivation Inventory) - Feedback
Time frame: Session 1 - Immediately after completing the 8-minute feedback bout
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
Time frame: Session 1 - Immediately after completing the 8-minute self-competition bout
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
Time frame: Session 1 - Immediately after completing the 8-minute other-competition bout
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
Time frame: Session 1 - During the 8-minute feedback bout
Heart rate collected continuously (1 value per second, 1 Hz)
Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Self-Competition
Time frame: Session 1 - During the 8-minute self-competition bout
Heart rate collected continuously (1 value per second, 1 Hz)
Cardiovascular Intensity (Heart Rate, Beats Per Minute) - Other-Competition
Time frame: Session 1 - During the 8-minute other-competition bout
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
Time frame: Session 1 - During the 8-minute feedback bout
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 (%).
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
Time frame: Session 1 - During the 8-minute self-competition bout
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 (%).
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
Time frame: Session 1 - During the 8-minute other-competition bout
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 (%).
13 secondary outcomes
Rating of Perceived Exertion - Feedback (Start)
Time frame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute feedback bout
Rating of Perceived Exertion - Feedback (Middle)
Time frame: Session 1 - At the midpoint (4-minute mark) of the 8-minute feedback bout
Rating of Perceived Exertion - Feedback (End)
Time frame: Session 1 - At the endpoint (8-minute mark) of the 8-minute feedback bout
Rating of Perceived Exertion - Self-Competition (Start)
Time frame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute self-competition bout
Rating of Perceived Exertion - Self-Competition (Middle)
Time frame: Session 1 - At the midpoint (4-minute mark) of the 8-minute self-competition bout
Rating of Perceived Exertion - Self-Competition (End)
Time frame: Session 1 - At the end (8-minute mark) of the 8-minute self-competition bout
Rating of Perceived Exertion - Other-Competition (Start)
Time frame: Session 1 - Immediately at the start (0-minute mark) of the 8-minute other-competition bout
Rating of Perceived Exertion - Other-Competition (Middle)
Time frame: Session 1 - At the midpoint (4-minute mark) of the 8-minute other-competition bout
Rating of Perceived Exertion - Other-Competition (End)
Time frame: Session 1 - At the end (8-minute mark) of the 8-minute other-competition bout
Competitiveness (Multidimensional Competitive Orientation Inventory)
Time frame: Measured once before exercise bouts begin (after clinical assessments) (Repeat of Baseline Outcome Measure)
Ranking of Perceived Effort
Time frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Ranking of Enjoyment
Time frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Audio Recordings of Exercise Experience
Time frame: Session 1 - once at the end of the session. Collected upon study completion, immediately after finishing the final bicycling condition
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Immediately following completion of the proposed study the investigators will submit a de-identified data set of the protocol and links to published papers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith E Deutsch principal investigator
Rutgers School of Health Professions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality bicycling in people with Parkinson Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback (time frame: Session 1 - During the 8-minute feedback bout). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.