Parkinson DiseaseNCT05859308
A Novel Virtual Reality Task in Parkinson's Disease
A study testing Virtual Reality Pixel Plucker and Rock Steady Boxing in people with Parkinson Disease, run by New York Institute of Technology at 1 site in United States.
Trial summary
The purpose of this study is to compare experiences and effects of a virtual reality physical program to an in-person Rock Steady Boxing Program. People with Parkinson's disease, age 18 and up, who participate in Rock Steady Boxing weekly may join this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual Reality Pixel Plucker and Rock Steady Boxing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Parkinson's disease
- Age 18+ years
- Currently involved in rock steady boxing
- Willing to participate 2-3 days/week
Who cannot join
- Known history of movement-induced vertigo
- Other cognitive or movement disorders
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NYIT
Old Westbury, New York, 11568
Amber Sousa, PhD, 631-686-7698, asousa@nyit.edu
About this study
Official title: A Crossover Pilot Study of a Novel Virtual Reality Task in Parkinson's Disease Compared to a Group In-Person Rock Steady Boxing Program; Task Performance, Cognitive Outcomes, Perceptions, and Comparisons
The purpose of this study is to compare experiences and effects of a virtual reality physical program to an in-person Rock Steady Boxing Program. People with Parkinson's disease, age 18 and up, who participate in Rock Steady Boxing weekly may join this study.
Read the detailed description
If you agree to be in this study, we will ask you to do the following things:
Provide basic information about yourself, complete tests of thinking on the computer and in person, participate in your regular Rock Steady boxing, and for three weeks replace your Rock Steady Boxing with a virtual reality game done with a headset. You will work independently with a study team member.
- Visit 1 or Visit 1 and 2 if split up: Beginning Measures/Demographics, Parkinson's disease symptoms, Cognition (about 45 minutes), VR training (30 minutes) or Regular Rock Steady Boxing (1 hour)
- Visit 2-5: Virtual Reality training (30 minutes or Regular Rock Steady Boxing (1 hour)
- Visit 6: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive measures (about 20 minutes)
- Visit 7: Cognitive measures (about 20 minutes), Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour); Intrinsic Motivation Inventory (5 minutes)
- Visit 8-11: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour)
- Visit 12 or Visit 13 if baseline was split up: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive Measures (20 minutes), Intrinsic Motivation Inventory (5 minutes), End of Study Survey (5-10 minutes)
- Conditions
- Parkinson Disease
- Being tested
- Virtual Reality Pixel Plucker, Rock Steady Boxing
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Pixel PluckerOther
A virtual reality task where participants wear the Virtual Reality headset and respond to targets.
Rock Steady BoxingOther
An in-person boxing class designed for individuals with Parkinson's disease.
| Study group | Role | What they receive |
|---|---|---|
| Boxing | Active comparator | Rock Steady Boxing Receives: Other: Rock Steady Boxing |
| Virtual Reality Pixel Plucker | Experimental | 30 minutes of VR engagement Receives: Other: Virtual Reality Pixel Plucker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Test, Inquisit Millisecond
measure of executive function
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start15 May 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Sousa, New York Institute of Technology
- Investigators
- Amber Sousa, PhD, Principal investigator, NYIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859308
- Sponsor's protocol ID
- BHS-1843
- Status last verified
- Jul 2023
- First submitted
- 28 Mar 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Pilot Study of a Novel Virtual Reality Task in Parkinson's Disease Compared to a Group In-Person Rock Steady Boxing Program; Task Performance, Cognitive Outcomes, Perceptions, and Comparisons
- ClinicalTrials.gov ID
- NCT05859308
- Acronym / sponsor ID
- BHS-1843
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare experiences and effects of a virtual reality physical program to an in-person Rock Steady Boxing Program. People with Parkinson's disease, age 18 and up, who participate in Rock Steady Boxing weekly may join this study.
Detailed description
If you agree to be in this study, we will ask you to do the following things:
Provide basic information about yourself, complete tests of thinking on the computer and in person, participate in your regular Rock Steady boxing, and for three weeks replace your Rock Steady Boxing with a virtual reality game done with a headset. You will work independently with a study team member.
- Visit 1 or Visit 1 and 2 if split up: Beginning Measures/Demographics, Parkinson's disease symptoms, Cognition (about 45 minutes), VR training (30 minutes) or Regular Rock Steady Boxing (1 hour)
- Visit 2-5: Virtual Reality training (30 minutes or Regular Rock Steady Boxing (1 hour)
- Visit 6: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive measures (about 20 minutes)
- Visit 7: Cognitive measures (about 20 minutes), Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour); Intrinsic Motivation Inventory (5 minutes)
- Visit 8-11: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour)
- Visit 12 or Visit 13 if baseline was split up: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive Measures (20 minutes), Intrinsic Motivation Inventory (5 minutes), End of Study Survey (5-10 minutes)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boxing | Active comparator | Other: Rock Steady BoxingRock Steady Boxing |
| Virtual Reality Pixel Plucker | Experimental | Other: Virtual Reality Pixel Plucker30 minutes of VR engagement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with Parkinson's disease
- Age 18+ years
- Currently involved in rock steady boxing
- Willing to participate 2-3 days/week
Key exclusion criteria (2 listed)
- Known history of movement-induced vertigo
- Other cognitive or movement disorders
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 Pixel PluckerA virtual reality task where participants wear the Virtual Reality headset and respond to targets. | Other | Virtual Reality Pixel Plucker |
| Rock Steady BoxingAn in-person boxing class designed for individuals with Parkinson's disease. | Other | Boxing |
Primary outcome
Stroop Test, Inquisit Millisecond
Time frame: through study completion, an average of one year
measure of executive function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Amber Sousa, PhD principal investigator
NYIT
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 Pixel Plucker and Rock Steady Boxing in people with Parkinson Disease, run by New York Institute of Technology 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amber Sousa, PhD (516-686-7698, asousa@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroop Test, Inquisit Millisecond (time frame: through study completion, an average of one year). 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 27 Jul 2023.