- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05859308
A Novel Virtual Reality Task in Parkinson's Disease
July 24, 2023 updated by: Amber Sousa, New York Institute of Technology
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amber Sousa, PhD
- Phone Number: 516-686-7698
- Email: asousa@nyit.edu
Study Locations
-
-
New York
-
Old Westbury, New York, United States, 11568
- Recruiting
- NYIT
-
Contact:
- Amber Sousa, PhD
- Phone Number: 631-686-7698
- Email: asousa@nyit.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- Diagnosed with Parkinson's disease
- Age 18+ years
- Currently involved in rock steady boxing
- Willing to participate 2-3 days/week
Exclusion criteria:
- Known history of movement-induced vertigo
- Other cognitive or movement disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Boxing
Rock Steady Boxing
|
An in-person boxing class designed for individuals with Parkinson's disease.
|
|
Experimental: Virtual Reality Pixel Plucker
30 minutes of VR engagement
|
A virtual reality task where participants wear the Virtual Reality headset and respond to targets.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stroop Test, Inquisit Millisecond
Time Frame: through study completion, an average of one year
|
measure of executive function
|
through study completion, an average of one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amber Sousa, PhD, NYIT
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2023
Primary Completion (Estimated)
May 15, 2024
Study Completion (Estimated)
May 15, 2024
Study Registration Dates
First Submitted
March 28, 2023
First Submitted That Met QC Criteria
May 13, 2023
First Posted (Actual)
May 15, 2023
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 24, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BHS-1843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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