A Novel Virtual Reality Task in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Pixel Plucker
Rock Steady Boxing
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- NYITRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Boxing
Virtual Reality Pixel Plucker
Arm Description
Rock Steady Boxing
30 minutes of VR engagement
Outcomes
Primary Outcome Measures
Stroop Test, Inquisit Millisecond
measure of executive function
Secondary Outcome Measures
Full Information
NCT ID
NCT05859308
First Posted
March 28, 2023
Last Updated
July 24, 2023
Sponsor
New York Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT05859308
Brief Title
A Novel Virtual Reality Task in Parkinson's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Institute of Technology
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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Boxing
Arm Type
Active Comparator
Arm Description
Rock Steady Boxing
Arm Title
Virtual Reality Pixel Plucker
Arm Type
Experimental
Arm Description
30 minutes of VR engagement
Intervention Type
Other
Intervention Name(s)
Virtual Reality Pixel Plucker
Intervention Description
A virtual reality task where participants wear the Virtual Reality headset and respond to targets.
Intervention Type
Other
Intervention Name(s)
Rock Steady Boxing
Intervention Description
An in-person boxing class designed for individuals with Parkinson's disease.
Primary Outcome Measure Information:
Title
Stroop Test, Inquisit Millisecond
Description
measure of executive function
Time Frame
through study completion, an average of one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Sousa, PhD
Phone
516-686-7698
Email
asousa@nyit.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Sousa, PhD
Organizational Affiliation
NYIT
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYIT
City
Old Westbury
State/Province
New York
ZIP/Postal Code
11568
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Sousa, PhD
Phone
631-686-7698
Email
asousa@nyit.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Novel Virtual Reality Task in Parkinson's Disease
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