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

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

Study Locations

    • New York
      • Old Westbury, New York, United States, 11568
        • Recruiting
        • NYIT
        • Contact:

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.

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

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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