A Novel Virtual Reality Task in Parkinson's Disease | NCT05859308

Studies
A Novel Virtual Reality Task in Parkinson's Disease

NCT05859308

Sponsor

New York Institute of Technology

Status

Unknown status

Last Update Posted

Jul 27, 2023Actual

Enrollment

6Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Virtual Reality Pixel Plucker
Rock Steady Boxing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

May 15, 2024Estimated

Completion Date

May 15, 2024Estimated

First Submitted Date

Mar 28, 2023

First Submission Date that Met QC Criteria

May 13, 2023

First Posted Date

May 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2023

Last Update Posted Date

Jul 27, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amber Sousa, Assistant Professor, Neuropsychologist, New York Institute of TechnologyPrincipal Investigator

Lead Sponsor

New York Institute of TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Boxing	Active Comparator	Rock Steady Boxing	Other: Rock Steady Boxing
Virtual Reality Pixel Plucker	Experimental	30 minutes of VR engagement	Other: Virtual Reality Pixel Plucker

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual Reality Pixel Plucker	Other	A virtual reality task where participants wear the Virtual Reality headset and respond to targets.	Virtual Reality Pixel Plucker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroop Test, Inquisit Millisecond	measure of executive function	through study completion, an average of one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amber Sousa, PhD	Contact	516-686-7698		asousa@nyit.edu

Overall Officials

Name	Affiliation	Role
Amber Sousa, PhD	NYIT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYIT	Recruiting	Old Westbury	New York	11568	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided