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Effect of Immersive Virtual Reality Exergames in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality exergames
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Virtual reality, Exergame

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed as idiopathic Parkinson's disease
  • Modified Hoehn & Yahr stage 2, 2.5, or 3

Exclusion Criteria:

  • Moderate to severe cognitive dysfunction with Mini-mental State Examination score < 19
  • Severe dyskinesia or severe on-off phenomenon
  • Plan to adjust medication at the time of screening
  • Other brain diseases such as stroke, brain tumor, etc
  • History of seizure
  • Vestibular disease or paroxysmal vertigo
  • Other comorbidities that make it difficult to participate in this study

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual reality exergames

Arm Description

Cognitively challenging exergames using fully immersive virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)

Outcomes

Primary Outcome Measures

Cognitive dual-task interference (%) in Timed-up & go test
Physical dual-task interference (%) in Timed-up & go test

Secondary Outcome Measures

Timed-up & go test (sec): single task
Timed-up & go test (sec): cognitive dual-task
Timed-up & go test (sec): physical dual-task
The Unified Parkinson's Disease Rating Scale
The higher the score, the more negative the result
Berg balance scale
The higher the score, the more positive the result
Stroop test
Trail making test
Digit span test
New Freezing of Gait Questionnaire (NFOGQ)

Full Information

First Posted
March 1, 2021
Last Updated
January 27, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04787549
Brief Title
Effect of Immersive Virtual Reality Exergames in Patients With Parkinson's Disease
Official Title
Effect of Cognitively Challenging Exergames Using Fully Immersive Virtual Reality in Patients With Parkinson's Disease: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
January 27, 2022 (Actual)
Study Completion Date
January 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aimed to investigate the effect of applying cognitively challenging exergames using fully immersive virtual reality in patients with Parkinson's disease.
Detailed Description
It has been reported that dual-task training involving both cognitive and physical functions helps improve walking speed during dual-task performance without increasing the fall risk in patients with Parkinson's disease (PD). Compared with conventional physical therapy, there are studies that dual-task training significantly improved walking speed and stride in PD patients. In addition, a systematic review study has been reported that it helps to improve balance and cognitive function when dual-task training is performed for patients with neurological diseases including Parkinson's disease. Virtual reality is expected to promote functional recovery in patients with neurological disorders in terms of providing an enriched environment, goal-directed tasks and repetition, and inducing interest and motivation. Therefore, the study aimed to investigate the effect of applying cognitively challenging exergames using fully immersive virtual reality in patients with PD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Virtual reality, Exergame

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality exergames
Arm Type
Experimental
Arm Description
Cognitively challenging exergames using fully immersive virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)
Intervention Type
Device
Intervention Name(s)
Virtual reality exergames
Intervention Description
A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for exergames using fully immersive virtual reality under the assistance of an occupational therapist.
Primary Outcome Measure Information:
Title
Cognitive dual-task interference (%) in Timed-up & go test
Time Frame
at study completion, an average of 1 month
Title
Physical dual-task interference (%) in Timed-up & go test
Time Frame
at study completion, an average of 1 month
Secondary Outcome Measure Information:
Title
Timed-up & go test (sec): single task
Time Frame
at study completion, an average of 1 month
Title
Timed-up & go test (sec): cognitive dual-task
Time Frame
at study completion, an average of 1 month
Title
Timed-up & go test (sec): physical dual-task
Time Frame
at study completion, an average of 1 month
Title
The Unified Parkinson's Disease Rating Scale
Description
The higher the score, the more negative the result
Time Frame
at study completion, an average of 1 month
Title
Berg balance scale
Description
The higher the score, the more positive the result
Time Frame
at study completion, an average of 1 month
Title
Stroop test
Time Frame
at study completion, an average of 1 month
Title
Trail making test
Time Frame
at study completion, an average of 1 month
Title
Digit span test
Time Frame
at study completion, an average of 1 month
Title
New Freezing of Gait Questionnaire (NFOGQ)
Time Frame
at study completion, an average of 1 month
Other Pre-specified Outcome Measures:
Title
Simulator sickness questionnaire (SSQ)
Time Frame
at 1st session (an average of 3 days) and at study completion (an average of 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed as idiopathic Parkinson's disease Modified Hoehn & Yahr stage 2, 2.5, or 3 Exclusion Criteria: Moderate to severe cognitive dysfunction with Mini-mental State Examination score < 19 Severe dyskinesia or severe on-off phenomenon Plan to adjust medication at the time of screening Other brain diseases such as stroke, brain tumor, etc History of seizure Vestibular disease or paroxysmal vertigo Other comorbidities that make it difficult to participate in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Gil Seo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Immersive Virtual Reality Exergames in Patients With Parkinson's Disease

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