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

January 27, 2022 updated by: Han Gil Seo, Seoul National University Hospital

Effect of Cognitively Challenging Exergames Using Fully Immersive Virtual Reality in Patients With Parkinson's Disease: A Pilot Study

The study aimed to investigate the effect of applying cognitively challenging exergames using fully immersive virtual reality in patients with Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

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 Locations

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality exergames
Cognitively challenging exergames using fully immersive virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan)
Device: Virtual reality exergames
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive dual-task interference (%) in Timed-up & go test
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
Physical dual-task interference (%) in Timed-up & go test
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed-up & go test (sec): single task
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
Timed-up & go test (sec): cognitive dual-task
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
Timed-up & go test (sec): physical dual-task
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
The Unified Parkinson's Disease Rating Scale
Time Frame: at study completion, an average of 1 month
The higher the score, the more negative the result
at study completion, an average of 1 month
Berg balance scale
Time Frame: at study completion, an average of 1 month
The higher the score, the more positive the result
at study completion, an average of 1 month
Stroop test
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
Trail making test
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
Digit span test
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month
New Freezing of Gait Questionnaire (NFOGQ)
Time Frame: at study completion, an average of 1 month
at study completion, an average of 1 month

Other Outcome Measures

Outcome Measure
Time Frame
Simulator sickness questionnaire (SSQ)
Time Frame: at 1st session (an average of 3 days) and at study completion (an average of 1 month)
at 1st session (an average of 3 days) and at study completion (an average of 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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)

July 20, 2021

Primary Completion (Actual)

January 27, 2022

Study Completion (Actual)

January 27, 2022

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-VR-pilot

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.

Clinical Trials on Parkinson Disease

Clinical Trials on Virtual reality exergames

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe