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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787549
• Other study ID #: PD-VR-pilot
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: January 27, 2022

Study information

• Verified date: January 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 27, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Simulator sickness questionnaire (SSQ)		at 1st session (an average of 3 days) and at study completion (an average of 1 month)
Primary	Cognitive dual-task interference (%) in Timed-up & go test		at study completion, an average of 1 month
Primary	Physical dual-task interference (%) in Timed-up & go test		at study completion, an average of 1 month
Secondary	Timed-up & go test (sec): single task		at study completion, an average of 1 month
Secondary	Timed-up & go test (sec): cognitive dual-task		at study completion, an average of 1 month
Secondary	Timed-up & go test (sec): physical dual-task		at study completion, an average of 1 month
Secondary	The Unified Parkinson's Disease Rating Scale	The higher the score, the more negative the result	at study completion, an average of 1 month
Secondary	Berg balance scale	The higher the score, the more positive the result	at study completion, an average of 1 month
Secondary	Stroop test		at study completion, an average of 1 month
Secondary	Trail making test		at study completion, an average of 1 month
Secondary	Digit span test		at study completion, an average of 1 month
Secondary	New Freezing of Gait Questionnaire (NFOGQ)		at study completion, an average of 1 month