Clinical trial NCT04787549: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Virtual reality
Exergame
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Cognitive dual-task interference (%) in Timed-up & go test
timeFrame: at study completion, an average of 1 month
measure: Physical dual-task interference (%) in Timed-up & go test
timeFrame: at study completion, an average of 1 month
Secondary outcomes:
measure: Timed-up & go test (sec): single task
timeFrame: at study completion, an average of 1 month
measure: Timed-up & go test (sec): cognitive dual-task
timeFrame: at study completion, an average of 1 month
measure: Timed-up & go test (sec): physical dual-task
timeFrame: at study completion, an average of 1 month
measure: The Unified Parkinson's Disease Rating Scale
timeFrame: at study completion, an average of 1 month
measure: Berg balance scale
timeFrame: at study completion, an average of 1 month
measure: Stroop test
timeFrame: at study completion, an average of 1 month
measure: Trail making test
timeFrame: at study completion, an average of 1 month
measure: Digit span test
timeFrame: at study completion, an average of 1 month
measure: New Freezing of Gait Questionnaire (NFOGQ)
timeFrame: at study completion, an average of 1 month
Other outcomes:
measure: Simulator sickness questionnaire (SSQ)
timeFrame: at 1st session (an average of 3 days) and at study completion (an average of 1 month)
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han Gil Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: