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Completed

NCT Number: NCT04787549

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality exergames

Device

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 outcomes

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

    Time frame: at study completion, an average of 1 month

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

    Time frame: at study completion, an average of 1 month

Secondary outcomes

  1. Timed-up & go test (sec): single task

    Time frame: at study completion, an average of 1 month

  2. Timed-up & go test (sec): cognitive dual-task

    Time frame: at study completion, an average of 1 month

  3. Timed-up & go test (sec): physical dual-task

    Time frame: at study completion, an average of 1 month

  4. 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

  5. Berg balance scale

    Time frame: at study completion, an average of 1 month

    The higher the score, the more positive the result

  6. Stroop test

    Time frame: at study completion, an average of 1 month

  7. Trail making test

    Time frame: at study completion, an average of 1 month

  8. Digit span test

    Time frame: at study completion, an average of 1 month

  9. New Freezing of Gait Questionnaire (NFOGQ)

    Time frame: at study completion, an average of 1 month

Other outcomes

  1. Simulator sickness questionnaire (SSQ)

    Time frame: at 1st session (an average of 3 days) and at study completion (an average of 1 month)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2021
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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