NCT04787549

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

March 1, 2021

Last Update Submit

January 27, 2022

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseVirtual realityExergame

Outcome Measures

Primary Outcomes (2)

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

    at study completion, an average of 1 month

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

    at study completion, an average of 1 month

Secondary Outcomes (9)

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

    at study completion, an average of 1 month

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

    at study completion, an average of 1 month

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

    at study completion, an average of 1 month

  • The Unified Parkinson's Disease Rating Scale

    at study completion, an average of 1 month

  • Berg balance scale

    at study completion, an average of 1 month

  • +4 more secondary outcomes

Other Outcomes (1)

  • Simulator sickness questionnaire (SSQ)

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

Study Arms (1)

Virtual reality exergames

EXPERIMENTAL

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

Interventions

Virtual reality exergamesDEVICE

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.

Virtual reality exergames

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Yun SJ, Hyun SE, Oh BM, Seo HG. Fully immersive virtual reality exergames with dual-task components for patients with Parkinson's disease: a feasibility study. J Neuroeng Rehabil. 2023 Jul 18;20(1):92. doi: 10.1186/s12984-023-01215-7.

    PMID: 37464349DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Han Gil Seo, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 8, 2021

Study Start

July 20, 2021

Primary Completion

January 27, 2022

Study Completion

January 27, 2022

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

KR(1)