Parkinson DiseaseNCT04787549
Effect of Immersive Virtual Reality Exergames in Patients With Parkinson's Disease
A study testing Virtual reality exergames in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Virtual reality exergames
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2021to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed as idiopathic Parkinson's disease
- Modified Hoehn \& Yahr stage 2, 2.5, or 3
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Virtual reality exergames
- Keywords
- Parkinson's disease, Virtual reality, Exergame
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Virtual reality exergames |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive dual-task interference (%) in Timed-up & go test
Measured: at study completion, an average of 1 month
Physical dual-task interference (%) in Timed-up & go test
Measured: at study completion, an average of 1 month
Secondary outcomes (9)
Timed-up & go test (sec): single task
Measured: at study completion, an average of 1 month
Timed-up & go test (sec): cognitive dual-task
Measured: at study completion, an average of 1 month
Timed-up & go test (sec): physical dual-task
Measured: at study completion, an average of 1 month
The Unified Parkinson's Disease Rating Scale
The higher the score, the more negative the result
Measured: at study completion, an average of 1 month
Berg balance scale
The higher the score, the more positive the result
Measured: at study completion, an average of 1 month
Stroop test
Measured: at study completion, an average of 1 month
Trail making test
Measured: at study completion, an average of 1 month
Digit span test
Measured: at study completion, an average of 1 month
New Freezing of Gait Questionnaire (NFOGQ)
Measured: at study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start20 Jul 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Gil Seo, Seoul National University Hospital
- Investigators
- Han Gil Seo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787549
- Sponsor's protocol ID
- PD-VR-pilot
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37464349
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cognitively Challenging Exergames Using Fully Immersive Virtual Reality in Patients With Parkinson's Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT04787549
- Acronym / sponsor ID
- PD-VR-pilot
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Virtual reality, Exergame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality exergames | Experimental | Device: Virtual reality exergamesCognitively challenging exergames using fully immersive virtual reality with a head-mounted display (HTC Vive; HTC Co., New Taipei City, Taiwan) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed as idiopathic Parkinson's disease
- Modified Hoehn \& Yahr stage 2, 2.5, or 3
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality exergamesA 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. | Device | Virtual reality exergames |
Primary outcome
Cognitive dual-task interference (%) in Timed-up & go test
Time frame: 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
9 secondary outcomes
Timed-up & go test (sec): single task
Time frame: 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
Timed-up & go test (sec): physical dual-task
Time frame: 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
Berg balance scale
Time frame: at study completion, an average of 1 month
Stroop test
Time frame: at study completion, an average of 1 month
Trail making test
Time frame: at study completion, an average of 1 month
Digit span test
Time frame: at study completion, an average of 1 month
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: at study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Derived from this study: PubMed 37464349Yun 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Gil Seo, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality exergames in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive dual-task interference (%) in Timed-up & go test (time frame: at study completion, an average of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.