UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057562 |
|---|---|
| Receipt number | R000065773 |
| Scientific Title | International multi-center randomized control trial to investigate efficacy of VR ping-pong rehabilitation therapy for Parkinson disease patients |
| Date of disclosure of the study information | 2025/04/14 |
| Last modified on | 2025/04/09 13:29:07 |
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Basic information
Public title
International multi-center randomized control trial to investigate efficacy of VR ping-pong rehabilitation therapy for Parkinson disease patients
Acronym
International multi-center randomized control trial to investigate efficacy of VR ping-pong rehabilitation therapy for Parkinson disease patients
Scientific Title
International multi-center randomized control trial to investigate efficacy of VR ping-pong rehabilitation therapy for Parkinson disease patients
Scientific Title:Acronym
International multi-center randomized control trial of VR ping-pong rehabilitation therapy for Parkinson disease patients
Region
| Japan | Asia(except Japan) |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A clinical trial to evaluate whether rehabilitation using virtual reality (VR) table tennis software can improve motor and non-motor symptoms in patients with Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MDS-UPDRS part III score
Key secondary outcomes
Evaluation of non-motor symptoms: MDS-UPDRS Part I score
Evaluation of ADL: MDS-UPDRS Part II score
Evaluation of motor complications: MDS-UPDRS Part IV score
Evaluation of QOL: Parkinson's Disease Questionnaire (PDQ-8)
TUG (Timed Up and Go Test)
Presence or absence of VR sickness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We provide participants with VR ping pong rehabilitation and also educational newsletters.
Interventions/Control_2
We provide participents with only educational newsletters.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with Parkinson disease who visit each study site between April 1, 2025, and December 31, 2025.
Patients who can provide written informed consent to participate in the study of their own free will.
Patients aged between 30 and 80 years at the time of consent.
Outpatient status: Limited to outpatients.
Key exclusion criteria
Patients with cognitive impairment
Patients classified as stage IV or higher according to the Hoehn & Yahr scale for Parkinson disease
Patients receiving device-assisted therapy for Parkinson disease
Patients with orthopedic conditions such as arthritis or spinal disorders
Patients with a history of stroke or peripheral nerve and muscle diseases
Patients with significant vision or hearing impairments that prevent the use of a VR headset
Patients deemed by the researcher to be at high risk of falling during VR based table tennis exercises
Patients who have previously experienced motion sickness symptoms when using VR devices
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Takagi Hospital
Division name
Department of Neurology
Zip code
831-0016
Address
141-11, Sakemi, Okawa, Fukuoka, Japan
TEL
(0944)87-0001
s.fujioka@ihwg.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Takagi Hospital
Division name
Department of Neurology
Zip code
831-0016
Address
141-11, Sakemi, Okawa, Fukuoka, Japan
TEL
(0944)87-0001
Homepage URL
s.fujioka@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
137-1, Enokizu, Okawa, Fukuoka, Japan
Tel
0944-89-2000
s.fujioka@ihwg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065773
