UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050937 |
|---|---|
| Receipt number | R000055219 |
| Scientific Title | Randomized control trial investigating the effectiveness and feasibility of VR table tennis program for Parkinson disease |
| Date of disclosure of the study information | 2023/04/26 |
| Last modified on | 2023/04/26 16:47:33 |
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Basic information
Public title
Randomized control trial investigating the effectiveness and feasibility of VR table tennis program for Parkinson disease
Acronym
Clinical trial on VR table tennis program for Parkinson's disease
Scientific Title
Randomized control trial investigating the effectiveness and feasibility of VR table tennis program for Parkinson disease
Scientific Title:Acronym
Clinical trial investigating the effectiveness and feasibility of VR table tennis program for Parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the effectiveness of VR table tennis rehabilitation for patients with Parkinson's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MDS-UPDRS part III
Key secondary outcomes
1.MDS-UPDRS part I, II, IV
2.Montreal Cognitive Assessment
3.Self rating Depression Scale
4.Apathy Evaluation Scale
5.10m gait
6.Functional Independence Measure
7.Balance evaluation using a center of gravity sway meter
8.Parkinson's Disease Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
VR ping pong group
Interventions/Control_2
Control rehabilitation group
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who meet the clinical diagnostic criteria for probable Parkinson disease
2. Patients with Hohen & Yahr I, II, and III
3. Patients who go to our hospital for rehabilitation
4. Any gender
Key exclusion criteria
1. Patients who is diagnosed as Parkinsonian syndrome other than Parkinson disease
2. Patients with cognitive impairment
3. Patients with inner ear disorders that may cause VR sickness
4. Patients who have difficulty continuing VR for more than 10 minutes due to VR sickness during the VR experience conducted beforehand
5. Patients who have played table tennis regularly within 3 months of participation in the study
6. Patients who are deemed to be inappropriate by the principal investigator or sub-investigators of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Tsuboi |
Organization
Fukuoka University
Division name
Department of Neurology
Zip code
8140180
Address
7-45-1, Nanakuma, Jona-ku, Fukuoka, Fukuoka, Japan
TEL
092-801-1011
tsuboi@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Fukuoka University
Division name
Department of Neurology
Zip code
8140180
Address
7-45-1, Nanakuma, Jona-ku, Fukuoka, Fukuoka, Japan
TEL
092-801-1011
Homepage URL
shinsuke@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Murakami Karindoh Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University
Address
7-45-1, Nanakuma, Jona-ku, Fukuoka, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-u.ac.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
| 2023 | Year | 04 | Month | 26 | 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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055219
