UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049144 |
|---|---|
| Receipt number | R000055981 |
| Scientific Title | Clinical trial on the effectiveness and feasibility of a VR table tennis program in people with Parkinson disease |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/10/08 10:21:20 |
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Basic information
Public title
Clinical trial to verify effectiveness of VR table tennis program for people with Parkinson disease
Acronym
Clinical trial of VR table tennis program for Parkinson disease
Scientific Title
Clinical trial on the effectiveness and feasibility of a VR table tennis program in people with Parkinson disease
Scientific Title:Acronym
Clinical trials on 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
Prospective evaluation of the effectiveness of VR table tennis rehabilitation for patients with Parkinson disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
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. 3m up & go test
6. 10m gait
7. Parkinson's Disease Questionnaire
8. System Usability Scale
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rehabilitation combining VR table tennis rehabilitation with occupational and speech therapies is provided to study participants. The VR model and software used for the study is the Oculus Quest 2 and the Eleven Table Tennis software provided by Meta Platforms. A practice mode is used in which participants rally against a game opponent on a virtual table tennis table, and a match mode in which they fight against an opponent. First, the patient performs preparatory exercises (neck stretching, upper limb stretching, lower limb stretching, lateral stepping and swinging (fore-back-switching)) for five minutes, followed by 15 min in practice mode; after five minutes break, the patient trains in match mode for 15 minutes. During training in match mode, breaks should be taken at the patient's request or at the discretion of the assisting healthcare professional. Patients at risk of falling due to balance problems can perform the program in a sitting position. After training with VR table tennis program, 40-minute occupational therapy and 40-minute speech therapy are given. If, during the training, it becomes difficult to continue for more than 25 minutes due to fatigue or off state, the results of the session will not be included in the data. The study duration is two months. Frequency of implementation is twice a week.
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. People who fulfil the clinical diagnostic criteria as Probable Parkinson disease
2. People with Parkinson disease with severity of Hohen & Yahr I-III
3. Any gender
Key exclusion criteria
1. People with Parkinsonian syndrome other than Parkinson disease
2. People with cognitive impairment (MoCA-J less than 20 points)
3. People with suffering from inner ear disorders that may cause VR sickness
4. People who have difficulty continuing VR for more than 10 minutes due to VR sickness during the VR experience conducted beforehand
5. People who have regularly played table tennis within 3 months before study participation
6. People who are deemed unsuitable by the principal investigator or a sub-investigator
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Murakami Karindoh Hospital
Division name
Neurology
Zip code
819-8585
Address
2-14-45, Togire, Nishi-ku, Fukuoka, Japan
TEL
092-811-3331
shinsuke@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Fujioka |
Organization
Murakami Karindoh Hospital
Division name
Neurology
Zip code
819-8585
Address
2-14-45, Togire, Nishi-ku, Fukuoka, Japan
TEL
092-811-3331
Homepage URL
shinsuke@cis.fukuoka-u.ac.jp
Sponsor or person
Institute
Murakami Karindoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Murakami Karindoh Hospital
Address
2-14-45, Togire, Nishi-ku, Fukuoka, Japan
Tel
092-811-3331
kitano.k@karindoh.or.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
| 2022 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055981
