UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061872 |
|---|---|
| Receipt number | R000070796 |
| Scientific Title | An Evaluation of the Initial Efficacy of a One-Handed Game Controller: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/11 15:44:10 |
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Basic information
Public title
An Evaluation of the Initial Efficacy of a One-Handed Game Controller: A Randomized Crossover Trial
Acronym
An Evaluation of the Initial Efficacy of a One-Handed Game Controller: A Randomized Crossover Trial
Scientific Title
An Evaluation of the Initial Efficacy of a One-Handed Game Controller: A Randomized Crossover Trial
Scientific Title:Acronym
An Evaluation of the Initial Efficacy of a One-Handed Game Controller: A Randomized Crossover Trial
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to conduct an exploratory evaluation of the device's feasibility and initial efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time taken to complete the self-made game evaluation assignment
Key secondary outcomes
Japanese Version of the System Usability Scale
Japanese Version of the Game Engagement Questionnaire
User Experience Questionnaire (Likert scale)
The User Experience Questionnaire consists of sections on enjoyment, fatigue, intention to continue using the product, purchase intention (whether the respondent wishes to purchase the product and their acceptable price), device malfunctions, and open-ended comments.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Conduct an evaluation of a custom-made game using the one-handed game controller developed in this study
Interventions/Control_2
Conducting a self-designed game evaluation task using an existing one-handed game grip
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have experienced a first stroke and exhibit symptoms on only one side (regardless of symptom severity)
2) Patients capable of operating this device or an existing single-hand game controller with either their left or right upper limb
3) Patients who can maintain a seated position independently, or who can safely maintain a seated position in their usual chair or wheelchair
Key exclusion criteria
1)Individuals with impaired cognitive function (MMSE score of 23 or lower)
2)Individuals who have difficulty understanding or performing game tasks or answering questionnaires due to higher-level cognitive impairments such as severe visual or hearing impairments, aphasia, or attention disorders
3)Individuals deemed unable to participate safely due to pain, fatigue, dizziness, blood pressure fluctuations, or poor general health
4)Individuals for whom game operation is deemed inappropriate due to upper limb immobilization or weight-bearing restrictions, postoperative contraindications, or activity restrictions prescribed by a physician
5)Individuals from whom informed consent for the study cannot be obtained
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Moe |
| Middle name | |
| Last name | Fujita |
Organization
Sonoda-kai Neuro-Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
120-0012
Address
1-10-10 Aoi, Adachi Ward, Tokyo
TEL
03-5845-0126
araimmm.0201@gmail.com
Public contact
Name of contact person
| 1st name | Moe |
| Middle name | |
| Last name | Fujita |
Organization
Sonoda-kai Neuro-Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
123-0012
Address
1-10-10 Aoi, Adachi Ward, Tokyo
TEL
03-5845-0126
Homepage URL
araimmm.0201@gmail.com
Sponsor or person
Institute
Sonoda-kai Neuro-Rehabilitation Hospital
Institute
Department
Personal name
Moe Fujita
Funding Source
Organization
Sonoda-kai Neuro-Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sonodakai Medical Corporation
Address
3-4-10 Hokima, Adachi Ward, Tokyo
Tel
03-5851-7551
irb@sonodakai.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
苑田会ニューロリハビリテーション病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | 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
| 2026 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070796
