UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057847 |
|---|---|
| Receipt number | R000066103 |
| Scientific Title | Development and Evaluation of an Assistive Device for One-Handed Joy-Con Operation |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/10 18:39:15 |
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Basic information
Public title
A Study on the Usability of a Controller Aid for Enjoying Games with One Hand
Acronym
One-Hand Game Aid Study
Scientific Title
Development and Evaluation of an Assistive Device for One-Handed Joy-Con Operation
Scientific Title:Acronym
Joy-Con Assist Device Trial
Region
| Japan |
Condition
Condition
Upper limb functional impairment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of an assistive device designed to enable individuals with use of only one upper limb to operate both Joy-Cons with one hand.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An index calculated by dividing the average time required to perform designated operations (button presses, stick tilts) displayed on a PC screen by the accuracy rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Using the developed one-handed Joy-Con assistive device (prototype), participants will perform corresponding operations with one hand in response to 34 types of operation instructions displayed on a PC screen. Reaction time and accuracy will be recorded to quantitatively evaluate operational immediacy and precision. Each participant will undergo up to 10 practice trials, followed by 3 main trials. Subjective evaluations will also be collected using Likert scales and open-ended questionnaires.
Interventions/Control_2
Using a commercially available one-handed Joy-Con assistive device (off-the-shelf product), participants will perform corresponding operations with one hand in response to 34 types of operation instructions displayed on a PC screen. Reaction time and accuracy will be recorded to quantitatively evaluate operational immediacy and precision. Each participant will undergo up to 10 practice trials followed by 3 main trials. Subjective evaluations will also be collected using Likert scales and open-ended questionnaires.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older
Enrolled students at Hokkaido University of Science
No functional impairment in the dominant (right) hand
Able to understand the purpose and procedures of the study and provide written informed consent
Key exclusion criteria
Individuals with systemic infections requiring medical treatment
Individuals with a body temperature of 37.0C or higher at the time of registration
Individuals with upper limb injuries, pain, or inflammation that may interfere with operation
Individuals who are judged to have difficulty understanding the study procedures or providing voluntary informed consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsuruga |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics, Faculty of Health Sciences
Zip code
006-8585
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
011-688-2235
tsuruga@hus.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsuruga |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics, Faculty of Health Sciences
Zip code
006-8585
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
TEL
011-688-2235
Homepage URL
tsuruga@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University of Science
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
Hokkaido University of Science Ethics Committee
Address
7-Jo 15-4-1 Maeda, Teine, Sapporo, Hokkaido, Japan
Tel
011-688-2241
kenkyu@hus.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
| 2025 | Year | 05 | 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 | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 06 | 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
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066103
