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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031315
Receipt No. R000035742
Scientific Title A comparative study of two types of line of sight input devices in the character input system of a personal computer
Date of disclosure of the study information 2018/02/15
Last modified on 2020/08/18

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Basic information
Public title A comparative study of two types of line of sight input devices in the character input system of a personal computer
Acronym A comparative study of two types of line of sight input devices in the character input system of a personal computer
Scientific Title A comparative study of two types of line of sight input devices in the character input system of a personal computer
Scientific Title:Acronym A comparative study of two types of line of sight input devices in the character input system of a personal computer
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate and compare the performance and efficacy of gaming and welfare devices with line of sight input devices in the character input system of personal computers for patients with severe movement disorders due to neuromuscular disorders and high level spinal cord injuries.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of input characters
Key secondary outcomes Number of incorrect input characters, subjective degree of ease of use, degree of fatigue

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Implement a character input task using the test device (game device) on the first day, and implement the task using the control device (welfare device) on the next day. The character input task is implemented twice for each line of sight input device.
Each time after inputting the characters, we conduct a questionnaire regarding fatigue and ease of use. After using both the devices, we conduct a questionnaire on which device was easier to use.
Interventions/Control_2 Implement a character input task using the control device (welfare device) on the first day, and implement the task using the test device (game device) on the next day. The character input task is implemented twice for each line of sight input device.
Each time after inputting the characters, we conduct a questionnaire regarding fatigue and ease of use. After using both the devices, we conduct a questionnaire on which device was easier to use.
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

Not applicable
Gender Male and Female
Key inclusion criteria The visual acuity (or orthodontic vision) is normal. The results are assessed by checking the facility belonging to the subject, possession of a driver's license, and examination of visual acuity by the researcher.
Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria People with ocular motility disorder who are unable to use line of sight input devices are excluded.
Additionally, people who have been diagnosed with dry eye, cataract, glaucoma, conjunctivitis, dysautonomia, and photophobic epilepsy are also excluded.
Patients who have otherwise been determined to be ineligible as a subject by the principal investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Mutai
Organization Shinshu University
Division name Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code 390-8621
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2405
Email hitmutai@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Nakagawa
Organization Misayama Hospital
Division name Department of occupational therapy
Zip code 386-0393
Address 1777, Kakeyuonsen, Ueda, Nagano, Japan
TEL 0268-44-2321
Homepage URL
Email misayama.ot@gmail.com

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
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 Shinshu University Medical ethics committee
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel 0263-37-2572
Email mdrinri@shinshu-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 三才山病院(長野県)Misayaa Hospital (Nagano),信州大学(長野県)Shinshu university (Nagano)

Other administrative information
Date of disclosure of the study information
2018 Year 02 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 Completed
Date of protocol fixation
2018 Year 02 Month 08 Day
Date of IRB
2018 Year 02 Month 08 Day
Anticipated trial start date
2018 Year 02 Month 19 Day
Last follow-up date
2018 Year 04 Month 13 Day
Date of closure to data entry
2018 Year 04 Month 20 Day
Date trial data considered complete
2019 Year 10 Month 29 Day
Date analysis concluded
2020 Year 01 Month 09 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 15 Day
Last modified on
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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