UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031315
Receipt number 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 09:22:05

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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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Value
https://center6.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