UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033366
Receipt number R000038038
Scientific Title Preliminary study to evaluate efficacy of a sight-based character input device for entering characters into a personal computer for patients with neuromuscular disease
Date of disclosure of the study information 2018/07/11
Last modified on 2022/03/22 14:35:02

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Basic information

Public title

Preliminary study to evaluate efficacy of a sight-based character input device for entering characters into a personal computer for patients with neuromuscular disease

Acronym

Preliminary study to evaluate efficacy of a sight-based character input device for entering characters into a personal computer for patients with neuromuscular disease

Scientific Title

Preliminary study to evaluate efficacy of a sight-based character input device for entering characters into a personal computer for patients with neuromuscular disease

Scientific Title:Acronym

Preliminary study to evaluate efficacy of a sight-based character input device for entering characters into a personal computer for patients with neuromuscular disease

Region

Japan


Condition

Condition

Neuromuscular disease

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of a sight-based character input device for patients with severe movement disorders due to neuromuscular diseases.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Subjective degree of ease of use

Key secondary outcomes

Number of input characters, number of incorrect input characters, 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

The character input task is implemented twice for 3 minutes using the test device (the sight-based input device).
After this task, a questionnaire-based survey regarding fatigue and ease of use of the device is conducted.

Interventions/Control_2

The same task using a control device (a device that is regularly used) also is implemented on another day.
We plan to conduct a questionnaire survey to determine which device is easier to use.
Which device is tested first is randomly selected. After using both devices,

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

Patients who present with movement disorders due to neuromuscular diseases, such as amyotrophic lateral sclerosis or muscular dystrophy.
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

10


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

Address

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)


Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 11 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

7

Results

Seven patients with muscular dystrophy were asked to input text into a computer using either the usual method or eye-tracking. It was suggested that a gaze input device may be effective in cases where the user is unable to satisfactorily input text using the usual method or when there is a great deal of physical strain.

Results date posted

2022 Year 03 Month 22 Day

Results Delayed

Delay expected

Results Delay Reason

Paper not accepted for publication

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 07 Month 03 Day

Date of IRB

2018 Year 07 Month 03 Day

Anticipated trial start date

2018 Year 07 Month 18 Day

Last follow-up date

2019 Year 01 Month 23 Day

Date of closure to data entry

2019 Year 01 Month 23 Day

Date trial data considered complete

2019 Year 01 Month 23 Day

Date analysis concluded

2020 Year 01 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 07 Month 11 Day

Last modified on

2022 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name