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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033366
Receipt No. R000038038
Official scientific title of the study 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 2018/07/11

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Basic information
Official scientific title of the study Preliminary study to evaluate efficacy of a sight-based character input device for entering characters into a personal computer for patients with neuromuscular disease
Title of the study (Brief 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
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 Hitoshi Mutai
Organization Shinshu University
Division name Division of occupational therapy, School of health sciences, Faculty of Medicine
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2405
Email hitmutai@shinshu-u.ac.jp

Public contact
Name of contact person Masato Nakagawa
Organization Misayama Hospital
Division name Department of occupational therapy
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 03 Day
Anticipated trial start date
2018 Year 07 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 11 Day
Last modified on
2018 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.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


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