UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048690 |
|---|---|
| Receipt number | R000055351 |
| Scientific Title | Examination of the accuracy and simplicity of communication caused by the difference in the type of transparent communication boards for ALS patients and caregivers |
| Date of disclosure of the study information | 2022/08/18 |
| Last modified on | 2023/01/06 13:53:58 |
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Basic information
Public title
Examination of the accuracy and simplicity of communication caused by the difference in the type of transparent communication boards for ALS patients and caregivers
Acronym
Examination of the accuracy and simplicity of communication caused by the difference in the type of transparent communication boards for ALS patients and caregivers
Scientific Title
Examination of the accuracy and simplicity of communication caused by the difference in the type of transparent communication boards for ALS patients and caregivers
Scientific Title:Acronym
Examination of the accuracy and simplicity of communication caused by the difference in the type of transparent communication boards for ALS patients and caregivers
Region
| Japan |
Condition
Condition
amyotrophic lateral sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the accuracy and simplicity of use of different types of transparent communication boards, which are most commonly used by ALS patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of the number of mistakes between different transparent communication boards (number of mistakes in all 18 characters)
Key secondary outcomes
Percentage of the number of mistakes between different transparent communication boards(number of mistakes per word)
Reading time between different transparent communication boards(time to finish reading 3 words, lap time per word is measured)
Questionnaire values between different transparent communication boards
Japanese POMS2 values between different transparent communication boards
Comparison of the relationship between ALSFRS-R scores and the number of errors on the communication boards, reading time, and Japanese POMS2
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
(Japanese syllabary transparent communication boards-Flick type boards)
View the video in which the use of the boards is explained, and practice it of Japanese syllabary using the exercises.Then, they will be evaluated on three words. Then allow a washout period of at least one week, and have them do the same thing with a different flicking it than the previous one. (Practice and production tasks are different)
Interventions/Control_2
(Flick type transparent communication boards-Japanese syllabary boards)
View the video in which the use of the boards is explained, and practice it of flick type using the exercises.Then, they will be evaluated on three words. Then allow a washout period of at least one week, and have them do the same thing with a different Japanese syllabary it than the previous one. (Practice and production tasks are different)
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
Key Inclusion Criteria for "ALS Patients"
(1) Patients must have been diagnosed with ALS.
(2)The patient must be able to walk on his/her own or use a wheelchair.
(3)The patient must have never used a transparent communication boards.
(4)The patient must be at least 18 years of age at the time of written consent.
Key Inclusion Criteria for "Caregiver of ALS Patient"
(1)The applicant must be a caregiver of a patient diagnosed with ALS.
(2)The caregiver must be the person who has the most contact with ALS patients and communicates with them frequently.
(3)The ALS patient recognizes you as his/her caregiver.
(4)The caregiver has never used a transparent communication boards.
(5) The caregiver must be at least 18 years old at the time of written consent.
Key exclusion criteria
(1)Either the patient or the caregiver has used a transparent dial
(2)They are unable to understand Japanese explanations
(3)Difficulty in walking on his/her own or moving in a wheelchair and using a stretcher
(4)Patients deemed inappropriate by the person in charge of this study
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hisatomo |
| Middle name | |
| Last name | Kowa |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL
078-796-4561
kowa@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Sano |
Organization
Kobe University
Division name
Department of Rehabilitation Science, Graduate School of Health Sciences
Zip code
654-0142
Address
Room 109, 1st floor, Building F, Kobe University, 7-10-2 Tomogaoka, Suma-ku, Kobe City, Hyogo, Japan
TEL
080-6172-4196
Homepage URL
211k205k@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Science, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Okasan-Kato Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The neurology department at Kobe University Hospital
Department of Health Science, Graduate School of Medicine, Osaka University
Department of Neurology, Graduate School of Medicine, Mie University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research, Innovation and Education Center, Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe City, Hyogo, Japan
Tel
078-382-6669
kainyu@med.kobe-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
神戸大学医学部附属病院（兵庫県）
大阪大学医学部附属病院（大阪府）
アスト津 貸し会議室（三重県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 18 | 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
4
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
| 2022 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055351
