UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055051 |
|---|---|
| Receipt number | R000061483 |
| Scientific Title | Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device |
| Date of disclosure of the study information | 2024/07/23 |
| Last modified on | 2024/07/23 15:06:07 |
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Basic information
Public title
Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device
Acronym
Changes in QOL when communicative patients with ALS are trained to input text using a gaze input device
Scientific Title
Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device
Scientific Title:Acronym
Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device
Region
| Japan |
Condition
Condition
Amyotrophic Lateral Sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate patients' objective evaluation of the introduction of the communication tool by practicing the communication tool five times with ALS patients who are able to communicate, and observing their psychological changes and text input speed over time.
Regarding character input practice, based on previous research by Aoki et al., which showed that students can improve by practicing around 600 characters (Aoki, 2005), we decided to practice 200 characters at a time five times. Examine each practice session to monitor progress and psychological changes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Subjective QOL evaluation (ALSAQ-40) of ALS patients will be conducted after character input training.Conducted every time after the completion of training, which is held once a month.
Key secondary outcomes
Subjective evaluation(VAS) of satisfaction and sense of accomplishment using gaze input device.
Changes in character input speed of gaze input character device.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
1) Guide to the room where the training program will be conducted 2) Sit in front of a computer equipped with a gaze input device 3) Keep the distance between the patient's eyes and the computer screen 45 to 90 cm 4) Set up the equipment as follows: Carry out calibration by following the moving dots on the screen with your eyes. 5) Launch the document creation software and display the virtual keyboard on the screen. 6) Enter characters using the virtual keyboard. The subject of eye input training is Andersen's A total of 200 characters of excerpts from fairy tales will be used. Training time will end as soon as 200 characters have been entered, but the maximum training time will be 60 minutes.
Interventions/Control_2
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
Patients over 18 years old.Patients who have been diagnosed with ALS or suspected ALS.Patients currently attending a neurology clinic.Patients whose medical condition has been determined by the attending neurologist to be eligible for a total of 5 intervention programs.Patients who wish to use a communication tool and can provide written consent.Can maintain independent sitting position for about 1 hour.Patients who can operate digital devices such as computers or smartphones.Patients who can communicate by text or voice.Patients without cognitive impairment (MMSE 23 points or higher or HDS-R 15 points or higher).Patients who can get cooperation from family etc.
Key exclusion criteria
Patients who cannot input Romaji using a keyboard
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | NOBORU |
| Middle name | |
| Last name | SAITOU |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Comprehensive patient support center
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya City, Saitama Prefecture
TEL
048-965-1111
shiroto@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | HIROTO |
| Middle name | |
| Last name | SHIMIZU |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Comprehensive patient support center
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya City, Saitama Prefecture
TEL
048-965-1111
Homepage URL
shiroto@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
HIROTO SHIMIZU
Funding Source
Organization
Dokkyo Medical University Saitama Medical Center
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
Dokkyo Medical University Saitama Medical Center
Address
2-1-50 Minamikoshigaya, Koshigaya City, Saitama Prefecture
Tel
048-965-0658
k-shien@dokkyomed.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
獨協医科大学埼玉医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061483
