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 |
Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device
Changes in QOL when communicative patients with ALS are trained to input text using a gaze input device
Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device
Changes in QOL when communicative patients with amyotrophic lateral sclerosis are trained to input text using a gaze input device
Japan |
Amyotrophic Lateral Sclerosis
Neurology |
Others
NO
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.
Efficacy
Exploratory
Explanatory
Phase II
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.
Subjective evaluation(VAS) of satisfaction and sense of accomplishment using gaze input device.
Changes in character input speed of gaze input character device.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Educational,Counseling,Training
Device,equipment |
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.
18 | years-old | < |
Not applicable |
Male and Female
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.
Patients who cannot input Romaji using a keyboard
13
1st name | NOBORU |
Middle name | |
Last name | SAITOU |
Dokkyo Medical University Saitama Medical Center
Comprehensive patient support center
343-8555
2-1-50 Minamikoshigaya, Koshigaya City, Saitama Prefecture
048-965-1111
shiroto@dokkyomed.ac.jp
1st name | HIROTO |
Middle name | |
Last name | SHIMIZU |
Dokkyo Medical University Saitama Medical Center
Comprehensive patient support center
343-8555
2-1-50 Minamikoshigaya, Koshigaya City, Saitama Prefecture
048-965-1111
shiroto@dokkyomed.ac.jp
Dokkyo Medical University Saitama Medical Center
HIROTO SHIMIZU
Dokkyo Medical University Saitama Medical Center
Self funding
Dokkyo Medical University Saitama Medical Center
2-1-50 Minamikoshigaya, Koshigaya City, Saitama Prefecture
048-965-0658
k-shien@dokkyomed.ac.jp
NO
獨協医科大学埼玉医療センター(埼玉県)
2024 | Year | 07 | Month | 23 | Day |
Unpublished
Enrolling by invitation
2024 | Year | 04 | Month | 01 | Day |
2024 | Year | 01 | Month | 24 | Day |
2024 | Year | 04 | Month | 01 | Day |
2024 | Year | 12 | Month | 31 | Day |
2024 | Year | 07 | Month | 23 | Day |
2024 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061483
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |