UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062413 |
|---|---|
| Receipt number | R000071422 |
| Scientific Title | Acquisition of communication means using an eye-gaze input device in two children with severe physical disabilities ineligible for public subsidy of communication aids: A single-case experimental design |
| Date of disclosure of the study information | 2026/08/15 |
| Last modified on | 2026/07/30 18:02:49 |
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Basic information
Public title
A study on communication support using an eye-gaze input device for children with severe physical disabilities
Acronym
Gaze-Communication Support Study
Scientific Title
Acquisition of communication means using an eye-gaze input device in two children with severe physical disabilities ineligible for public subsidy of communication aids: A single-case experimental design
Scientific Title:Acronym
Gaze-Communication SCED Study
Region
| Japan |
Condition
Condition
Severe physical disability (regardless of underlying etiology)
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify, using a single-case experimental design, the effect of support for acquiring communication means using an eye-gaze input device, provided to two children with severe physical disabilities whose experience in using such devices and opportunities to learn them are limited because they are ineligible for the public subsidy system for communication aids for persons with severe disabilities (Assistive Device Subsidy System).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Goal Attainment Scaling (GAS) scores (5-point scale, -2 to +2) rating the degree of attainment of three target behaviors of eye-gaze-based communication (Task 1: conversational context; Task 2: situational context; Task 3: emotional context). GAS is measured at every session, and its trajectory across the baseline, intervention, and follow-up phases is evaluated by visual analysis and effect size (Tau-U).
Key secondary outcomes
Performance and satisfaction scores of the Canadian Occupational Performance Measure (COPM), and their change scores, administered to each participant's guardian at three time points: early baseline, immediately after the intervention phase, and late follow-up (3 months after the end of the intervention).
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
| Behavior,custom |
Interventions/Control_1
Using an eye-gaze input device and communication software (fixed phrases arranged in a 12-16 cell layout), the intervention supports the child's expression of intentions during routine daily care sessions at an after-school day-service facility. Based on a multiple-baseline design across behaviors, the intervention is introduced in a staggered manner to three target behaviors (Task 1: yes/no responses to questions; Task 2: greetings/expressions of thanks; Task 3: expressing impressions/feedback), with intensive practice given to only the one behavior currently in its intervention phase while the others remain without practice until they enter their own intervention phase. Each session lasts about 20-30 minutes excluding device setup, and each behavior's intervention phase is capped at roughly 10 sessions. No intervention is provided during the baseline phase (at least 5 sessions) or the 3-month follow-up phase (5 sessions per month). The total study period is expected to be about 6 months.
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All of the following must be met:
(1) The child is generally judged to be ineligible for subsidy under the public subsidy system for assistive devices (communication aids for persons with severe disabilities) by a certified assistive-technology adviser well versed in communication devices.
(2) Due to severe physical disability, the child has difficulty communicating through bodily movements such as speech or writing.
(3) The child is judged to retain a certain level of visual function and of arousal/attention necessary to operate an eye-gaze input device.
(4) The child continuously attends the after-school day-service facility serving as the study site, and participation throughout the study period is anticipated.
(5) Written consent for study participation is obtained from the proxy consenter (guardian).
Key exclusion criteria
Cases in which continued study participation is judged to place a physical or psychological burden on the child, such as unstable physical condition.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Sakai |
Organization
Ota College of Medical Technology
Division name
University Establishment Preparation Office
Zip code
373-0812
Address
1373 Higashinagaoka-cho, Ota-shi, Gunma, Japan
TEL
0276-25-2414
s-sakai@ojs.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Sakai |
Organization
Ota College of Medical Technology
Division name
University Establishment Preparation Office
Zip code
373-0812
Address
1373 Higashinagaoka-cho, Ota-shi, Gunma, Japan
TEL
0276-25-2414
Homepage URL
s-sakai@ojs.ac.jp
Sponsor or person
Institute
iCare Hokkaido, Specified Nonprofit Corporation
Institute
Department
Personal name
Funding Source
Organization
The Nippon Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Healthcare University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ota College of Medical Technology Research Ethics Committee
Address
1373 Higashinagaoka-cho, Ota-shi, Gunma, Japan
Tel
0276-25-2414
omt-post@ojs.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
放課後デイばおばぶ（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071422
