Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062413) titled 'A study on communication support using an eye-gaze input device for children with severe physical disabilities' on Aug. 15.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - iCare Hokkaido, Specified Nonprofit Corporation

Condition: Condition - Severe physical disability (regardless of underlying etiology) Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 6 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 Size - 2

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 31 Day Anticipated trial start date - 2026 Year 08 Month 24 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071422

Disclaimer: Curated by HT Syndication.