Applying Eye-Gaze Assistive Technology for Children and Youth With Complex Needs (NCT04377893) | Clinical Trial Compass
CompletedNot Applicable
Applying Eye-Gaze Assistive Technology for Children and Youth With Complex Needs
Sweden5 participantsStarted 2019-09-19
Plain-language summary
The purpose of this research is to investigate the impacts of applying eye-gaze assistive technology (AT) in children and youth with severe disabilities and complex needs in Taiwan, where eye-gaze AT has not been researched for children yet.
Who can participate
Age range
1 Year – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with severe physical disability without speaking abilities or with communication difficulties (level III\~V on the Communication Function Classification System (CFCS); level IV\~V on the Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS);
* Children have intentions to communicate using body movement, sounds, facial expressions or others, measured by Communication Matrix (Rowland, 2010) with some emerging skills in level 3;
* No or limited possibilities to interact with computers using an input method other than EGAT (e.g. switch or touchpads)
* With access to eye-gazed AT but not used it in daily routines; if possible, new to eye-gaze AT;
* The parent or the teacher agrees to participate in supporting children to use eye-gaze AT in everyday life during the research period;
* The therapist who has worked with the child demonstrated motivation to participate in this intervention.
Exclusion Criteria:
* Progressive diseases that caused functional declines, or serious illness
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Computer Use Diary
Timeframe: is collected everyday for 8 months.
2
Changes of Canadian Occupational Performance Measure (COPM)
Timeframe: The performance of COPM is monitored twice a week using the proxy ratings by parent or the teacher for 8 months. The satisfaction of COPM is measured at baseline, 3 months and 6 months since intervention provision.
3
Changes of Goal Attainment Scaling (GAS)
Timeframe: is collected at 3 months and 6 months since intervention provision.