Clinical trial NCT04377893: Applying Eye-Gaze Assistive Technology for Children and Youth With Complex Needs
Official title: Applying Eye-Gaze Assistive Technology in Daily Life for Children and Youth With Severe Physical Disabilities and Complex Communication Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Help Devices
Eye-Gaze Technology
Severe Physical Disabilities
Communication Disorders
Keywords: Eye-Gaze Assistive Technology
Severe Physical Disabilities
Communication difficulties
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: Chang Gung University
name: Jonkoping University
name: Folke Bernadotte Stiftelsen
name: Stiftelsen Kempe-Carlgrenska Fonden
name: Stiftelsen Clas Groschinskys Minnesfond
name: Helge Ax:son Johnsons Stiftelse
First posted: 2020-05-07
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Background. Children and youth with severe physical disabilities often have concomitant mental impairments and complex needs in communication, and in building relationships with others. The impairments limit their participation and independence in family, school and community life. By using their eyes, the only movements they can control voluntarily, they may increase communication. Relevant research has shown that using eye-gaze AT was feasible for children with severe physical disabilities to make choices, communicate, interact or perform school tasks despite different learning curves. Use of technology may increase opportunities for engagement and self-determination for children and youth with physical disabilities and complex communication needs in family context or in school, but the research is relatively limited. It still needs more studies across countries and long-term follow-up to investigate the effects of the use of eye-gazed AT in life.

Study Aims. There are two aims in this proposed research. Aim 1: To investigate the preliminary effects of eye-gazed AT for daily participation in daily living for children and youth with severe physical disabilities and communication difficulties in Taiwan.

Aim 2: To investigate the adherence of eye-gazed AT intervention for children and youth with severe physical disabilities and communication difficulties, and the caregivers' satisfaction regarding support children and youth to use eye-gazed AT in daily living in Taiwan.

Methods. This study is conducted as a single subject design with multiple baselines across individuals. The inclusions are non-concurrent and the baselines before the intervention started were randomized with unequal of 14-30 days.

This study enrolls participants from Northern Taiwan. The researcher team contacts the practitioners in hospitals, schools or development centers to assist recruitment.

Study procedure. The eye-gaze AT intervention will be conducted for six months and follow up to seven months since provision. Before the intervention started, each of the five participants is randomly assigned to one of the pre-determined baseline lengths (14-30 days).

Repeated measures were conducted in baseline period with a minimum of five data points to judge the stability of the child's abilities and in intervention phase to establish data trends in the levels of two dependent variables, computer usage in daily living (measured by computer use diary along with log data of FocusMe program (FocusMe Inc., London, UK)), and children's activity performance using eye-gaze AT (performance scale of Canadian Occupational Performance Measure (COPM) rated by the parent or teacher). Systematic manipulation of the independent variable, the eye-gaze AT intervention was introduced in the intervention phase. The process was replicated for at least five participants to demonstrate the experiment-control effects.

In addition, other outcomes related to Activity and Participation, Body Functions and Structures and Environmental dimensions based on ICF-CY framework will be collected at baseline, after the 3-month intervention, after the 6-month intervention and 7-month after provision.

Statistical analysis. The visual analysis of single-case data will be used to determine whether there will be a relationship between the independent and dependent variables. The data of continuous variables will be presented as graphs to visually inspected regarding change of data pattern across phases separately.

Due to the small sample size, descriptive statistics will be used to summarize the results of outcome measures and reported using the narrative summary. For COPM, the score change of more than two points is considered clinically signiﬁcant improvement on both performance and satisfaction scale. Besides, achieving the expected level (0) on a GAS goal is considered successful goal attainment.

Eligibility criteria: 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

Primary outcomes:
measure: The Computer Use Diary
timeFrame: is collected everyday for 8 months.
measure: 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.
measure: Changes of Goal Attainment Scaling (GAS)
timeFrame: is collected at 3 months and 6 months since intervention provision.
Secondary outcomes:
measure: Communication Matrix
timeFrame: is measured at baseline, 3 months and 6 months since intervention provision.
measure: Chinese version of Psychosocial Impact of Assistive Devices Scale (PIADS-C)
timeFrame: is measured at baseline (if the child uses other AT for communication) and after 6-month intervention.
measure: KIDSCREEN-10 parent version
timeFrame: is measured at baseline and after 6-month intervention.
measure: The Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology (T- QUEST)
timeFrame: is measured after 6-month intervention.
measure: COMPASS Aim test
timeFrame: Five trials with 12 targets in each trial will be conducted at baseline, 3 months and 6 months since intervention provision.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Special Education, Stockholm University
state: Sverige
Study officials:
References: