Applying Eye-Gaze Assistive Technology for Children and Youth With Complex Needs

NCT04377893 | Completed

• 1 other identifier: CGUSU180116
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-Help Devices; Eye-Gaze Technology; Severe Physical Disabilities; Communication Disorders

Keywords

Eye-Gaze Assistive Technology; Severe Physical Disabilities; Communication difficulties

Outcome Measures

Primary Outcomes (3)

• The Computer Use Diary

  to measure the children´s computer usage in daily living throughout the research period. Parents and teachers observe and document the computer use at home, school and/or center, including duration of use for each activity and type and number of computer activities per day. To increase the reliability of using documentation data from parents or teachers, we will compare with log data from the FocusMe program (FocusMe Inc., London, UK) which monitors the duration and types of app/software the children use eye-gaze AT each time to enhance internal validity.

  is collected everyday for 8 months.

• Changes of Canadian Occupational Performance Measure (COPM)

  to interview the parents or teachers to prioritize goals for daily participation activities using an eye-gazed AT and rate the level of children's performance and satisfaction of children's performance using a 10-point scale (1-10). Higher scores means better performance or higher satisfaction on children's performance.

  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.

• Changes of Goal Attainment Scaling (GAS)

  to evaluate the goals of meaningful use in school and at home with eye-gazed AT. The instrument has five levels of scale values from -2 (starting level) to +2 (more than expected)

  is collected at 3 months and 6 months since intervention provision.

Secondary Outcomes (5)

• Communication Matrix

  is measured at baseline, 3 months and 6 months since intervention provision.

• Chinese version of Psychosocial Impact of Assistive Devices Scale (PIADS-C)

  is measured at baseline (if the child uses other AT for communication) and after 6-month intervention.

• KIDSCREEN-10 parent version

  is measured at baseline and after 6-month intervention.

• The Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology (T- QUEST)

  is measured after 6-month intervention.

• COMPASS Aim test

  Five trials with 12 targets in each trial will be conducted at baseline, 3 months and 6 months since intervention provision.

Study Arms (1)

Treatment arm

EXPERIMENTAL

Participants will receive eye-gaze AT intervention

Device: Eye gaze AT intervention

Interventions

Eye gaze AT intervention DEVICE

The eye-gaze AT intervention includes eye-gaze AT and service delivery to support the participants using this technology in daily life. The Tobii PCEye Mini (Tobii, Danderyd, Sweden) and specialized software are applied with adaptation to meet each child's individual needs. To ensure the consistency of service delivery, two-day courses are conducted before the intervention. The participant's teachers or parents are invited as the main interventionist to facilitate the child's usage of eye-gaze AT in daily life under team support. The service delivery involves parents in joint goal-setting, planning, and jointly review the progress of the usage of eye-gaze AT as a family-centered practice. Individual meetings and individual supports are provided during intervention periods. The collaborative team will perform biweekly follow-up contacts during intervention periods. The researcher will conduct the fidelity checklist every month to determine the extent of treatment integrity.

Treatment arm

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Progressive diseases that caused functional declines, or serious illness

Sponsors & Collaborators

• Yu-Hsin Hsieh: lead
• Chang Gung University: collaborator
• Jonkoping University: collaborator
• Folke Bernadotte Stiftelsen: collaborator
• Stiftelsen Kempe-Carlgrenska Fonden: collaborator
• Stiftelsen Clas Groschinskys Minnesfond: collaborator
• Helge Ax:son Johnsons Stiftelse: collaborator

Study Sites (1)

Department of Special Education, Stockholm University

Stockholm, Sverige, 10691, Sweden

Location

MeSH Terms

Conditions

Communication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: May 7, 2020
• Study Start: September 19, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)