Self-Help DevicesNCT04377893
Applying Eye-Gaze Assistive Technology for Children and Youth With Complex Needs
A study testing Eye gaze AT intervention in people with Self-Help Devices and Eye-Gaze Technology, run by Yu-Hsin Hsieh at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Self-Help Devices, Eye-Gaze Technology, Severe Physical Disabilities
- What is being tested?
- Eye gaze AT intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- 19 Sep 2019to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Progressive diseases that caused functional declines, or serious illness
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Special Education, Stockholm University
Stockholm, Sverige, 10691
About this study
Official title: Applying Eye-Gaze Assistive Technology in Daily Life for Children and Youth With Severe Physical Disabilities and Complex Communication Needs
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.
Read the 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.
- Conditions
- Self-Help Devices, Eye-Gaze Technology, Severe Physical Disabilities, Communication Disorders
- Being tested
- Eye gaze AT intervention
- Keywords
- Eye-Gaze Assistive Technology, Severe Physical Disabilities, Communication difficulties
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye gaze AT interventionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Participants will receive eye-gaze AT intervention Receives: Device: Eye gaze AT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: is collected at 3 months and 6 months since intervention provision.
Secondary outcomes (5)
Communication Matrix
to evaluate the communicative functions for early communication behaviors through a telephone or face to face interview with proxy persons.
Measured: is measured at baseline, 3 months and 6 months since intervention provision.
Chinese version of Psychosocial Impact of Assistive Devices Scale (PIADS-C)
is used to assess the impact of AT on the subjective well-being of end users by proxy persons, including three subscales of competence, adaptability and self-esteem. Each subscale score ranges from -3 to +3, and higher scores indicate better outcomes.
Measured: is measured at baseline (if the child uses other AT for communication) and after 6-month intervention.
KIDSCREEN-10 parent version
to evaluate child´s physical, psychological and social well-being. Items are answered on a 5-point Likert-type scale and responses are summed and transformed into T-score with a mean of 50 and a standard deviation of approximately 10. A high score is indicative of a better health-related quality of life.
Measured: is measured at baseline and after 6-month intervention.
The Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology (T- QUEST)
to evaluate parents' and teachers' satisfaction with the eye-gazed AT as an assistive device and with the service provided related to the eye-gazed AT. Each item ranges from 1 "Not satisfied at all" to 5 "Very satisfied." Higher values represent higher satisfaction.
Measured: is measured after 6-month intervention.
COMPASS Aim test
to measure the eye gaze performance (time on task and accuracy) with the eye-gazed AT.
Measured: Five trials with 12 targets in each trial will be conducted at baseline, 3 months and 6 months since intervention provision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start19 Sep 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-Help DevicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Hsin Hsieh
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University, Jonkoping University, Folke Bernadotte Stiftelsen, Stiftelsen Kempe-Carlgrenska Fonden, Stiftelsen Clas Groschinskys Minnesfond, Helge Ax:son Johnsons Stiftelse
- Responsible party
- Sponsor-investigator, Yu-Hsin Hsieh, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04377893
- Sponsor's protocol ID
- CGUSU180116
- Status last verified
- Sep 2021
- First submitted
- 22 Apr 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh YH, Granlund M, Odom SL, Hwang AW, Hemmingsson H. Increasing participation in computer activities using eye-gaze assistive technology for children with complex needs. Disabil Rehabil Assist Technol. 2024 Feb;19(2):492-505. doi: 10.1080/17483107.2022.2099988. Epub 2022 Jul 21.
PubMed 35861506
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Eye-Gaze Assistive Technology in Daily Life for Children and Youth With Severe Physical Disabilities and Complex Communication Needs
- ClinicalTrials.gov ID
- NCT04377893
- Acronym / sponsor ID
- CGUSU180116
- Conditions
- Self-Help Devices, Eye-Gaze Technology, Severe Physical Disabilities, Communication Disorders
- Keywords
- Eye-Gaze Assistive Technology, Severe Physical Disabilities, Communication difficulties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yu-Hsin HsiehUniversity, hospital or other
- Collaborators
- Chang Gung University, Jonkoping University, Folke Bernadotte Stiftelsen, Stiftelsen Kempe-Carlgrenska Fonden, Stiftelsen Clas Groschinskys Minnesfond, Helge Ax:son Johnsons Stiftelse
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: Eye gaze AT interventionParticipants will receive eye-gaze AT intervention |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (1 listed)
- Progressive diseases that caused functional declines, or serious illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye gaze AT interventionThe 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. | Device | Treatment arm |
Primary outcome
The Computer Use Diary
Time frame: is collected everyday for 8 months.
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.
Changes of Canadian Occupational Performance Measure (COPM)
Time frame: 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.
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.
Changes of Goal Attainment Scaling (GAS)
Time frame: is collected at 3 months and 6 months since intervention provision.
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)
5 secondary outcomes
Communication Matrix
Time frame: is measured at baseline, 3 months and 6 months since intervention provision.
Chinese version of Psychosocial Impact of Assistive Devices Scale (PIADS-C)
Time frame: is measured at baseline (if the child uses other AT for communication) and after 6-month intervention.
KIDSCREEN-10 parent version
Time frame: is measured at baseline and after 6-month intervention.
The Taiwanese Version of Quebec User Evaluation of Satisfaction with Assistive Technology (T- QUEST)
Time frame: is measured after 6-month intervention.
COMPASS Aim test
Time frame: Five trials with 12 targets in each trial will be conducted at baseline, 3 months and 6 months since intervention provision.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 35861506Hsieh YH, Granlund M, Odom SL, Hwang AW, Hemmingsson H. Increasing participation in computer activities using eye-gaze assistive technology for children with complex needs. Disabil Rehabil Assist Technol. 2024 Feb;19(2):492-505. doi: 10.1080/17483107.2022.2099988. Epub 2022 Jul 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye gaze AT intervention in people with Self-Help Devices and Eye-Gaze Technology, run by Yu-Hsin Hsieh at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Computer Use Diary (time frame: is collected everyday for 8 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04377893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.