An interventional study of Robot-Assisted Therapy using Kebbi Air and Sensory Integration Therapy in Autism Spectrum Disorder, Emotional Regulation and Sensory Integration Dysfunction, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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Among 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital — 14 open to participants now, 16 under way, none of them phase 3. Autism Spectrum Disorder · National Taiwan University Hospital.
Among the 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital, this one is the 19th largest by planned enrollment of the 20 interventional ones that give a count, is one of 3 that started in 2025, is one of 20 with no phase, reaches primary completion later than 1 of the 15 other live ones, and was the 35th registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →14 of the 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital are open now, in 1 country. Recruiting first, the newest first:
National Taiwan University Hospital · Sites in Taiwan
Ages 4–10
National Taiwan University Hospital · Sites in Taiwan
Ages 4–10
National Taiwan University Hospital · Sites in Taiwan
Ages 3–11
National Taiwan University Hospital · Sites in Taiwan
Ages 4–15
National Taiwan University Hospital · Sites in Taiwan
Ages 18–50
By country, each count listing its studies:
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 4 Years to 6 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
42 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2025.
This study's planned enrollment of 12 is below the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 55 across the 20 interventional studies, 249 across the 22 observational. Of the 22 that completed or were terminated, 1 (5%) have results posted.
This tab as a report to print or save as PDF → With an account.
National Taiwan University Hospital is the lead sponsor of 2,617 studies on the registry; 578 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
3 of the studies in Autism Spectrum Disorder by National Taiwan University Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07775937National Taiwan University HospitalSocial Robots and Board Games for Children With Autism Spectrum Disorder | 2026-11-30 |
| NCT06677840National Taiwan University HospitalExploring the Gut-Brain-Behavior Axis With Biomarkers, Probiotic Efficacy, and Artificial Intelligence Algorithms | 2027-04-30 |
| NCT05857813National Taiwan University HospitalSocial Skills Training Group Effectiveness in Adolescents With Autism Spectrum Disorder | 2027-07-12 |
Add all 3 to your calendar (.ics) → With an account.
Among the 42 studies in Autism Spectrum Disorder by National Taiwan University Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is designed to evaluate and compare the impact of robot-assisted intervention using a smart robot (Kebbi Air) and traditional sensory integration therapy on improving social-emotional skills in children diagnosed with autism spectrum disorder (ASD) or suspected ASD. The study will enroll children aged 4 to 6 years, who will be randomly assigned to one of two groups: the experimental group, which will participate in guided interactions with the smart robot, or the control group, which will receive sensory integration therapy tailored to enhance emotional and social functioning.
The research aims to explore whether interactions with the robot, which are designed to simulate real-world social scenarios, can provide comparable or enhanced benefits compared to traditional sensory integration methods. Pre- and post-intervention assessments will be conducted over a 12-week period, using tools like the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) to measure changes in emotional regulation, sensory processing abilities, and social engagement. The study hypothesizes that the robot-assisted intervention will offer a novel, engaging, and effective approach to supporting the developmental needs of children with ASD.
This study aims to evaluate the effectiveness of robot-assisted intervention compared to traditional sensory integration therapy in improving social-emotional regulation skills in children aged 4-6 years diagnosed with autism spectrum disorder (ASD) or suspected ASD. The research is designed as a randomized controlled trial with 12 participants divided into two groups: the experimental group and the control group.
Participants in the experimental group will interact with a smart robot (Kebbi Air) equipped with interactive scripts tailored to simulate real-life social scenarios. These interactions aim to teach emotional regulation and social skills through structured, engaging activities. The control group will receive sensory integration therapy provided by occupational therapists, focusing on enhancing sensory processing and emotional stability through activities targeting visual, auditory, and tactile stimuli.
The intervention will be conducted over a period of 12 weeks, with participants attending weekly 30-minute sessions. Assessments will be conducted before and after the intervention to measure its impact. Tools such as the Achenbach System of Empirically Based Assessment (ASEBA) and the Sensory Processing Measure (SPM) will be used to evaluate changes in emotional regulation, sensory processing, and social skills.
This study hypothesizes that the robot-assisted intervention will be as effective as or even superior to traditional sensory integration therapy, offering an engaging alternative for children with ASD. By combining cutting-edge technology with therapeutic strategies, the research seeks to provide insights into innovative approaches for supporting children's development, with the potential to inform future practices and interventions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in this group will engage with the Kebbi Air smart robot, which delivers scripted social-emotional skill-building activities over a 12-week period.
Device: Robot-Assisted Therapy using Kebbi Air
Participants in this group will receive traditional sensory integration therapy, guided by occupational therapists, focusing on improving sensory processing and social-emotional regulation.
Behavioral: Sensory Integration Therapy
Participants in this group will engage with the Kebbi Air smart robot, which is programmed with interactive scripts designed to enhance social-emotional regulation skills. The intervention includes weekly 30-minute sessions over a 12-week period, where the robot simulates real-life social scenarios and provides verbal and visual responses to guide participants in developing emotional and social skills. Occupational therapists will supervise these sessions to ensure the appropriateness of interactions and provide additional support as needed.
Participants in this group will receive traditional sensory integration therapy guided by occupational therapists. The therapy focuses on improving sensory processing and emotional regulation through structured activities targeting visual, auditory, and tactile stimuli. Each session is conducted weekly, lasting 30 minutes, for a total of 12 weeks. The therapy aims to help children adapt to sensory inputs and enhance their ability to engage in social interactions and manage emotions effectively.
Social-Emotional Regulation Skills
Changes in emotional regulation, including anxiety, withdrawal, and aggression, were assessed using the Achenbach System of Empirically Based Assessment (ASEBA), specifically the Child Behavior Checklist for Ages 1½-5 (CBCL/1½-5). This caregiver-reported tool evaluates behavioral and emotional functioning in children aged 1.5 to 5 years. It assesses seven syndrome scales, including Emotional Reactivity, Anxiety/Depression, Somatic Complaints, Withdrawal, Attention Problems, Aggressive Behavior, and Sleep Problems. DSM-oriented scales identify issues such as affective, anxiety, and attention-deficit/hyperactivity problems. Items are rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Very True), with higher scores indicating greater severity. This tool tracks changes in emotional regulation over time.
Time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).
Sensory Processing Abilities
Sensory processing challenges and their impact on social participation were evaluated using the Sensory Processing Measure (SPM), a standardized tool for children aged 5 to 12 years. The SPM identifies sensory difficulties across domains: Social Participation, Vision, Hearing, Touch, Body Awareness (Proprioception), Balance and Motion (Vestibular), and Planning and Ideas (Praxis). Items are rated on a 4-point Likert scale (1 = Never, 4 = Always). Scores are categorized as Typical, Some Problems, or Definite Dysfunction, with higher scores indicating greater challenges. The SPM provides insights into how sensory processing affects a child's behavior and participation across various environments.
Time frame: Baseline (pre-intervention) and after 12 weeks (post-intervention).
No study locations are listed for this record.
Plan to share: Undecided — The investigators have not yet decided whether to share Individual Participant Data (IPD). The primary reasons include the need to consider privacy protection regulations, institutional policies, and the sensitive nature of the collected data. Additionally, the investigators need to ensure that data sharing can be conducted in compliance with ethical guidelines. The research team plans to evaluate the feasibility of data sharing after the study is completed, taking into account practical considerations and recommendations from regulatory authorities or ethics committees.
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Jan 2025, 0 months later.
Of 802 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 0 months is below that.
Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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