Clinical Study of TheraMate, a digital therapeutic social robot system for in-home therapy of autistic children

Study Objective

Autism spectrum disorder (ASD) is a childhood neurodevelopmental disorder and is often associated with delayed development in the areas of language, motor and cognitive skills among others, affecting 1 in every 54 children. TheraMate is a digital therapeutic system to improve the adaptive behavior, language, cognitive and social abilities of autistic children aged 2 to 8 years old through social robot-delivered caregiver-supported game-based behavioral intervention.

The primary objective is:  

·      to evaluate and validate the effectiveness of TheraMate as a digital therapeutic tool for young autistic children, by comparing the effectiveness of the combined TheraMate and usual care with the control group who only receives the usual care.  

The secondary objectives are:  

·      to conduct a health-economic impact analysis of the TheraMate. In view of that, it is intended to measure the solution as a cost-effective and accessible therapy delivery tool for autism. 

·      to conduct research using the data obtained from this study to evaluate whether the session and progress monitoring reports generated by the TherMate, can be mapped to the standard evaluation tests used by autism professionals, and thus to evaluate whether the TheraMate can be used as an autism assessment tool.  

Participation conditions

Inclusion: 

·       Female or Male  

·       Age between 24 months to 96 months at the start of the intervention  

·       Clinical ASD diagnosis based on DSM V or ICD 10  

·       Family being able to commit to running +10 times of robot sessions/month at home and joining the monthly support webinars

·       Developmental age of 3 years or less on language, cognitive or social skills. 

Exclusion: 

·       Neurodevelopmental disorder of a known etiology (e.g. Fragile x syndrome)

·       Significant sensory or motor impairment, Major serious health conditions, History of serious head injury, or neurological diseases 

·       Alcohol or drug exposure at prenatal  

·       Receiving more than 12 hours per month of 1-to-1 therapy extra than the usual care defined per categories of children based on their age, autism severity and country 

·       History of seizure at the enrolment time  

·       Severe aggressive or oppositional behaviors. 

FAL = Foundation Autism Luxembourg

UK = sites to be confirmed