Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs
Condition: Down Syndrome
MeSH terms: Down Syndrome
Study type: Interventional

Summary: 
      Down syndrome (DS) is a genetic disorder characterized by specific physical characteristics
      (muscle degeneration) and cognitive phenotype (neurodegeneration caused by
      gene-overexpression that has affected memory, language, and other executive functions). DS is
      the most prevalent reason for intellectual impairment but is also often accompanied by other
      medical conditions such as Alzheimer's disease. Given the increased cognitive decline
      inherent to DS, especially in the later years, the development of a non-invasive intervention
      protocol to counterbalance this prevalence is imperative.

      This study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the
      subsequent LLM Care (NCT02313935) projects, specifically tailored to meet the needs and
      capacity of people with DS. The study aims to examine the effectiveness and any potential
      benefits of cognitive and physical training, as offered via the ICT-based
      (non-pharmacological) intervention of LLM Care, on people with DS. It is worth investigating
      whether this intervention can aid the development of independent living skills in DS
      individuals and the possibility of counterbalancing the degeneration, both physical and
      cognitive, caused by the expression of the extra genes. To evaluate any physical, cognitive,
      behavioral, and neuroplastic benefits/effects and measure the influence (affective status of
      participant) of the training, the study utilizes psycho-somatometric assessments and
      neuroscientific (electroencephalographic, EEG-related) indices, as well as affective
      computing systems.
    

Detailed description: 
      Down Syndrome (DS) is a genetic disorder most commonly attributed to the trisomy of
      chromosome 21. It is considered the most prevalent reason for intellectual impairment. The
      extra chromosomic copy results in gene over-expression, which in turn is responsible for the
      characteristic non-uniform degeneration, affecting both cognition, and physical condition.
      The disorder has been linked to many underlying conditions such as early aging and
      Alzheimer's disease. Considering the cognitive decline that accompanies the increase in age,
      there is a need to develop non-invasive, counterbalancing interventions that will provide
      these individuals with a better quality of life and support them in acquiring and improving
      their skill set.

      The target population is individuals with DS. The participants followed similar training
      schemes of the intervention, two days per week for one hour, for 10 weeks (aiming at 20
      sessions/ participant), for one hour (30 minutes of cognitive and 30 minutes of physical
      training). Specifically, the participants completed the LLMcare protocol (combined cognitive
      and physical training) while a subgroup underwent measurements two times, one month apart,
      before initiating the intervention to serve as control.

      The intervention is a based on LLM Care (NCT02313935) Integrated Healthcare System
      (https://www.llmcare.gr/en/home/) which is a successful example of commercializing the LLM
      (NCT02267499) research program (http://www.longlastingmemories.eu/), and has been customized
      to meet the needs and capacity of people with DS. The LLM Care (non-pharmaceutical)
      intervention is an integrated training system that targets nondemented and demented aging
      population and adopts an approach of cognitive and physical training to improve the quality
      of life and prolong the functionality of the elders.The main goal of this study is to
      quantify the effects of implementing the LLM Care intervention on people with DS, and
      particularly its effect on their physical status, cognition, behavior, and brain function.
      The study can potentially evaluate if adopting a cognitively and physically stimulating
      lifestyle can support DS individuals in acquiring and improving their skill set and act as
      and effective treatment against the physical and cognitive degeneration that is inherent to
      this syndrome The individuals with DS were evaluated via a battery of clinical and
      neuropsychological tests, and EEG measures at baseline (pre), exit (post) and one month after
      the training (follow up). Additionally, the training platform utilizes affective computing
      systems to evaluate the affective status of all participants throughout the training, and to
      establish a pleasant learning environment for all participants.
    

Intervention name(s): LLMcare
Intervention type(s): Other
Intervention description(s): Participants will undergo 20 sessions of computerized cognitive and physical training, during a 2 month period. Both components have a duration of 30 minutes and are consecutive, but their sequence is pseudo-randomized. All sessions are conducted under supervision. Cognitive training uses the greek adaptation of the BrainHQ software (Posit Science Corporation), utilizing audiovisual stimuli, and targets memory, attention, cognitive-processing speed, orientation and social skills. Physical training is based on the WebFitForAll protocol and uses the motion sensor device Kinect. It consists of warm-up, aerobic, flexibility, strength, balance and cool down exercises.
Intervention model: Single Group Assignment
Intervention model description: Participants are assigned to a single group following the same intervention
Masking: None (Open Label)
Primary purpose: Other
Keywords: Down Syndrome; Physical training; Cognitive training; EEG