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Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs

NCT04390321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Down Syndrome

Interventions

OTHER

LLMcare

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.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390321 on ClinicalTrials.gov