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

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
LLMcare
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Down Syndrome focused on measuring Down Syndrome, Physical training, Cognitive training, EEG

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Down syndrome individuals

Exclusion Criteria:

  • Ability to execute the physical training protocol
  • Ability to execute the cognitive training protocol

Sites / Locations

  • Laboratory of Medical Physics, AUTH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Down Syndrome LLMcare

Arm Description

Individuals with Down Syndrome which are able to execute the LLMcare physical and cognitive training intervention

Outcomes

Primary Outcome Measures

Cognitive capacity (functional)
Change in cognitive functions as measured via the battery test WISC-III.
Physical capacity (general)
Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12)

Secondary Outcome Measures

Cognitive capacity (verbal and non-verbal)
Change in verbal and non-verbal mental capabilities, as measured via the Ravens test.
Cognitive capacity (emotion identification)
Change in emotion identification as measured via the "Reading the mind in the eye" test
Physical capacity (mobility)
Change in functional mobility, gait and vestibular function as measured via the 10 Meter Walk test (timed score).
Physical capacity (flexibility)
Change in flexibility (especially in the lower back) as measured via the Sit and Reach test.
Physical capacity (upper body strength)
Change in upper body strength and endurance as measured via the Arm Curl test.
Physical capacity (balance)
Change in static balance as measured via the Stork Balance test (each leg, timed test).
Physical capacity (stability)
Change in dynamic stability as measured by the Four Square Step Test (FSST).
Physical capacity (mobility and balance)
Change in mobility, static and dynamic balance as measured via the Timed Up and Go test (timed test).
Change in current density strength of the cortical activity as measured via EEG
Changes in cortical activity strength caused via the training. Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high density EEG recordings, before compared to after the training
Change in cortical connectivity as measured via EEG
Changes in cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Transfer Entropy estimated from the cortical activity, as reconstructed via LORETA algorithm on the basis of high density EEG recordings, before compared to after the training.

Full Information

First Posted
May 12, 2020
Last Updated
May 3, 2023
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT04390321
Brief Title
Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs
Acronym
dsLLM
Official Title
Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on Persons With Special Needs (Cognitive Disorders)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down Syndrome, Physical training, Cognitive training, EEG

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants are assigned to a single group following the same intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Down Syndrome LLMcare
Arm Type
Experimental
Arm Description
Individuals with Down Syndrome which are able to execute the LLMcare physical and cognitive training intervention
Intervention Type
Other
Intervention Name(s)
LLMcare
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive capacity (functional)
Description
Change in cognitive functions as measured via the battery test WISC-III.
Time Frame
2 months
Title
Physical capacity (general)
Description
Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Cognitive capacity (verbal and non-verbal)
Description
Change in verbal and non-verbal mental capabilities, as measured via the Ravens test.
Time Frame
2 months
Title
Cognitive capacity (emotion identification)
Description
Change in emotion identification as measured via the "Reading the mind in the eye" test
Time Frame
2 months
Title
Physical capacity (mobility)
Description
Change in functional mobility, gait and vestibular function as measured via the 10 Meter Walk test (timed score).
Time Frame
2 months
Title
Physical capacity (flexibility)
Description
Change in flexibility (especially in the lower back) as measured via the Sit and Reach test.
Time Frame
2 months
Title
Physical capacity (upper body strength)
Description
Change in upper body strength and endurance as measured via the Arm Curl test.
Time Frame
2 months
Title
Physical capacity (balance)
Description
Change in static balance as measured via the Stork Balance test (each leg, timed test).
Time Frame
2 months
Title
Physical capacity (stability)
Description
Change in dynamic stability as measured by the Four Square Step Test (FSST).
Time Frame
2 months
Title
Physical capacity (mobility and balance)
Description
Change in mobility, static and dynamic balance as measured via the Timed Up and Go test (timed test).
Time Frame
2 months
Title
Change in current density strength of the cortical activity as measured via EEG
Description
Changes in cortical activity strength caused via the training. Change is defined as statistical significance in the t-test comparison of the current density strength as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high density EEG recordings, before compared to after the training
Time Frame
2 months
Title
Change in cortical connectivity as measured via EEG
Description
Changes in cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Transfer Entropy estimated from the cortical activity, as reconstructed via LORETA algorithm on the basis of high density EEG recordings, before compared to after the training.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Down syndrome individuals Exclusion Criteria: Ability to execute the physical training protocol Ability to execute the cognitive training protocol
Facility Information:
Facility Name
Laboratory of Medical Physics, AUTH
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29968606
Citation
Savvidis TP, Konstantinidis EI, Dias SB, Diniz JA, Hadjileontiadis LJ, Bamidis PD. Exergames for Parkinson's Disease Patients: How Participatory Design Led to Technology Adaptation. Stud Health Technol Inform. 2018;251:78-81.
Results Reference
background
PubMed Identifier
28113566
Citation
Konstantinidis EI, Bamparopoulos G, Bamidis PD. Moving Real Exergaming Engines on the Web: The webFitForAll Case Study in an Active and Healthy Ageing Living Lab Environment. IEEE J Biomed Health Inform. 2017 May;21(3):859-866. doi: 10.1109/JBHI.2016.2559787. Epub 2016 Apr 27.
Results Reference
background
PubMed Identifier
25945260
Citation
Styliadis C, Kartsidis P, Paraskevopoulos E, Ioannides AA, Bamidis PD. Neuroplastic effects of combined computerized physical and cognitive training in elderly individuals at risk for dementia: an eLORETA controlled study on resting states. Neural Plast. 2015;2015:172192. doi: 10.1155/2015/172192. Epub 2015 Apr 7.
Results Reference
background
PubMed Identifier
33688615
Citation
Anagnostopoulou A, Styliadis C, Kartsidis P, Romanopoulou E, Zilidou V, Karali C, Karagianni M, Klados M, Paraskevopoulos E, Bamidis PD. Computerized physical and cognitive training improves the functional architecture of the brain in adults with Down syndrome: A network science EEG study. Netw Neurosci. 2021 Mar 1;5(1):274-294. doi: 10.1162/netn_a_00177. eCollection 2021.
Results Reference
derived

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

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