Down SyndromedsLLMNCT04390321
Application of LLM Care and Related Affective Computing Systems on Persons With Special Needs
A study testing LLMcare in people with Down Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- LLMcare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGreece
- Study dates
- 22 Feb 2017to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Down syndrome individuals
Who cannot join
- Ability to execute the physical training protocol
- Ability to execute the cognitive training protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on Persons With Special Needs (Cognitive Disorders)
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- LLMcare
- Keywords
- Down Syndrome, Physical training, Cognitive training, EEG
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLMcareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Down Syndrome LLMcare | Experimental | Individuals with Down Syndrome which are able to execute the LLMcare physical and cognitive training intervention Receives: Other: LLMcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive capacity (functional)
Change in cognitive functions as measured via the battery test WISC-III.
Measured: 2 months
Physical capacity (general)
Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12)
Measured: 2 months
Secondary outcomes (10)
Cognitive capacity (verbal and non-verbal)
Change in verbal and non-verbal mental capabilities, as measured via the Ravens test.
Measured: 2 months
Cognitive capacity (emotion identification)
Change in emotion identification as measured via the "Reading the mind in the eye" test
Measured: 2 months
Physical capacity (mobility)
Change in functional mobility, gait and vestibular function as measured via the 10 Meter Walk test (timed score).
Measured: 2 months
Physical capacity (flexibility)
Change in flexibility (especially in the lower back) as measured via the Sit and Reach test.
Measured: 2 months
Physical capacity (upper body strength)
Change in upper body strength and endurance as measured via the Arm Curl test.
Measured: 2 months
Physical capacity (balance)
Change in static balance as measured via the Stork Balance test (each leg, timed test).
Measured: 2 months
Physical capacity (stability)
Change in dynamic stability as measured by the Four Square Step Test (FSST).
Measured: 2 months
Physical capacity (mobility and balance)
Change in mobility, static and dynamic balance as measured via the Timed Up and Go test (timed test).
Measured: 2 months
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
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start22 Feb 2017
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants are assigned to a single group following the same intervention
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panos Bamidis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390321
- Sponsor's protocol ID
- 488
- Acronym
- dsLLM
- Status last verified
- May 2023
- First submitted
- 12 May 2020
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29968606Konstantinidis 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.
PubMed 28113566Styliadis 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.
PubMed 25945260Anagnostopoulou 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.
PubMed 33688615
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on Persons With Special Needs (Cognitive Disorders)
- ClinicalTrials.gov ID
- NCT04390321
- Acronym / sponsor ID
- dsLLM / 488
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Physical training, Cognitive training, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants are assigned to a single group following the same intervention
| Arm | Type | Receives |
|---|---|---|
| Down Syndrome LLMcare | Experimental | Other: LLMcareIndividuals with Down Syndrome which are able to execute the LLMcare physical and cognitive training intervention |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Down syndrome individuals
Key exclusion criteria (2 listed)
- Ability to execute the physical training protocol
- Ability to execute the cognitive training protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLMcareParticipants 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. | Other | Down Syndrome LLMcare |
Primary outcome
Cognitive capacity (functional)
Time frame: 2 months
Change in cognitive functions as measured via the battery test WISC-III.
Physical capacity (general)
Time frame: 2 months
Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12)
10 secondary outcomes
Cognitive capacity (verbal and non-verbal)
Time frame: 2 months
Cognitive capacity (emotion identification)
Time frame: 2 months
Physical capacity (mobility)
Time frame: 2 months
Physical capacity (flexibility)
Time frame: 2 months
Physical capacity (upper body strength)
Time frame: 2 months
Physical capacity (balance)
Time frame: 2 months
Physical capacity (stability)
Time frame: 2 months
Physical capacity (mobility and balance)
Time frame: 2 months
Change in current density strength of the cortical activity as measured via EEG
Time frame: 2 months
Change in cortical connectivity as measured via EEG
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 29968606Savvidis 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.
- Background: PubMed 28113566Konstantinidis 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.
- Background: PubMed 25945260Styliadis 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.
- Derived from this study: PubMed 33688615Anagnostopoulou 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LLMcare in people with Down Syndrome, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive capacity (functional) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390321, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.