<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426903</url>
  </required_header>
  <id_info>
    <org_study_id>490</org_study_id>
    <nct_id>NCT04426903</nct_id>
  </id_info>
  <brief_title>Application of LLM Care and Related Affective Computing Systems on People With Parkinson's Disease</brief_title>
  <acronym>pdLLM</acronym>
  <official_title>Application of Cognitive and Physical Training (LLM Care) and Related Affective Computing Systems on People With Parkinson's Disease (Movement Disorders)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the&#xD;
      subsequent LLM Care (NCT02313935) projects in patients with Parkinson's Disease (PD). The&#xD;
      study aims to examine the viability and any potential benefits of cognitive and physical&#xD;
      training, as offered via the ICT-based (non-pharmacological) intervention of LLM Care, on&#xD;
      people with PD. It is worth investigating whether this intervention can offer a better&#xD;
      quality of life in patients with PD and counterbalance the often associated with the PD&#xD;
      disease neurodegeneration. To evaluate any physical, cognitive, behavioral, and neuroplastic&#xD;
      changes and measure the influence (affective status of participant) of the training on the&#xD;
      pathological population, the study utilizes somatometric and neuropsychological assessments&#xD;
      and neuroscientific (electroencephalographic, EEG-related) indices, as well as affective&#xD;
      computing systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parkinson's Disease (PD) is a highly prevalent chronic neurodegenerative disease of the&#xD;
      central nervous system, with both motor and non-motor symptoms, having a high impact on the&#xD;
      quality of life of the patients. There is still no cure available for individuals with PD but&#xD;
      only pharmaceutical treatments that manage the symptoms, thus non-pharmaceutical treatments&#xD;
      such as physical and cognitive training are of great importance. This study aims to evaluate&#xD;
      the benefits of the LLM Care (NCT02313935) Integrated Healthcare System&#xD;
      (https://www.llmcare.gr/en/home/), which is a successful example of commercializing the LLM&#xD;
      (NCT02267499) research program (http://www.longlastingmemories.eu/), in patients with PD. The&#xD;
      LLM Care (non-pharmaceutical) intervention is an integrated training system that targets&#xD;
      nondemented and demented aging population and adopts an approach of cognitive and physical&#xD;
      training to improve the quality of life and prolong the functionality of the elders. The&#xD;
      physical training (PT) component of the LLM, WebFitForAll, was developed by the research team&#xD;
      of the Medical Physics Laboratory, Department of Medicine, Aristotle University of&#xD;
      Thessaloniki. WebFitForAll is an effective physical platform that strengthens the body and&#xD;
      enhances aerobic capacity, flexibility, and balance. The cognitive training (CT) component of&#xD;
      the LLM is a Greek adaptation of the BrainHQ online interactive environment, and comprises&#xD;
      six categories with 29 brain exercises with hundred levels of difficulty. The exercises focus&#xD;
      on attention, memory, brain speed, people skills, navigation, and intelligence. The target&#xD;
      population is PD patients which were classified according to their cognitive state as&#xD;
      PD-cognitively normal (PD-CN) and PD-mild cognitive impairment (PD-MCI). Both PD-CN and&#xD;
      PD-MCI followed similar training schemes of the intervention, two times per week for one hour&#xD;
      for a total of 10 weeks (aiming at 20 sessions/individual). Specifically, the patients were&#xD;
      categorized as follows: (i) LLM training group, where participants attended a training&#xD;
      protocol consisting of pseudo-randomized physical and cognitive exercises (30 minutes of&#xD;
      cognitive and 30 minutes of physical training), (ii) physical training group, whereas&#xD;
      participants underwent only physical training (one hour of physical training), and (iii)&#xD;
      cognitive training group, in which participants performed cognitive tasks (one hour of&#xD;
      cognitive training). The main goal of this study is to quantify the effects of implementing&#xD;
      the LLM Care intervention on patients with PD, determine any benefits in physical status,&#xD;
      cognition, behavior, and brain function, and eventually assess if adopting a cognitively and&#xD;
      physically stimulating lifestyle can offer a better quality of life in this pathological&#xD;
      group. All of the patients were evaluated at baseline (pre) and exit (post) via EEG measures&#xD;
      and a battery of routinely used clinical and neuropsychological tests. Additionally, the&#xD;
      training platform utilizes affective computing systems to evaluate the affective status of&#xD;
      all participants throughout the training and to establish a pleasant learning environment for&#xD;
      all participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants are assigned to a group following different interventions</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in current density strength of the cortical activity as measured via EEG.</measure>
    <time_frame>2 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the cortical directed connectivity as measured via EEG</measure>
    <time_frame>2 months</time_frame>
    <description>Changes in the cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Phase Transfer Entropy (PTE) estimated from the cortical activity, as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings, before compared to after the training.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the graph theory indexes as measured via EEG</measure>
    <time_frame>2 months</time_frame>
    <description>Changes in the global and local graph theoretical indexes of the brain networks caused via the training. Change is defined as statistically significance in the t-test comparison of the graph theory indexes, before compared to after the training.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical capacity (mobility)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in walking speed as measured via the 10 Meter Walk test (Walking Speed m/s; Household Ambulator: &lt;0.40 m/s; Limited Community Ambulator: 0.40 to &lt;0.80 m/s; Community Ambulator: ≥0.80 m/s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical capacity (gait and balance, fall risk)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in gait and balance, and fall risk as measured via the Tinetti POMA (scale: 0-28; gait is scored over 12; balance is scored over 16; perfect: 28; the lower the score on the Tinetti test, the higher the risk of falling; High risk of fall: ≤ 18; Moderate risk of fall: 19-23; Low risk of fall≥ 24)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight index</measure>
    <time_frame>2 months</time_frame>
    <description>BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fitness</measure>
    <time_frame>2 months</time_frame>
    <description>Change in Fitness. Change in aerobic fitness, strength, and flexibility as measured via the Fullerton Senior Fitness Test (SFT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical capacity (balance &amp; mobility)</measure>
    <time_frame>2 months</time_frame>
    <description>Community Balance &amp; Mobility: balance and mobility, scale: 0-96 perfect:96</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical capacity (Functional mobility)</measure>
    <time_frame>2 months</time_frame>
    <description>Berg Balance Scale: functional mobility, scale: 0-56 perfect:56</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life index</measure>
    <time_frame>2 months</time_frame>
    <description>PDQ-8: activities of daily living, attention and working memory, communication, depression, quality of life, and social relationships in persons with Parkinson's Disease, scale: 0-100 (0: good health, 100: poor health)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>2 months</time_frame>
    <description>GDS: depressive symptoms, scale: 0-15 (normal: 0-5; mild depression: 5-8; moderate depression: 9-11; severe depression: 12-15)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical capacity (general)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12, perfect 12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive capacity (functional)</measure>
    <time_frame>2 months</time_frame>
    <description>MMSE: orientation, attention, memory, language and visual-spatial skills, scale: 0-30 perfect:30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive capacity (Visuospatial attention)</measure>
    <time_frame>2 months</time_frame>
    <description>Change in visuospatial attention as measured via Trail Making Test (TMT, duration of completion)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive capacity</measure>
    <time_frame>2 months</time_frame>
    <description>Change in cognitive function as measured via the Montreal Cognitive Assessment (MOCA, scale: 0-30; perfect: 30; normal: ≥26)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>LLM Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LLM Care training Participants use the webFitForAll exergaming computer platform as the physical training component (PT); Participants use the language adapted version of the BrainHQ Program as the cognitive training component (CT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Training (PT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical training only. Participants use the webFitForAll exergaming computer platform as the physical training component (PT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Training (CT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive training only. Participants use the language adapted Version of the BrainHQ Program as the cognitive training component (CT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>webFitForAll</intervention_name>
    <description>PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)</description>
    <arm_group_label>LLM Care</arm_group_label>
    <arm_group_label>Physical Training (PT)</arm_group_label>
    <other_name>PT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>BrainHQ</intervention_name>
    <description>CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)</description>
    <arm_group_label>Cognitive Training (CT)</arm_group_label>
    <arm_group_label>LLM Care</arm_group_label>
    <other_name>CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 50 years and older&#xD;
&#xD;
          2. Native level speakers of the Greek language&#xD;
&#xD;
          3. Able to commit for the required intervention time&#xD;
&#xD;
          4. No significant mobility problems (upper or lower limbs)&#xD;
&#xD;
          5. Normal or corrected to normal visual and auditory acuity&#xD;
&#xD;
          6. In case of any chronic diseases, such as hypertension, diabetes, etc., there should be&#xD;
             advice from the competent doctor&#xD;
&#xD;
          7. No serious cardiovascular problems&#xD;
&#xD;
          8. Mild physical activity supervised by a physician&#xD;
&#xD;
          9. Stable medication so as not to affect the patient's functionality from Parkinson's&#xD;
             motor symptoms (e.g., stiffness, dyskinesia, restlessness, gait disorder and&#xD;
             instability, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of serious neurological diseases or psychiatric illness&#xD;
&#xD;
          2. Recent (within 6 months) history of stroke, transient ischemic stroke episode,&#xD;
             traumatic brain injury, ALS, multiple sclerosis&#xD;
&#xD;
          3. Substance abuse&#xD;
&#xD;
          4. Use of acetylcholinesterase inhibitor is not excluded, as long as its use has started&#xD;
             4 months before joining the study, and is stable during its course study remains&#xD;
             constant&#xD;
&#xD;
          5. Significant communication disorders&#xD;
&#xD;
          6. Simultaneous enrolment in other studies&#xD;
&#xD;
          7. Patients suspected of not being able or willing to cooperate or comply with study&#xD;
             protocol requirements&#xD;
&#xD;
          8. Statin users may be excluded unless during the study the use is constant&#xD;
&#xD;
          9. Patients diagnosed in stages 4 and 5 of the disease, or have undergone surgical&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Panagiotis D bamidis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laboratory of Medical Physics, AUTH</name>
      <address>
        <city>Thessaloniki</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>29968606</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28113566</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25945260</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>July 17, 2021</last_update_submitted>
  <last_update_submitted_qc>July 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Panos Bamidis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Physical Training</keyword>
  <keyword>Cognitive Training</keyword>
  <keyword>EEG</keyword>
  <keyword>Neuroplasticity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426903
org study id: 490
nct id: NCT04426903
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is an adaptation of the Long Lasting Memories (LLM) (NCT02267499) and the
      subsequent LLM Care (NCT02313935) projects in patients with Parkinson's Disease (PD). The
      study aims to examine the viability and any potential benefits of cognitive and physical
      training, as offered via the ICT-based (non-pharmacological) intervention of LLM Care, on
      people with PD. It is worth investigating whether this intervention can offer a better
      quality of life in patients with PD and counterbalance the often associated with the PD
      disease neurodegeneration. To evaluate any physical, cognitive, behavioral, and neuroplastic
      changes and measure the influence (affective status of participant) of the training on the
      pathological population, the study utilizes somatometric and neuropsychological assessments
      and neuroscientific (electroencephalographic, EEG-related) indices, as well as affective
      computing systems.
Parkinson's Disease (PD) is a highly prevalent chronic neurodegenerative disease of the
      central nervous system, with both motor and non-motor symptoms, having a high impact on the
      quality of life of the patients. There is still no cure available for individuals with PD but
      only pharmaceutical treatments that manage the symptoms, thus non-pharmaceutical treatments
      such as physical and cognitive training are of great importance. This study aims to evaluate
      the benefits of the 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/), in patients with PD. 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
      physical training (PT) component of the LLM, WebFitForAll, was developed by the research team
      of the Medical Physics Laboratory, Department of Medicine, Aristotle University of
      Thessaloniki. WebFitForAll is an effective physical platform that strengthens the body and
      enhances aerobic capacity, flexibility, and balance. The cognitive training (CT) component of
      the LLM is a Greek adaptation of the BrainHQ online interactive environment, and comprises
      six categories with 29 brain exercises with hundred levels of difficulty. The exercises focus
      on attention, memory, brain speed, people skills, navigation, and intelligence. The target
      population is PD patients which were classified according to their cognitive state as
      PD-cognitively normal (PD-CN) and PD-mild cognitive impairment (PD-MCI). Both PD-CN and
      PD-MCI followed similar training schemes of the intervention, two times per week for one hour
      for a total of 10 weeks (aiming at 20 sessions/individual). Specifically, the patients were
      categorized as follows: (i) LLM training group, where participants attended a training
      protocol consisting of pseudo-randomized physical and cognitive exercises (30 minutes of
      cognitive and 30 minutes of physical training), (ii) physical training group, whereas
      participants underwent only physical training (one hour of physical training), and (iii)
      cognitive training group, in which participants performed cognitive tasks (one hour of
      cognitive training). The main goal of this study is to quantify the effects of implementing
      the LLM Care intervention on patients with PD, determine any benefits in physical status,
      cognition, behavior, and brain function, and eventually assess if adopting a cognitively and
      physically stimulating lifestyle can offer a better quality of life in this pathological
      group. All of the patients were evaluated at baseline (pre) and exit (post) via EEG measures
      and a battery of routinely used clinical and neuropsychological tests. 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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to a group following different interventions
primary purpose: Other
masking: None (Open Label)
measure: Change in current density strength of the cortical activity as measured via EEG.
time frame: 2 months
description: 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.
measure: Changes in the cortical directed connectivity as measured via EEG
time frame: 2 months
description: Changes in the cortical connectivity caused via the training. Change is defined as statistical significance in the t-test comparison of the Phase Transfer Entropy (PTE) estimated from the cortical activity, as reconstructed via Low Resolution Electromagnetic Tomography (LORETA) algorithm on the basis of high-density EEG recordings, before compared to after the training.
measure: Changes in the graph theory indexes as measured via EEG
time frame: 2 months
description: Changes in the global and local graph theoretical indexes of the brain networks caused via the training. Change is defined as statistically significance in the t-test comparison of the graph theory indexes, before compared to after the training.
measure: Physical capacity (mobility)
time frame: 2 months
description: Change in walking speed as measured via the 10 Meter Walk test (Walking Speed m/s; Household Ambulator: <0.40 m/s; Limited Community Ambulator: 0.40 to <0.80 m/s; Community Ambulator: ≥0.80 m/s)
measure: Change in physical capacity (gait and balance, fall risk)
time frame: 2 months
description: Change in gait and balance, and fall risk as measured via the Tinetti POMA (scale: 0-28; gait is scored over 12; balance is scored over 16; perfect: 28; the lower the score on the Tinetti test, the higher the risk of falling; High risk of fall: ≤ 18; Moderate risk of fall: 19-23; Low risk of fall≥ 24)
measure: Body Weight index
time frame: 2 months
description: BMI
measure: Fitness
time frame: 2 months
description: Change in Fitness. Change in aerobic fitness, strength, and flexibility as measured via the Fullerton Senior Fitness Test (SFT)
measure: Physical capacity (balance & mobility)
time frame: 2 months
description: Community Balance & Mobility: balance and mobility, scale: 0-96 perfect:96
measure: Physical capacity (Functional mobility)
time frame: 2 months
description: Berg Balance Scale: functional mobility, scale: 0-56 perfect:56
measure: Quality of life index
time frame: 2 months
description: PDQ-8: activities of daily living, attention and working memory, communication, depression, quality of life, and social relationships in persons with Parkinson's Disease, scale: 0-100 (0: good health, 100: poor health)
measure: Depression
time frame: 2 months
description: GDS: depressive symptoms, scale: 0-15 (normal: 0-5; mild depression: 5-8; moderate depression: 9-11; severe depression: 12-15)
measure: Physical capacity (general)
time frame: 2 months
description: Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12, perfect 12)
measure: Cognitive capacity (functional)
time frame: 2 months
description: MMSE: orientation, attention, memory, language and visual-spatial skills, scale: 0-30 perfect:30
measure: Cognitive capacity (Visuospatial attention)
time frame: 2 months
description: Change in visuospatial attention as measured via Trail Making Test (TMT, duration of completion)
measure: Cognitive capacity
time frame: 2 months
description: Change in cognitive function as measured via the Montreal Cognitive Assessment (MOCA, scale: 0-30; perfect: 30; normal: ≥26)
arm group label: LLM Care
arm group type: Experimental
description: LLM Care training Participants use the webFitForAll exergaming computer platform as the physical training component (PT); Participants use the language adapted version of the BrainHQ Program as the cognitive training component (CT)
arm group label: Physical Training (PT)
arm group type: Experimental
description: Physical training only. Participants use the webFitForAll exergaming computer platform as the physical training component (PT).
arm group label: Cognitive Training (CT)
arm group type: Experimental
description: Cognitive training only. Participants use the language adapted Version of the BrainHQ Program as the cognitive training component (CT).
intervention type: Other
intervention name: webFitForAll
description: PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)
arm group label: LLM Care
arm group label: Physical Training (PT)
other name: PT
intervention type: Other
intervention name: BrainHQ
description: CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)
arm group label: Cognitive Training (CT)
arm group label: LLM Care
other name: CT
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: Panagiotis D bamidis, PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: Greece
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.
PMID: 29968606
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.
PMID: 28113566
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.
PMID: 25945260
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Panos Bamidis
investigator title: Professor
mesh term: Parkinson Disease
sharing ipd: No