Parkinson DiseasepdLLMNCT04426903
Application of LLM Care and Related Affective Computing Systems on People With Parkinson's Disease
A study testing webFitForAll and BrainHQ in people with Parkinson Disease, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- webFitForAll and BrainHQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2017to 1 Jul 2018
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 years and older
- Native level speakers of the Greek language
- Able to commit for the required intervention time
- No significant mobility problems (upper or lower limbs)
- Normal or corrected to normal visual and auditory acuity
- In case of any chronic diseases, such as hypertension, diabetes, etc., there should be advice from the competent doctor
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- No serious cardiovascular problems
- Mild physical activity supervised by a physician
- Stable medication so as not to affect the patient's functionality from Parkinson's motor symptoms (e.g., stiffness, dyskinesia, restlessness, gait disorder and instability, etc.)
Who cannot join
- History of serious neurological diseases or psychiatric illness
- Recent (within 6 months) history of stroke, transient ischemic stroke episode, traumatic brain injury, ALS, multiple sclerosis
- Substance abuse
- Use of acetylcholinesterase inhibitor is not excluded, as long as its use has started 4 months before joining the study, and is stable during its course study remains constant
- Significant communication disorders
- Simultaneous enrolment in other studies
Show all 9Show fewer
- Patients suspected of not being able or willing to cooperate or comply with study protocol requirements
- Statin users may be excluded unless during the study the use is constant
- Patients diagnosed in stages 4 and 5 of the disease, or have undergone surgical treatment
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 People With Parkinson's Disease (Movement Disorders)
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- webFitForAll, BrainHQ
- Keywords
- Physical Training, Cognitive Training, EEG, Neuroplasticity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
webFitForAllOther
Also called PT
PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)
BrainHQOther
Also called CT
CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)
| Study group | Role | What they receive |
|---|---|---|
| LLM Care | Experimental | 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) Receives: Other: webFitForAll; Other: BrainHQ |
| Physical Training (PT) | Experimental | Physical training only. Participants use the webFitForAll exergaming computer platform as the physical training component (PT). Receives: Other: webFitForAll |
| Cognitive Training (CT) | Experimental | Cognitive training only. Participants use the language adapted Version of the BrainHQ Program as the cognitive training component (CT). Receives: Other: BrainHQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in current density strength of the cortical activity as measured via EEG.
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
Changes in the cortical directed connectivity as measured via EEG
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.
Measured: 2 months
Changes in the graph theory indexes as measured via EEG
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.
Measured: 2 months
Secondary outcomes (12)
Physical capacity (mobility)
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)
Measured: 2 months
Change in physical capacity (gait and balance, fall risk)
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)
Measured: 2 months
Body Weight index
BMI
Measured: 2 months
Fitness
Change in Fitness. Change in aerobic fitness, strength, and flexibility as measured via the Fullerton Senior Fitness Test (SFT)
Measured: 2 months
Physical capacity (balance & mobility)
Community Balance \& Mobility: balance and mobility, scale: 0-96 perfect:96
Measured: 2 months
Physical capacity (Functional mobility)
Berg Balance Scale: functional mobility, scale: 0-56 perfect:56
Measured: 2 months
Quality of life index
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)
Measured: 2 months
Depression
GDS: depressive symptoms, scale: 0-15 (normal: 0-5; mild depression: 5-8; moderate depression: 9-11; severe depression: 12-15)
Measured: 2 months
Physical capacity (general)
Change in physical function as measured via the Short Physical Performance Battery (SPPB, scale from 0 to 12, perfect 12)
Measured: 2 months
Cognitive capacity (functional)
MMSE: orientation, attention, memory, language and visual-spatial skills, scale: 0-30 perfect:30
Measured: 2 months
Cognitive capacity (Visuospatial attention)
Change in visuospatial attention as measured via Trail Making Test (TMT, duration of completion)
Measured: 2 months
Cognitive capacity
Change in cognitive function as measured via the Montreal Cognitive Assessment (MOCA, scale: 0-30; perfect: 30; normal: ≥26)
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 posted11 Jun 2020
- Study start1 Mar 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to a group following different interventions
- Masking
- None (open label)
- Enrolment
- 23 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
- Investigators
- Panagiotis D bamidis, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426903
- Sponsor's protocol ID
- 490
- Acronym
- pdLLM
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2020
- Last updated
- 22 Jul 2021
- 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 25945260
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. 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 People With Parkinson's Disease (Movement Disorders)
- ClinicalTrials.gov ID
- NCT04426903
- Acronym / sponsor ID
- pdLLM / 490
- Conditions
- Parkinson Disease
- Keywords
- Physical Training, Cognitive Training, EEG, Neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 11 Jun 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to a group following different interventions
| Arm | Type | Receives |
|---|---|---|
| LLM Care | Experimental | Other: webFitForAll, Other: BrainHQLLM 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) |
| Physical Training (PT) | Experimental | Other: webFitForAllPhysical training only. Participants use the webFitForAll exergaming computer platform as the physical training component (PT). |
| Cognitive Training (CT) | Experimental | Other: BrainHQCognitive training only. Participants use the language adapted Version of the BrainHQ Program as the cognitive training component (CT). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 50 years and older
- Native level speakers of the Greek language
- Able to commit for the required intervention time
- No significant mobility problems (upper or lower limbs)
- Normal or corrected to normal visual and auditory acuity
Key exclusion criteria (9 listed)
- History of serious neurological diseases or psychiatric illness
- Recent (within 6 months) history of stroke, transient ischemic stroke episode, traumatic brain injury, ALS, multiple sclerosis
- Substance abuse
- Use of acetylcholinesterase inhibitor is not excluded, as long as its use has started 4 months before joining the study, and is stable during its course study remains constant
- Significant communication disorders
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 |
|---|---|---|
| webFitForAllAlso: PTPT training participants use the webFitForAll exergaming computer platform as the physical training component (PT) | Other | LLM Care, Physical Training (PT) |
| BrainHQAlso: CTCT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT) | Other | Cognitive Training (CT), LLM Care |
Primary outcome
Change in current density strength of the cortical activity as measured via EEG.
Time frame: 2 months
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.
Changes in the cortical directed connectivity as measured via EEG
Time frame: 2 months
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.
Changes in the graph theory indexes as measured via EEG
Time frame: 2 months
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.
12 secondary outcomes
Physical capacity (mobility)
Time frame: 2 months
Change in physical capacity (gait and balance, fall risk)
Time frame: 2 months
Body Weight index
Time frame: 2 months
Fitness
Time frame: 2 months
Physical capacity (balance & mobility)
Time frame: 2 months
Physical capacity (Functional mobility)
Time frame: 2 months
Quality of life index
Time frame: 2 months
Depression
Time frame: 2 months
Physical capacity (general)
Time frame: 2 months
Cognitive capacity (functional)
Time frame: 2 months
Cognitive capacity (Visuospatial attention)
Time frame: 2 months
Cognitive capacity
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 22 Jul 2021.
- 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.
- 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.
Panagiotis D bamidis, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing webFitForAll and BrainHQ in people with Parkinson Disease, 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 9 inclusion and 9 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 22 Jul 2021. 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?
Change in current density strength of the cortical activity as measured via EEG. (time frame: 2 months). The study lists 3 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 NCT04426903, which also lists 3 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 22 Jul 2021.