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AzTrials

ParkinsonTechHealthPDNCT06755645

Transforming Parkinson's Care With Predictive Algorithms

An observational study of Parkinson, run by University Ramon Llull at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Lifestyle interventions can alleviate Parkinson's Disease (PD) symptoms and delay disease progression. The novelty of this project lies in the development of an innovative smart platform that utilizes artificial intelligence (AI) and predictive models to offer a groundbreaking solution that not only prevents disease… Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson
What is being tested?
Lifestyle intervention
How many people
200 participants
Where
1 siteSpain
Study dates
Sep 2026to Sep 2028
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients diagnosed with Parkinson's disease

Who may be able to join

  • Patients with Parkinson's disease

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site
  • Ramon Llull University

    Barcelona, 08022

    Joel Montane, PhD, joelmm@blanquerna.url.edu

Other trials in Spain

About this study

Official title: Revolutionizing Patient Care and Lifestyle Through Predictive Algorithms in Parkinson's Disease

Lifestyle interventions can alleviate Parkinson's Disease (PD) symptoms and delay disease progression. The novelty of this project lies in the development of an innovative smart platform that utilizes artificial intelligence (AI) and predictive models to offer a groundbreaking solution that not only prevents disease progression but also significantly improves the well-being of patients with PD. For this, the technological smart platform will encompass 50 clinical variables, and a comprehensive range of other 50 supplementary variables, validated in a database with more than 1500 patients. The smart platform will include a user-friendly interface with different user profiles and a scalable back end with AI-based monitoring and prediction modules. This will offer primary prevention, early detection, and ongoing monitoring by specialized medical professionals at home and in hospitals.

Read the detailed description

Parkinson's Disease (PD) is the second most prevalent neurodegenerative disorder and the most common disorder that affects motor coordination, affecting 2% of the population above 65 years old and 4% in the population above 80 years old. Patients diagnosed with PD suffer with severe motor and non-motor symptoms. Typical motor symptoms include resting tremor or rigidity, slowness in voluntary movements called bradykinesia, difficulty in pronunciation when speaking, while non-motor symptoms could be sleep, cognitive and autonomic function disorders. PD not only disrupts motor function but also significantly influences the quality of life, sleep patterns, cognitive aspects, and mood of those living with the condition. While there is no cure for PD, certain treatments such as medication, surgery, and interdisciplinary approaches can effectively address and manage PD-associated symptoms. Given the diversity of treatments and the diverse impact of motor and non-motor symptoms on daily functioning, there's a growing need for more comprehensive interventions. Numerous studies have explored the impact of lifestyle interventions, such as physical activity (PA) on various aspects of PD, suggesting that patients with PD might benefit from PA in a number of ways, from general improvements in health to disease-specific effects and potentially, disease-modifying outcomes. To this aim, we conducted a randomized double-blind clinical trial conducted to study the effects of PA on mitochondrial function in skin fibroblasts in patients with PD (NCT05963425). This was an intervention study, with twenty-four patients, that were randomly assigned into three groups (8 patients/group). The first group performed basic physical training (BPT) based on strength and resistance, the second group performed BPT combined with functional exercises (BPTFE) with cognitive and motor training, and the third group did not carry out any activity program, serving as control. The PA interventions lasted 60 minutes, with a frequency of 3 times a week, during 16 weeks. The main objective was to assess the effects of PA on mitochondrial function, and its effects on a wide variety of clinical factors, such as motor function, quality of life, sleep, cognitive aspects, and mood.

Building on the holistic insights from the previous study, this project sets out to create a technological smart platform, utilizing artificial intelligence (AI), to foster healthy habits and optimal clinical management among PD population. Technological platforms emerge as instrumental tools in transforming the landscape of PD management. These platforms can facilitate continuous monitoring and tailored interventions that integrate, for example, lifestyle-embedded exercise programs. However, while technological interventions have shown promise in promoting healthy habits, there is limited research on the integration of AI for personalized interventions in the context of PD. Models developed to date have several key limitations including use of only one single feature (i.e. motor symptoms), model assumptions that patients follow a fixed progression, or not accounting for both positive and negative effects of symptomatic therapies for PD. Herein, we address the current limitations and propose a holistic approach based on an AI model that provides professionals, patients and carers with a smart platform capable of promoting healthy habits and optimizing clinical aspects. Herein, we recognize the importance of PA along with other healthy habits for PD patients by incorporating more than 50 other variables from the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a comprehensive clinical tool used to assess both motor and non-motor symptoms in PD patients, divided into four parts that evaluate daily living experiences, motor examination, and therapy-related motor complications. Importantly, the data collected will be validated with the Parkinson's Progression Markers Initiative (PPMI), a landmark study with more than 1500 patients designed to identify biomarkers of PD progression, enhancing the reliability and applicability of our findings. The successful execution of this project will culminate in an integrated solution that combines web and mobile interfaces, enhancing the overall accessibility and effectiveness of PD diagnostic and monitoring capabilities. The proposed AI-based smart platform has significant social implications, primarily in improving the quality of life for PD patients by addressing both motor and non-motor symptoms. It fosters a more comprehensive and personalized approach to PD management, moving beyond the limitations of current treatment methods, which often focus on singular aspects of the disease. By incorporating a wide range of variables from a well-established clinical database, the platform aims to deliver tailored interventions that promote healthy habits and optimize clinical outcomes. Additionally, the platform's use of AI for continuous monitoring and adaptive interventions will empower patients and caregivers, providing real-time support and reducing the burden on healthcare systems. This represents a shift towards more patient-centered, proactive care, potentially improving disease progression management and quality of life for the aging population affected by PD. In conclusion, the comprehensive approach seeks to provide valuable insights into PD progression and support the implementation of healthy habits in clinical practice.

Conditions
Parkinson
Being tested
Lifestyle intervention
Keywords
healthy habits, physical activity, artificial intelligence, smart platform
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle interventionOther

    A technological smart platform (app) that integrates diets, physical activity programs, sleep habits and other lifestyle interventions

Study groups in NCT06755645
Study groupRoleWhat they receive
Lifestyle intervention appThe group of patients includes individuals diagnosed with Parkinson's Disease (PD). This cohort encompasses a range of disease stages, severities, and demographic characteristics.
Receives: Other: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    The MDS-UPDRS was developed to evaluate various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. The MDS-UPDRS has a total score range of 0 to 236, with individual parts scoring between 0 to 52 (Parts I and II), 0 to 108 (Part III), and 0 to 24 (Part IV), assessing both motor and non-motor aspects of Parkinson's disease. A higher score indicates greater severity of Parkinson's disease symptoms.

    Measured: From enrollment (app download) to 1 year

Secondary outcomes (1)
  1. Montreal Cognitive Assessment (MoCA)

    The MoCA (Montreal Cognitive Assessment) scale has a total score range of 0 to 30, with higher scores indicating better cognitive function, and it assesses various cognitive domains such as memory, attention, language, and executive functions.

    Measured: At enrollment (app download) and after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2025
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06755645
Sponsor's protocol ID
TechHealthPD
Acronym
TechHealthPD
Status last verified
Nov 2025
First submitted
23 Dec 2024
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Magana JC, Deus CM, Baldellou L, Avellanet M, Gea-Rodriguez E, Enriquez-Calzada S, Laguna A, Martinez-Vicente M, Hernandez-Vara J, Gine-Garriga M, Pereira SP, Montane J. Investigating the impact of physical activity on mitochondrial function in Parkinson's disease (PARKEX): Study protocol for A randomized controlled clinical trial. PLoS One. 2023 Nov 22;18(11):e0293774. doi: 10.1371/journal.pone.0293774. eCollection 2023.

    PubMed 37992028
  • Jossa-Bastidas O, Zahia S, Fuente-Vidal A, Sanchez Ferez N, Roda Noguera O, Montane J, Garcia-Zapirain B. Predicting Physical Exercise Adherence in Fitness Apps Using a Deep Learning Approach. Int J Environ Res Public Health. 2021 Oct 14;18(20):10769. doi: 10.3390/ijerph182010769.

    PubMed 34682515

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson, run by University Ramon Llull at 1 site in Spain.

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 1 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: opening soon, as of the sponsor's last update on 1 Dec 2025. 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 Spain. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joel Montane, PhD (0034932533256, joelmm@blanquerna.url.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: From enrollment (app download) to 1 year). 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 NCT06755645, which also lists 2 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 1 Dec 2025.

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