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Smartwatches could read Parkinson's quality of life

NCT ID NCT06209502

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This observational study explores whether data from everyday smartwatches and smartphones can be used to remotely assess the health-related quality of life of people with Parkinson's disease. Researchers will develop an algorithm, called the Q-index, based on passively collected data from these devices. The study includes 95 participants with Parkinson's disease at various stages, aiming to see if this approach can monitor quality of life without frequent clinic visits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Wearable and portable devices (smartwatch and smartphone) with the Koios Care app
What this could lead to
If successful, this could enable remote, passive monitoring of quality of life in Parkinson's patients, potentially improving care and reducing clinic visits.
What could go wrong
This is an early proof-of-concept study with a small number of participants. The algorithm may not be accurate enough for clinical use, and results may not generalize to all Parkinson's patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

95 people

The number who actually took part.

Started

Nov 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The recruitment process for Parkinson's Disease patients begins during a consultation taking place in one of the three participating clinics. Specifically, a member of the medical team informs the patient about the ongoing study, including but not limited to, its goals, the technology, and the timeline of the study. The recruitment of a Parkinson's Disease patient also appears as an opportunity to recruit healthy participants. Specifically, the study targets members of the close circle of the patient, i.e., age-matched friends and close family members. It should be noted that to avoid recruitment bias (e.g., the partner of the patient stays home to support their patient partner), the partner of the patient is left as the emergency (low recruitment rate for healthy controls) recruitment scenario. In addition, the recruitment procedure for healthy controls will be supported by wall posters in the hospital campus and web advertising.

Ages

30 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females between the ages of 30 and 75 * Agree to download and install the Koios Care application to their personal Android smartphone. * People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease. o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met. * Score between one-and-a-half (1.5) and three (3) at the H\&Y rating scale in the "ON" state (population A) * Score of one (1) at the H\&Y rating scale in the "ON" state (population B) Exclusion Criteria: * The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level. * The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities). * The candidate is not an Android smartphone owner and user for at least six (6) months. * The candidate's Android smartphone is not compatible with the Koios Care application. * The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24. * The candidate has exhibited uncontrolled/extreme measures of depression as judged by the expert investigator, e.g., self-harm, suicide attempts or patient admitted to the hospital for a similar reason. \-- If the participant develops such behavior or s/he is admitted to the hospital for the above reasons during the study, then the candidate is immediately removed from the study. * Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AZ Delta, Department of Neurology, EC reference 23045

    Roeselare, 8800, Belgium

  • AZ Oostende, Department of Neurology, EC reference OG-057

    Ostend, Belgium

  • CHU Charleroi, Department of Neurology, EC reference AH/SG-2023-037

    Charleroi, Belgium

  • CHU de Liege, Department of Neurology, EC reference 2023/173

    Liège, Belgium

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