AzTrials
AzTrials

Parkinson DiseaseNCT04288583

Bringing Parkinson Care Back Home

An observational study of Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

SUMMARY Rationale: For persons with Parkinson's disease (PD), medical decisions are based almost exclusively on periodic in-clinic evaluations by a neurologist or a nurse. For a variety of reasons, such "snapshots" are unable to capture the actual impact of PD on the patient's functioning in their own home… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Parkinson Disease
How many people
200 participants
Where
1 siteNetherlands
Study dates
1 Mar 2021to 30 Jun 2023
Phase
Observational
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 200 patients diagnosed with Parkinson's disease with an increased fall risk (i.e. who reported at least one fall in the last 6 months).

Who may be able to join

  • Subjects must confirm that they have been diagnosed with Parkinson's Disease by a neurologist (self-reported)
  • Age 18 or older
  • At least 1 fall incident in the previous 6 months. A fall is defined as any unexpected event that caused the person to unintentionally land on any lower surface (object, floor, or ground), regardless of any sustained injury (self-reported)
  • Able and willing to provide written informed consent in accordance with Good Clinical Practice, and national and local regulation
  • Fluent in Dutch

Who cannot join

  • The patients receives advanced therapy for their Parkinson's disease (deep brain stimulation, duodopa pump, apomorphine pump);
  • The patients shows cognitive of psychiatric impairments that may hinder successful completion of the study protocol (as judged by the researcher running the recruitment).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud university medical center

    Nijmegen

Other trials in Netherlands

About this study

SUMMARY

Rationale: For persons with Parkinson's disease (PD), medical decisions are based almost exclusively on periodic in-clinic evaluations by a neurologist or a nurse. For a variety of reasons, such "snapshots" are unable to capture the actual impact of PD on the patient's functioning in their own home environment. Outpatient evaluations cannot detect rare and typically domestic events, such as falls. In addition, episodic visits are not well suited to detect changes in important lifestyle issues, such as gradual declines in physical activity.

Read more

Objective: To objectively, continuously and accurately collect detailed information on (changes in) physical activity and fall patterns among patients with PD in daily life.

Study design: Observational cohort study in 200 patients with PD, with a 12 month follow-up period.

Study population: Patients with PD (n=200), with an increased fall risk (i.e. at least one fall within the last six months).

Intervention (if applicable): This study does not include an intervention. After a baseline assessment on demographics and PD symptoms, patients will use a remote monitoring system at home (a pendant falls detector) combined with an smartphone application aimed at falls self-reporting, and an application to report medication intake for 12 months. A similar set up (i.e.Vital@Home) has been previously tested on feasibility (Dossiernummer: 2017-3382). Additionally, patients will report sleep patterns through paper-based diaries.

Main study parameters/endpoints: The main study parameters are physical activity and number of falls. They are remotely registered by the pendant falls detector.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no invasive measurements will be performed. The participation is free of risks. Subjects could potentially benefit personally from participating in this study, as they can use the devices for free during the study and receive periodically feedback about physical activity and the occurrence of falls.

Keywords
Wearable sensors, Falls, Physical activity, Parkinson's disease
Medical subject headings
Parkinson Disease, Motor Activity

What is being measured

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

  1. Falls

    Number of alls measured with wearable sensors

    Measured: Continuously over 12 months

  2. Physical activity

    Minutes of physical activity performed during daily-life measured with wearable sensors

    Measured: Continuously over 12 months

Secondary outcomes (17)

  1. Physical activity

    LASA physical activity questionnaire, in which the higher the score the better

    Measured: Twice - baseline and after 12 months

  2. Walking capacity

    6-meter walking test, in which the higher the distance walked the better

    Measured: Once - baseline

  3. Falls

    Falls history questionnaire

    Measured: Twice - baseline and after 12 months

  4. Functional lower extremity strength

    Five-times-sit-to-stand, in which the faster the task is completed the better

    Measured: Once - baseline

  5. Fear of falling

    Falls Efficacy Scale International, with scores ranging from 16 to 64 points, in which the a higher score indicates worse fear of falling

    Measured: Twice - baseline and after 12 months

  6. Compliance

    Number of days in which participants worn the device for more than 8 hours

    Measured: Continuously over 12 months

  7. Patients demographics

    Demographics questionnaire (age, gender, education, disease duration)

    Measured: Once - baseline

  8. Disease severity

    Movement Disorders Society - Unified Parkinson's Disease Rating Scale part I-IV, with scores ranging from 0 to 272, in which the higher the score the worse symptoms are.

    Measured: Part III - once at baseline. Part I, II and IV - twice baseline and after 12 months

  9. Disease status

    Hoehn \& Yahr stadia, ranging from 0-5, in which the higher the worse the disease status is.

    Measured: Once - baseline

  10. Medication

    Medication intake diary

    Measured: Continuously over 12 months

  11. Balance - I

    Mini-BESTest, ranging from 0 to 28, in which the higher the score the better the balance

    Measured: Once - baseline

  12. Balance - II

    Single leg stance test

    Measured: Once - baseline

  13. Freezing of gait - I

    New freezing of gait questionnaire, ranging from 0 to 24, in which the higher the score the worse is the freezing of gait.

    Measured: Twice - baseline and after 12 months

  14. Freezing of gait - II

    Rapid turns test

    Measured: Once - baseline

  15. Cognition

    Montreal Cognitive Assessment, with scores ranging from 0 to 30, in which the higher the better the cognition.

    Measured: Once - baseline

  16. Sleep quality

    Pittsburgh Sleep Quality Index, with scores ranging from 0 to 21, in which the higher the worse the sleep quality.

    Measured: Twice - baseline and after 12 months

  17. Sleep quality and quantity

    Sleep diary

    Measured: Once for a full week

Timeline

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

  1. First posted28 Feb 2020
  2. Study start1 Mar 2021
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (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
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04288583
Sponsor's protocol ID
2019-5845
Status last verified
Oct 2022
First submitted
26 Feb 2020
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be anonymized. The wearable sensor data will not be available for re-use and/or sharing.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.

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 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 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 Netherlands. 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?

Results are not available in the source record.

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?

Falls (time frame: Continuously over 12 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 NCT04288583.

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 4 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in