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Sponsor study identifier
observational
200
1 country
1
Study Start
March 1, 2021
Actual (reported)Primary Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2020
Actual (reported)February 28, 2020
Actual (reported)March 1, 2021
Actual (reported)June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Falls
Number of alls measured with wearable sensors
Continuously over 12 months
Physical activity
Minutes of physical activity performed during daily-life measured with wearable sensors
Continuously over 12 months
Physical activity
Twice - baseline and after 12 months
Walking capacity
Once - baseline
Falls
Twice - baseline and after 12 months
Functional lower extremity strength
Once - baseline
Fear of falling
Twice - baseline and after 12 months
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).
Radboud university medical center
Nijmegen, Netherlands
Nienke M de Vries, Dr
Radboud University Medical Center
200 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2020
First Posted
February 28, 2020
Study Start
March 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 4, 2023
Record last verified: 2022-10
All data will be anonymized. The wearable sensor data will not be available for re-use and/or sharing.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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