Istituti Clinici Scientifici Maugeri
Milan, 20138, Italy
NCT Number: NCT05830253
Parkinson's disease, one of the most common neurodegenerative diseases of the central nervous system, presents motor symptoms, including tremor, rigidity, bradykinesia, and postural instability. Assessments of patients with Parkinson's disease are typically performed using clinical scales, compiled by the healthcare staff or by the patient. Although commonly used in clinical practice, they have some limitations, including the low temporal resolution of the scales, the low granularity of the scores and the possible low inter- and intra-operator reliability. The recent development of digital technologies has led to the creation of IoT (Internet of Things) devices capable of providing quantitative indicators, potentially useful for an accurate differential diagnosis, as well as for monitoring the effects of therapeutic interventions. The peculiarity of these systems is the ability to provide indicators not only during periodic visits to the clinic, but also the ability to remotely monitor the patient's daily life activities. In this scenario, this study wants to test the hypothesis that the IoT devices like smart-ink pens and insoles are usable options for monitoring patients with Parkinson's disease.
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Notify Me18 year and older
All sexes
Observational
Milan, 20138, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1-2 weeks
Score ranges from 0 (no usability) to 100 (excellent usability)
Time frame: Baseline
Parkinson's Disease prognosis information. Score ranges from 0 (normal) to 199 (severe impairment).
Time frame: Baseline
Time required to complete the handwriting task measured by the smart ink pen, in seconds
Time frame: 1-2 weeks
Time required to complete the handwriting task measured by the smart ink pen, in seconds
Time frame: Baseline
The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units
Time frame: 1-2 weeks
The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units
Time frame: Baseline
Gait speed [cm/s] measured by sensorized insoles
Time frame: 1-2 weeks
Gait speed [cm/s] measured by sensorized insoles
Istituti Clinici Scientifici Maugeri SpA
Other
Free-living Monitoring of Parkinson's Disease Using Smart Objects: Towards Digital Medicine
Acronym: FREEDOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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