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Free-living Monitoring of Parkinson's Disease Using Smart Objects

Free-living Monitoring of Parkinson's Disease Using Smart Objects: Towards Digital Medicine

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05830253
Acronym
FREEDOM
Enrollment
30
Registered
2023-04-26
Start date
2021-09-08
Completion date
2024-12-31
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

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.

Interventions

None listed

Sponsors

Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
CollaboratorOTHER
Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult individuls * Cognitive impairments * Ability to independently sign the written informed consent

Exclusion criteria

* Unstable pharmacological treatment for Parkinson's Disease during the study * Previous history of major neurological, vascular, musculoskeletal disorders

Design outcomes

Primary

MeasureTime frameDescription
System Usability Scale1-2 weeksScore ranges from 0 (no usability) to 100 (excellent usability)

Secondary

MeasureTime frameDescription
Movement Disordered Society - Unified Parkinson's Disease Rating ScaleBaselineParkinson's Disease prognosis information. Score ranges from 0 (normal) to 199 (severe impairment).
Execution handwriting timeBaselineTime required to complete the handwriting task measured by the smart ink pen, in seconds
Average handwriting forceBaselineThe average exerted force during handwriting task measured by the smart ink pen, in arbitrary units
Gait speedBaselineGait speed \[cm/s\] measured by sensorized insoles

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026