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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT05830253
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-08
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-26
• Status Verified: 2024-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System Usability Scale	1-2 weeks	Score ranges from 0 (no usability) to 100 (excellent usability)

Secondary Outcome Measures

Name	Time	Method
Gait speed	1-2 weeks	Gait speed \[cm/s\] measured by sensorized insoles
Movement Disordered Society - Unified Parkinson's Disease Rating Scale	Baseline	Parkinson's Disease prognosis information. Score ranges from 0 (normal) to 199 (severe impairment).
Average handwriting force	1-2 weeks	The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units
Execution handwriting time	1-2 weeks	Time required to complete the handwriting task measured by the smart ink pen, in seconds

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri; 🇮🇹 Milan, Italy