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

NCT05830253 | Completed

• 1 other identifier: 2574CE
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• System Usability Scale

  Score ranges from 0 (no usability) to 100 (excellent usability)

  1-2 weeks

Secondary Outcomes (7)

• Movement Disordered Society - Unified Parkinson's Disease Rating Scale

  Baseline

• Execution handwriting time

  Baseline

• Execution handwriting time

  1-2 weeks

• Average handwriting force

  Baseline

• Average handwriting force

  1-2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Parkinson's disease

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Milan, 20138, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 26, 2023
• Study Start: September 8, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)