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

February 19, 2025 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20138
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale
Time Frame: 1-2 weeks
Score ranges from 0 (no usability) to 100 (excellent usability)
1-2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2574CE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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