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OpenTrials
Completed

NCT Number: NCT05830253

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituti Clinici Scientifici Maugeri

Milan, 20138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. System Usability Scale

    Time frame: 1-2 weeks

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

Secondary outcomes

  1. 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).

  2. Execution handwriting time

    Time frame: Baseline

    Time required to complete the handwriting task measured by the smart ink pen, in seconds

  3. Execution handwriting time

    Time frame: 1-2 weeks

    Time required to complete the handwriting task measured by the smart ink pen, in seconds

  4. Average handwriting force

    Time frame: Baseline

    The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units

  5. Average handwriting force

    Time frame: 1-2 weeks

    The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units

  6. Gait speed

    Time frame: Baseline

    Gait speed [cm/s] measured by sensorized insoles

  7. Gait speed

    Time frame: 1-2 weeks

    Gait speed [cm/s] measured by sensorized insoles

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FREEDOM

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2023
Registry last updated
Feb 20, 2025

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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