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Clinical Trials/NCT05830253
NCT05830253
Completed
Not Applicable

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

Istituti Clinici Scientifici Maugeri SpA1 site in 1 country30 target enrollmentSeptember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Enrollment
30
Locations
1
Primary Endpoint
System Usability Scale
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2021
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

System Usability Scale

Time Frame: 1-2 weeks

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

Secondary Outcomes

  • Movement Disordered Society - Unified Parkinson's Disease Rating Scale(Baseline)
  • Execution handwriting time(1-2 weeks)
  • Gait speed(1-2 weeks)
  • Average handwriting force(1-2 weeks)

Study Sites (1)

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