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

Parkinson Disease Clinical Trial

— FREEDOM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830253
• Other study ID #: 2574CE
• Status: Recruiting
• Start date: September 8, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Beatrice De Maria
• Phone: 0250725286
• Email: beatrice.demaria[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Italy	Istituti Clinici Scientifici Maugeri	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA	Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Scale	Score ranges from 0 (no usability) to 100 (excellent usability)	1-2 weeks
Secondary	Movement Disordered Society - Unified Parkinson's Disease Rating Scale	Parkinson's Disease prognosis information. Score ranges from 0 (normal) to 199 (severe impairment).	Baseline
Secondary	Execution handwriting time	Time required to complete the handwriting task measured by the smart ink pen, in seconds	Baseline
Secondary	Execution handwriting time	Time required to complete the handwriting task measured by the smart ink pen, in seconds	1-2 weeks
Secondary	Average handwriting force	The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units	Baseline
Secondary	Average handwriting force	The average exerted force during handwriting task measured by the smart ink pen, in arbitrary units	1-2 weeks
Secondary	Gait speed	Gait speed [cm/s] measured by sensorized insoles	Baseline
Secondary	Gait speed	Gait speed [cm/s] measured by sensorized insoles	1-2 weeks