Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease

NCT ID: NCT05349539

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-12-21

Brief Summary

The clinical management of Parkinson's disease (PD) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the ON-OFF phenomenon, primarily manifesting at home. Therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including "recall bias" and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. In the last two decades, new wearable technologies, consisting of "wireless" sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). The aim of this study is to evaluate motor symptoms in patients with PD, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.

Conditions

Parkinson Disease; Motor Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Subjects

Cohort of healthy subjects as control.

No interventions assigned to this group

Patients with Parkinson's disease

Cohort of patients with Parkinson's disease

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• diagnosis of idiopathic Parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations;
• ability to walk independently

Exclusion Criteria

• dementia (MMSE < 24/30);
• comorbidities affecting gait (e.g., rheumatological or orthopedic issues);
• atypical parkinsonism.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuromed IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Antonio Suppa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCSS Neuromed

Pozzilli, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Suppa, MD, PhD

Role: CONTACT

antonio.suppa@uniroma1.it

3494940365 ext. +0039

Facility Contacts

Antonio Suppa, MD

Role: primary

Other Identifiers

NEUR_05

Identifier Type: -

Identifier Source: org_study_id