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

Recruiting

• Conditions: Parkinson Disease; Motor Disorders

• Registration Number: NCT05349539
• Lead Sponsor: Neuromed IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-06-01
• Primary Completion: 2022-12-21
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of OFF state of therapy during daily activity hours;	24 hours	Time spent with poor motor control despite optimized pharmacological therapy
Number of "Wearing Off" and "ON-OFF" phenomena	24 hours	Number of motor complications despite optimized pharmacological therapy
Number of "freezing of gait" episodes	24 hours	Number of paroxysmal gait disorders despite optimized pharmacological therapy

Trial Locations

Locations (1)

IRCSS Neuromed; 🇮🇹 Pozzilli, Italy