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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05349539
• Other study ID #: NEUR_05
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 21, 2023

Study information

• Verified date: March 2023
• Source: Neuromed IRCCS
• Contact: Antonio Suppa, MD, PhD
• Phone: 3494940365
• Email: antonio.suppa[@]uniroma1.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 21, 2023
• Est. primary completion date: December 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Motor Disorders
• Parkinson Disease

Locations

Country	Name	City	State
Italy	IRCSS Neuromed	Pozzilli

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of OFF state of therapy during daily activity hours;	Time spent with poor motor control despite optimized pharmacological therapy	24 hours
Primary	Number of "Wearing Off" and "ON-OFF" phenomena	Number of motor complications despite optimized pharmacological therapy	24 hours
Primary	Number of "freezing of gait" episodes	Number of paroxysmal gait disorders despite optimized pharmacological therapy	24 hours