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

Sponsor

Neuromed IRCCS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05349539

Collaborator

(none)

Enrollment

6.7

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Motor Disorders

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 21, 2022

Anticipated Study Completion Date :

Dec 21, 2022

Arms and Interventions

Arm	Intervention/Treatment
Healthy Subjects Cohort of healthy subjects as control.
Patients with Parkinson's disease Cohort of patients with Parkinson's disease

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Neuromed IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Suppa, Principal Investigator, Neuromed IRCCS

ClinicalTrials.gov Identifier:

NCT05349539

Other Study ID Numbers:

NEUR_05

First Posted:

Apr 27, 2022

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Antonio Suppa, Principal Investigator, Neuromed IRCCS

Parkinson's disease

Wearable sensors

Additional relevant MeSH terms:

Parkinson Disease

Motor Disorders

Study Results

No Results Posted as of May 4, 2022