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Clinical Trials/NCT05349539
NCT05349539
Recruiting
N/A

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

Neuromed IRCCS1 site in 1 country50 target enrollmentJune 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Neuromed IRCCS
Enrollment
50
Locations
1
Primary Endpoint
Time of OFF state of therapy during daily activity hours;
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
December 21, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Neuromed IRCCS
Responsible Party
Principal Investigator
Principal Investigator

Antonio Suppa

Principal Investigator

Neuromed IRCCS

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.

Outcomes

Primary Outcomes

Time of OFF state of therapy during daily activity hours;

Time Frame: 24 hours

Time spent with poor motor control despite optimized pharmacological therapy

Number of "Wearing Off" and "ON-OFF" phenomena

Time Frame: 24 hours

Number of motor complications despite optimized pharmacological therapy

Number of "freezing of gait" episodes

Time Frame: 24 hours

Number of paroxysmal gait disorders despite optimized pharmacological therapy

Study Sites (1)

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