Parkinson Disease Clinical Trial
Official title:
Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease
NCT number | NCT05349539 |
Other study ID # | NEUR_05 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | December 21, 2023 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCSS Neuromed | Pozzilli |
Lead Sponsor | Collaborator |
---|---|
Neuromed IRCCS |
Italy,
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 |
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