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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05349539

Enrollment

Registered

2022-04-27

Start date

2022-06-01

Completion date

2023-12-21

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Motor Disorders, Parkinson Disease

Keywords

Parkinson's disease, Wearable sensors

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactAntonio Suppa, MD, PhD

antonio.suppa@uniroma1.it3494940365

Outcome results