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Gait Characteristics and Cognitive Evolution in Parkinson Disease (GECO-PARKINSON STUDY)
Parkinson's disease (PD) is a chronic progressive nervous system disease with gradual motor impairment. Cognitive dysfunction is common in PD, even in the early stages, and it is characterized by impairments in executive, attention, memory, language and visuospatial function. Motor symptoms, in particular, alterations in gait, have been studied in clinical practice to assess disease progression, and its response to treatments, both farmacological and physiotherapeutic. Recent research on wearable technology in PD has shown that motor tests can be automated using wearable technology to eliminate human supervision and patient-reported data. Particularly, the quantitative gait analysis by using inertial devices has been proposed as a sensitive tool to longitudinally monitor gait worsening, response to dopaminergic treatment over time and cognitive dysfunction in PD patients. The aim of this prospective multicente observational study is to investigate whether the dysfunction of specific gait parameters may be correlated to cognitive impairment (Attention/Executive Function Domain) in a cohort of ambulatory PD patients followed for 3 years.
This is a prospective multicenter observational study with annual follow-up assessments over 3 years. Gait is assessed by an inertial device (BTS G-WALK). G- WALK is an easy-to-use solution to obtain accurate, objective and quantitative spatial-temporal gait data. The device is a wireless system consisting of an inertial sensor composed by a triaxial accelerometer, a magnetic sensor, and a triaxial gyroscope that positioned on lumbar/ or sacral segments allows a functional gait analysis. Cognitive performance is evaluated with a neuropsychological battery designed to assess memory, executive /attention, and visuospatial domains.
Age
55 - 74 years
Sex
ALL
Healthy Volunteers
No
ASST- Papa Giovanni XXIII
Bergamo, Italy
Spedali Civili di Brescia
Brescia, Italy
Ospedale San Gerardo di Monza
Monza, Italy
Start Date
November 9, 2019
Primary Completion Date
November 30, 2023
Completion Date
December 31, 2024
Last Updated
January 8, 2025
60
ACTUAL participants
Lead Sponsor
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
NCT07310264
NCT02119611
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07216976