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.
Study Type
OBSERVATIONAL
Enrollment
60
ASST- Papa Giovanni XXIII
Bergamo, Italy
Spedali Civili di Brescia
Brescia, Italy
Ospedale San Gerardo di Monza
Monza, Italy
Changes in Gait assessed by 6-Minute Walk Test (6MWT)
Gait assessment
Time frame: Every year for 3 years
Changes in Gait assessed by Extended-Time Up and Go (eTUG)
Gait assessment
Time frame: Every year for 3 years
Changes in cognitive function assessed by Mini-Mental State Examination (MMSE)
Cognitive Assessment. The MMSE score ranges from 0 to 30 points, in which a lower score indicates a higher degree of cognitive impairment.
Time frame: Every year for 3 years
Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Cognitive Assessment. The total score of the MoCA is 30 points, with a score less than 24 is considered cognitive impairment.
Time frame: Every year for 3 years
Changes in cognitive function assessed by Frontal Assessment Battery (FAB)
Cognitive Assessment
Time frame: Every year for 3 years
Movement Disorder Society-Unified Parkinson's Disease Rating Scale, part III
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson\'s disease motor symptoms on a scale from 0 to 4 points. The total scale range is 0-132, where higher scores indicate more severe symptoms.
Time frame: Every year for 3 years
"Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire
The RBDSQ ranges from 0 to 13, where higher scores represent a worse outcome.
Time frame: Every year for 3 years
Hyposmia Rating Scale
The scale ranges from 6 to 24, where higer scores indicate more worse sense of olfaction.
Time frame: Every year for 3 years
short Falls Efficacy Scale
s-FES ranges from 7 to 28, where higher scores indicate high level of concern about falling during social and physical activities inside and outside the home.
Time frame: Every year for 3 years
Berg Balance Scale
The BBC includes 14 functional balance. The scale ranges from 0 to 56, where higer scores indicate that the participant can complete the tasks.
Time frame: Every year for 3 years
Tinetti test
The test grants a maximum of 16 points for static part (sitting) and 12 point for dynamic (walking) part. Higher is the score, better is the performance
Time frame: Every year for 3 years
Parkinson's Disease Questionnaire
PDQ-8 ranges from 0 to 32, where higher scores reflect a lower health-related quality of life.
Time frame: Every year for 3 years
Beck Anxiety Index
The BAI range is 0- 63, where higer scores indicate more severe symptoms.
Time frame: Every year for 3 years
Beck Depression Inventory II
The BDI-II ranges from 0 to 63, where higer scores indicate more severe depressive symptoms.
Time frame: Every year for 3 years
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