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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gait assessed by 6-Minute Walk Test (6MWT) | Gait assessment | Every year for 3 years |
| Changes in Gait assessed by Extended-Time Up and Go (eTUG) | Gait assessment | 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. | 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. | Every year for 3 years |
| Changes in cognitive function assessed by Frontal Assessment Battery (FAB) | Cognitive Assessment | Every year for 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every year for 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Parkinson's Disease
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| Name | Affiliation | Role |
|---|---|---|
| Dario Alimonti, MD, PhD | ASST- Papa Giovanni XXIII | Principal Investigator |
| Francesco Biroli, MD | Fondazione per la Ricerca Ospedale di Bergamo (FROM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST- Papa Giovanni XXIII | Bergamo | 24127 | Italy | |||
| Spedali Civili di Brescia |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| "Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire |
The RBDSQ ranges from 0 to 13, where higher scores represent a worse outcome. |
| Every year for 3 years |
| Hyposmia Rating Scale | The scale ranges from 6 to 24, where higer scores indicate more worse sense of olfaction. | 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. | 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. | 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 | 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. | Every year for 3 years |
| Beck Anxiety Index | The BAI range is 0- 63, where higer scores indicate more severe symptoms. | 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. | Every year for 3 years |
| Brescia |
| 25123 |
| Italy |
| Ospedale San Gerardo di Monza | Monza | 20900 | Italy |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |