Gait Characteristics and Cognitive Evolution in Parkinson Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Gait Characteristics and Cognitive Evolution in Parkinson Disease (GECO-PARKINSON STUDY)

Conditions
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Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both sex Aged between 55-74 years Diagnosis of idiopathic PD based on MDS clinical diagnostic criteria Hoehn & Yahr (H&Y) stages 2 to 3 at enrollment, independently by PD duration Clinical-pharmacological stabilization until 3 months before the enrollment DBS treatment (stable stimulation parameters until 6 months before the enrollment) Exclusion Criteria: Evidence of neurodegenerative and secondary parkinsonism Dementia ( (score <25 on the Mini Mental State Examination - MMSE) Psychiatric disorder (Beck Depression Inventory-II - BDI-II Score >19) Presence of organ failure (Modified Cumulative Illness Rating Scale - CIRS > 2) Orthopedic disorder or co-morbidities that may affect gait Drug and alcohol use

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gait assessed by 6-Minute Walk Test (6MWT) | Gait assessment | Every 6 months for 3 years | 
| Changes in Gait assessed by Extended-Time Up and Go (eTUG) | Gait assessment | Every 6 months 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 6 months 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 6 months for 3 years | 
| Changes in cognitive function assessed by Frontal Assessment Battery (FAB) | Cognitive Assessment | Every 6 months for 3 years | 

Secondary Outcome Measures

| Outcome Measure | 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 6 months 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. | Every 6 months for 3 years | 
| Hyposmia Rating Scale | The scale ranges from 6 to 24, where higer scores indicate more worse sense of olfaction. | Every 6 months for 3 years | 
| Beck Depression Inventory II | The BDI-II ranges from 0 to 63, where higer scores indicate more severe depressive symptoms. | Every 6 months for 3 years | 
| Beck Anxiety Index | The BAI range is 0- 63, where higer scores indicate more severe symptoms. | Every 6 months 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 6 months 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 6 months 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 6 months 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 6 months for 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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device, gait, attention/executive function domain, walk parameters, wireless inertial sensor