GECO-PD: Gait Characteristics and Cognitive Evolution in Parkinson Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
- Changes in Gait assessed by 6-Minute Walk Test (6MWT) [Every 6 months for 3 years]
Gait assessment
- Changes in Gait assessed by Extended-Time Up and Go (eTUG) [Every 6 months for 3 years]
Gait assessment
- Changes in cognitive function assessed by Mini-Mental State Examination (MMSE) [Every 6 months for 3 years]
Cognitive Assessment. The MMSE score ranges from 0 to 30 points, in which a lower score indicates a higher degree of cognitive impairment.
- Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA) [Every 6 months for 3 years]
Cognitive Assessment. The total score of the MoCA is 30 points, with a score less than 24 is considered cognitive impairment.
- Changes in cognitive function assessed by Frontal Assessment Battery (FAB) [Every 6 months for 3 years]
Cognitive Assessment
Secondary Outcome Measures
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale, part III [Every 6 months for 3 years]
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.
- "Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire [Every 6 months for 3 years]
The RBDSQ ranges from 0 to 13, where higher scores represent a worse outcome.
- Hyposmia Rating Scale [Every 6 months for 3 years]
The scale ranges from 6 to 24, where higer scores indicate more worse sense of olfaction.
- Beck Depression Inventory II [Every 6 months for 3 years]
The BDI-II ranges from 0 to 63, where higer scores indicate more severe depressive symptoms.
- Beck Anxiety Index [Every 6 months for 3 years]
The BAI range is 0- 63, where higer scores indicate more severe symptoms.
- Parkinson's Disease Questionnaire [Every 6 months for 3 years]
PDQ-8 ranges from 0 to 32, where higher scores reflect a lower health-related quality of life.
- Tinetti test [Every 6 months for 3 years]
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
- Berg Balance Scale [Every 6 months for 3 years]
The BBC includes 14 functional balance. The scale ranges from 0 to 56, where higer scores indicate that the participant can complete the tasks.
- short Falls Efficacy Scale [Every 6 months for 3 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Both sex
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Aged between 55-74 years
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Diagnosis of idiopathic PD based on MDS clinical diagnostic criteria
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Hoehn & Yahr (H&Y) stages 2 to 3 at enrollment, independently by PD duration
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Clinical-pharmacological stabilization until 3 months before the enrollment
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DBS treatment (stable stimulation parameters until 6 months before the enrollment)
Exclusion Criteria:
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Evidence of neurodegenerative and secondary parkinsonism
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Dementia ( (score <25 on the Mini Mental State Examination - MMSE)
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Psychiatric disorder (Beck Depression Inventory-II - BDI-II Score >19)
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Presence of organ failure (Modified Cumulative Illness Rating Scale - CIRS > 2)
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Orthopedic disorder or co-morbidities that may affect gait
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Drug and alcohol use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ASST- Papa Giovanni XXIII | Bergamo | Italy | 24127 | |
| 2 | Spedali Civili di Brescia | Brescia | Italy | 25123 | |
| 3 | Ospedale San Gerardo di Monza | Monza | Italy | 20900 |
Sponsors and Collaborators
- Fondazione per la Ricerca Ospedale Maggiore
Investigators
- Principal Investigator: Dario Alimonti, MD, PhD, ASST- Papa Giovanni XXIII
- Study Chair: Francesco Biroli, MD, Fondazione per la Ricerca Ospedale di Bergamo (FROM)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GECO-PARKINSON STUDY