Status:
COMPLETED
Gait Characteristics and Cognitive Evolution in Parkinson Disease
Lead Sponsor:
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Conditions:
Parkinson's Disease
Eligibility:
All Genders
55-74 years
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 impa...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04297800
Start Date
November 9 2019
End Date
December 31 2024
Last Update
January 8 2025
Active Locations (3)
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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