Gait Characteristics and Cognitive Evolution in Parkinson Disease

NCT ID: NCT04297800

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-09
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dario Alimonti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ASST- Papa Giovanni XXIII

Francesco Biroli, MD

Role: STUDY_CHAIR

Fondazione per la Ricerca Ospedale di Bergamo (FROM)

Locations

ASST- Papa Giovanni XXIII

Bergamo, , Italy

Spedali Civili di Brescia

Brescia, , Italy

Ospedale San Gerardo di Monza

Monza, , Italy

Countries

Italy

Other Identifiers

GECO-PARKINSON STUDY

Identifier Type: -

Identifier Source: org_study_id