Gait Characteristics and Cognitive Evolution in Parkinson Disease (GECO-PD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson's Disease

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

• Study Contact: Name: Dario Alimonti, MD, PhD; Phone Number: +39 035-2673367; Email: dalimonti@asst-pg23.it
• Study Contact Backup: Name: Rosalia Zangari, PhD; Phone Number: +39 0352675134; Email: rzangari@fondazionefrom.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • ASST- Papa Giovanni XXIII
  • Brescia, Italy, 25123
    • Spedali Civili di Brescia
  • Monza, Italy, 20900
    • Ospedale San Gerardo di Monza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Parkinson's Disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 9, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: gait; device; attention/executive function domain; walk parameters; wireless inertial sensor
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: GECO-PARKINSON STUDY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No