Gait Characteristics and Cognitive Evolution in Parkinson Disease

Parkinson's Disease Clinical Trial

— GECO-PD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04297800
• Other study ID #: GECO-PARKINSON STUDY
• Status: Active, not recruiting
• Start date: November 9, 2019
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Fondazione per la Ricerca Ospedale Maggiore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Italy	ASST- Papa Giovanni XXIII	Bergamo
Italy	Spedali Civili di Brescia	Brescia
Italy	Ospedale San Gerardo di Monza	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione per la Ricerca Ospedale Maggiore

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gait assessed by 6-Minute Walk Test (6MWT)	Gait assessment	Every 6 months for 3 years
Primary	Changes in Gait assessed by Extended-Time Up and Go (eTUG)	Gait assessment	Every 6 months for 3 years
Primary	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
Primary	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
Primary	Changes in cognitive function assessed by Frontal Assessment Battery (FAB)	Cognitive Assessment	Every 6 months for 3 years
Secondary	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
Secondary	"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
Secondary	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
Secondary	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
Secondary	Beck Anxiety Index	The BAI range is 0- 63, where higer scores indicate more severe symptoms.	Every 6 months for 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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