Clinical trial NCT04297800: Gait Characteristics and Cognitive Evolution in Parkinson Disease
Official title: Gait Characteristics and Cognitive Evolution in Parkinson Disease (GECO-PARKINSON STUDY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: gait
attention/executive function domain
device
walk parameters
wireless inertial sensor
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's Disease

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.

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

Primary outcomes:
measure: Changes in Gait assessed by 6-Minute Walk Test (6MWT)
timeFrame: Every year for 3 years
measure: Changes in Gait assessed by Extended-Time Up and Go (eTUG)
timeFrame: Every year for 3 years
measure: Changes in cognitive function assessed by Mini-Mental State Examination (MMSE)
timeFrame: Every year for 3 years
measure: Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
timeFrame: Every year for 3 years
measure: Changes in cognitive function assessed by Frontal Assessment Battery (FAB)
timeFrame: Every year for 3 years
Secondary outcomes:
measure: Movement Disorder Society-Unified Parkinson&#39;s Disease Rating Scale, part III
timeFrame: Every year for 3 years
measure: &#34;Rapid eye movement Sleep&#34; Behavior Disorder Screening Questionnaire
timeFrame: Every year for 3 years
measure: Hyposmia Rating Scale
timeFrame: Every year for 3 years
measure: short Falls Efficacy Scale
timeFrame: Every year for 3 years
measure: Berg Balance Scale
timeFrame: Every year for 3 years
measure: Tinetti test
timeFrame: Every year for 3 years
measure: Parkinson's Disease Questionnaire
timeFrame: Every year for 3 years
measure: Beck Anxiety Index
timeFrame: Every year for 3 years
measure: Beck Depression Inventory II
timeFrame: Every year for 3 years
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST- Papa Giovanni XXIII
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Monza
country: Italy
facility: Ospedale San Gerardo di Monza
Study officials:
affiliation: ASST- Papa Giovanni XXIII
name: Dario Alimonti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione per la Ricerca Ospedale di Bergamo (FROM)
name: Francesco Biroli, MD
role: STUDY_CHAIR
References: