Gait Characteristics and Cognitive Evolution in Parkinson Disease

  • STATUS
    Recruiting
  • End date
    Nov 17, 2023
  • participants needed
    60
  • sponsor
    Fondazione per la Ricerca Ospedale Maggiore
Updated on 17 June 2021
cognitive impairment
motor symptoms
nervous system disorder

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.

Details
Condition parkinson's, parkinson disease, Parkinson's disease
Clinical Study IdentifierNCT04297800
SponsorFondazione per la Ricerca Ospedale Maggiore
Last Modified on17 June 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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