Gait Characteristics and Cognitive Evolution in Parkinson Disease

NCT04297800 | Completed

• 1 other identifier: GECO-PARKINSON STUDY
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson's Disease

Keywords

gait; attention/executive function domain; device; walk parameters; wireless inertial sensor

Outcome Measures

Primary Outcomes (5)

• Changes in Gait assessed by 6-Minute Walk Test (6MWT)

  Gait assessment

  Every year for 3 years

• Changes in Gait assessed by Extended-Time Up and Go (eTUG)

  Gait assessment

  Every year 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 year 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 year for 3 years

• Changes in cognitive function assessed by Frontal Assessment Battery (FAB)

  Cognitive Assessment

  Every year for 3 years

Secondary Outcomes (9)

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale, part III

  Every year for 3 years

• "Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire

  Every year for 3 years

• Hyposmia Rating Scale

  Every year for 3 years

• short Falls Efficacy Scale

  Every year for 3 years

• Berg Balance Scale

  Every year for 3 years

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's Disease

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (3)

ASST- Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Ospedale San Gerardo di Monza

Monza, 20900, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Dario Alimonti, MD, PhD

  ASST- Papa Giovanni XXIII

  PRINCIPAL INVESTIGATOR

• Francesco Biroli, MD

  Fondazione per la Ricerca Ospedale di Bergamo (FROM)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: March 6, 2020
• Study Start: November 9, 2019
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (3)