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NCT Number: NCT04297800

Gait Characteristics and Cognitive Evolution in Parkinson Disease

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

55 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST- Papa Giovanni XXIII, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Every year for 3 years

    Gait assessment

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

    Time frame: Every year for 3 years

    Gait assessment

  3. Changes in cognitive function assessed by Mini-Mental State Examination (MMSE)

    Time frame: Every year for 3 years

    Cognitive Assessment. The MMSE score ranges from 0 to 30 points, in which a lower score indicates a higher degree of cognitive impairment.

  4. Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

    Time frame: Every year for 3 years

    Cognitive Assessment. The total score of the MoCA is 30 points, with a score less than 24 is considered cognitive impairment.

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

    Time frame: Every year for 3 years

    Cognitive Assessment

Secondary outcomes

  1. Movement Disorder Society-Unified Parkinson&#39;s Disease Rating Scale, part III

    Time frame: Every year for 3 years

    The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson&#39;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.

  2. &#34;Rapid eye movement Sleep&#34; Behavior Disorder Screening Questionnaire

    Time frame: Every year for 3 years

    The RBDSQ ranges from 0 to 13, where higher scores represent a worse outcome.

  3. Hyposmia Rating Scale

    Time frame: Every year for 3 years

    The scale ranges from 6 to 24, where higer scores indicate more worse sense of olfaction.

  4. short Falls Efficacy Scale

    Time frame: Every year for 3 years

    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.

  5. Berg Balance Scale

    Time frame: Every year for 3 years

    The BBC includes 14 functional balance. The scale ranges from 0 to 56, where higer scores indicate that the participant can complete the tasks.

  6. Tinetti test

    Time frame: Every year for 3 years

    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

  7. Parkinson's Disease Questionnaire

    Time frame: Every year for 3 years

    PDQ-8 ranges from 0 to 32, where higher scores reflect a lower health-related quality of life.

  8. Beck Anxiety Index

    Time frame: Every year for 3 years

    The BAI range is 0- 63, where higer scores indicate more severe symptoms.

  9. Beck Depression Inventory II

    Time frame: Every year for 3 years

    The BDI-II ranges from 0 to 63, where higer scores indicate more severe depressive symptoms.

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

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

Acronym: GECO-PD

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Mar 6, 2020
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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