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Parkinson's DiseaseGECO-PDNCT04297800

Gait Characteristics and Cognitive Evolution in Parkinson Disease

An observational study of Parkinson's Disease, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 to 74 years
Conditions the study is for
Parkinson's Disease
How many people
60 participants
Where
3 sitesItaly
Study dates
9 Nov 2019to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Parkinson's Disease

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • ASST- Papa Giovanni XXIII

    Bergamo, 24127

  • Spedali Civili di Brescia

    Brescia, 25123

  • Ospedale San Gerardo di Monza

    Monza, 20900

Other trials in Italy

About this study

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

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.

Read the 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.

Keywords
gait, attention/executive function domain, device, walk parameters, wireless inertial sensor
Medical subject headings
Parkinson Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Gait assessment

    Measured: Every year for 3 years

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

    Gait assessment

    Measured: Every year for 3 years

  3. 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.

    Measured: Every year for 3 years

  4. 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.

    Measured: Every year for 3 years

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

    Cognitive Assessment

    Measured: Every year for 3 years

Secondary outcomes (9)

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

    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.

    Measured: Every year for 3 years

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

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

    Measured: Every year for 3 years

  3. Hyposmia Rating Scale

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

    Measured: Every year for 3 years

  4. 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.

    Measured: Every year for 3 years

  5. 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.

    Measured: Every year for 3 years

  6. 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

    Measured: Every year for 3 years

  7. Parkinson's Disease Questionnaire

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

    Measured: Every year for 3 years

  8. Beck Anxiety Index

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

    Measured: Every year for 3 years

  9. Beck Depression Inventory II

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

    Measured: Every year for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2020
  2. Study start9 Nov 2019
  3. Primary completion30 Nov 2023
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297800
Sponsor's protocol ID
GECO-PARKINSON STUDY
Acronym
GECO-PD
Status last verified
Jan 2025
First submitted
20 Jan 2020
Last updated
8 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Gait assessed by 6-Minute Walk Test (6MWT) (time frame: Every year for 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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