NCT04297800Completed
Gait Characteristics and Cognitive Evolution in Parkinson Disease
Gait Characteristics and Cognitive Evolution in Parkinson Disease (GECO-PARKINSON STUDY)
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 60 (actual)
- First submitted
- 20 Jan 2020
- Start date
- 9 Nov 2019
- Primary completion date
- 30 Nov 2023
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Diseases
- Parkinson disease
- NCT number
- NCT04297800
What you commit to
- Study type: Observational
- Participants enrolled: 60
- From 9 Nov 2019 to the primary completion date, 30 Nov 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug and alcohol use
Other illness
- 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
Other
- Evidence of neurodegenerative and secondary parkinsonism
Who the study is looking for
- 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)
Age in the registry: 55 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Ospedale San Gerardo di Monza Coordinator of this site? Confirm its status | Monza | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.