ClinicalTrials.gg
CompletedNCT03477578FOG-As-PDUpdated Jul 11, 2019

Freezing of Gait and Cognition

An observational study in Gait Disorder, Sensorimotor, Cognition Disorders and Parkinson Disease, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2019-07-11.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
305
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Gait Disorders, Neurologic with a site in Italy — 2 open to participants now, 3 under way, none of them phase 3. Gait Disorders, Neurologic · Italy.

Started
2017
with 5 others
Observational
5 of 25
none open now
Registered
7th of 25
by date
Lead sponsor
4 of 25
Ospedale Generale Di Zona Moriggia-Pelascini

Among the 25 studies in Gait Disorders, Neurologic with a site in Italy, this one is one of 6 that started in 2017, is one of 5 observational ones, and was the 7th registered.

Gait Disorders, Neurologic

346 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.

Browse Gait Disorders, Neurologic studies →

Open to participants now

2 of the 25 studies in Gait Disorders, Neurologic with a site in Italy are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →

Who these studies take

Of the 36 Gait Disorders, Neurologic studies recruiting now, 14 (39%) set no upper age limit and 19 (53%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.

The full table on the hub →

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02

Study summary

The study was aimed to investigate the role of cognition n in FoG.

Read the detailed description

Alteration of cortical circuits in PD leads to cognitive dysfunctions associated with the development of FoG.

The study was aimed to investigate the role of cognition in FoG.

03

Conditions studied

  • Gait Disorder, Sensorimotor
  • Cognition Disorders
  • Parkinson Disease
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sampling method
Non-probability sample

Study population

Parkinsonian patients with and without freezing of gait hospitalized at the Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of idiopathic Parkinson's disease according to Gelb et al.

Exclusion criteria

Exclusion Criteria:

  • Any other neurological conditions other than PD
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
305 participants (actual)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • FoG+

    Parkinsonian patients with Freezing of Gait

    Other: freezers · Other: non freezers

  • FoG-

    Parkinsonian patients withou Freezing of Gait

    Other: freezers · Other: non freezers

Interventions

  • Otherfreezers

    neuropsychological evaluation

  • Othernon freezers

    neuropsychological evaluation

06

What researchers measure

Primary outcomes

  1. UPDRS

    Unified Parkinson's DIsease Rating Scale

    Time frame: 5 years

  2. MMSE

    Mini-Mental State Examination

    Time frame: 5 years

  3. FAB

    Frontal Behavioural Assessment

    Time frame: 5 years

  4. WCST

    Wisconsin Card Sorting Test

    Time frame: 5 years

  5. TMT A-B

    Trial Making Test A and B

    Time frame: 5 years

  6. Rey Auditory-Verbal Learning Test

    RAVLT

    Time frame: 5 years

Secondary outcomes

  1. 6MWT

    Six-Minute Walk Test

    Time frame: 5 years

  2. TUG

    Timed Up and Go Test

    Time frame: 5 years

07

Study locations

1 site
  • "Moriggia-Pelascini" Hospital
    Gravedona Ed Uniti, CO 22015, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Feb 2018, 2 months.

Of 45 non-industry observational studies under Gait Disorders, Neurologic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 46. This study's 2 months is below that.

Counting every sponsor, half of 46 studies reached it within 17 months; a quarter within 3 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 19, 2018
First posted
Mar 26, 2018
StartActual
Dec 1, 2017
Primary completionActual
Feb 28, 2018
CompletionActual
Mar 1, 2018
Last update
Jul 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03477578
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Sponsor
First posted
Mar 26, 2018
Start date
Dec 1, 2017
Primary completion
Feb 28, 2018
Completion
Mar 1, 2018
Last update
Jul 11, 2019

Study contacts

Giuseppe Frazzitta, MD
principal investigator · Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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