NCT03477578

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

March 19, 2018

Last Update Submit

July 9, 2019

Conditions

Gait Disorder, SensorimotorCognition DisordersParkinson Disease

Outcome Measures

Primary Outcomes (6)

  • UPDRS

    Unified Parkinson's DIsease Rating Scale

    5 years

  • MMSE

    Mini-Mental State Examination

    5 years

  • FAB

    Frontal Behavioural Assessment

    5 years

  • WCST

    Wisconsin Card Sorting Test

    5 years

  • TMT A-B

    Trial Making Test A and B

    5 years

  • Rey Auditory-Verbal Learning Test

    RAVLT

    5 years

Secondary Outcomes (2)

  • 6MWT

    5 years

  • TUG

    5 years

Study Arms (2)

FoG+

Parkinsonian patients with Freezing of Gait

Other: freezersOther: non freezers

FoG-

Parkinsonian patients withou Freezing of Gait

Other: freezersOther: non freezers

Interventions

freezersOTHER

neuropsychological evaluation

FoG+FoG-
non freezersOTHER

neuropsychological evaluation

FoG+FoG-

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Any other neurological conditions other than PD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Moriggia-Pelascini" Hospital

Gravedona Ed Uniti, CO, 22015, Italy

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicCognition DisordersParkinson Disease

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Giuseppe Frazzitta, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 26, 2018

Study Start

December 1, 2017

Primary Completion

February 28, 2018

Study Completion

March 1, 2018

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)