Gait Disorder, SensorimotorFOG-As-PDNCT03477578
Freezing of Gait and Cognition
An observational study of Gait Disorder, Sensorimotor and Cognition Disorders, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
The study was aimed to investigate the role of cognition n in FoG. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gait Disorder, Sensorimotor, Cognition Disorders, Parkinson Disease
- What is being tested?
- freezers and non freezers
- How many people
- 305 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 1 Mar 2018
- How long will I take part?
- 5 Years
- 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 Any age
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease according to Gelb et al.
Who cannot join
- Any other neurological conditions other than PD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Freezing of Gait and Cognition: What Can we Learn From Cognition?
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.
- Being tested
- freezers, non freezers
- Medical subject headings
- Gait Disorders, Neurologic, Cognition Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
freezersOther
neuropsychological evaluation
non freezersOther
neuropsychological evaluation
| Study group | Role | What they receive |
|---|---|---|
| FoG+ | Parkinsonian patients with Freezing of Gait Receives: Other: freezers; Other: non freezers | |
| FoG- | Parkinsonian patients withou Freezing of Gait Receives: Other: freezers; Other: non freezers |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS
Unified Parkinson's DIsease Rating Scale
Measured: 5 years
MMSE
Mini-Mental State Examination
Measured: 5 years
FAB
Frontal Behavioural Assessment
Measured: 5 years
WCST
Wisconsin Card Sorting Test
Measured: 5 years
TMT A-B
Trial Making Test A and B
Measured: 5 years
Rey Auditory-Verbal Learning Test
RAVLT
Measured: 5 years
Secondary outcomes (2)
6MWT
Six-Minute Walk Test
Measured: 5 years
TUG
Timed Up and Go Test
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Dec 2017
- Primary completion28 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorder, SensorimotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Other
- Enrolment
- 305 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477578
- Sponsor's protocol ID
- FOG-As-PD
- Acronym
- FOG-As-PD
- Status last verified
- Jul 2019
- First submitted
- 19 Mar 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freezing of Gait and Cognition: What Can we Learn From Cognition?
- ClinicalTrials.gov ID
- NCT03477578
- Acronym / sponsor ID
- FOG-As-PD / FOG-As-PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was aimed to investigate the role of cognition n in FoG.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FoG+ | – | Other: freezers, Other: non freezersParkinsonian patients with Freezing of Gait |
| FoG- | – | Other: freezers, Other: non freezersParkinsonian patients withou Freezing of Gait |
Who may qualify
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of idiopathic Parkinson's disease according to Gelb et al.
Key exclusion criteria (1 listed)
- Any other neurological conditions other than PD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| freezersneuropsychological evaluation | Other | FoG+, FoG- |
| non freezersneuropsychological evaluation | Other | FoG+, FoG- |
Primary outcome
UPDRS
Time frame: 5 years
Unified Parkinson's DIsease Rating Scale
MMSE
Time frame: 5 years
Mini-Mental State Examination
FAB
Time frame: 5 years
Frontal Behavioural Assessment
WCST
Time frame: 5 years
Wisconsin Card Sorting Test
TMT A-B
Time frame: 5 years
Trial Making Test A and B
Rey Auditory-Verbal Learning Test
Time frame: 5 years
RAVLT
2 secondary outcomes
6MWT
Time frame: 5 years
TUG
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait Disorder, Sensorimotor and Cognition Disorders, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site 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 1 inclusion and 1 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
UPDRS (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2019.