- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06406374
Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire: an Observational, Multicentric, Cross-sectional, 6-months Duration Study on 200 Consecutive Parkinson's Disease Patients. (NoMoFA)
Italian Translation and Validation of the Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire.
Study Overview
Status
Conditions
Detailed Description
This is a multicenter, cross-sectional study involving 200 consecutive patients with a diagnosis of idiopathic PD.
We will collect demographic data such as age, sex and education, and clinical features encompassing age at onset, disease duration, antiparkinsonian treatment, and levodopa-equivalent daily dose (LEDD). Patients will undergo a clinical examination in which we will record the Hoehn and Yahr scale (H&Y) and Movement Disorders Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I-II- III (in ON state) and IV, and Montreal Cognitive Assessment (MoCA). The answers to the NoMoFA will be obtained giving the self-administered questionnaire to patients during regular follow-up visits. The NoMoFA Questionnaire has a total of 27 items with a total maximum possible score for the NoMoFA of 81 points (27 x 3). To evaluate the stability of the Italian version of the NoMoFA (test-retest reliability), a group of 60 patients will repeat the scale 14 days after the first evaluation.
We will establish a translation team composed of movement disorders specialists who are native speakers of the designated language and fluent in English. As word-for-word translations can be misleading, cultural difference between English and Italian will be taken into account. After translation, a different independent group with same competencies of the first translating team will perform a back-translation. The back-translated version of the rating scale will be compared to the original English version. The translation and back-translation team members in a revised document will fully resolve unclear concepts or ambiguities between the original and back-translated English editions. Before the validation phase, a so-called 'cognitive pretesting' will be performed by submitting the provisional translated scale to 10 PD patients by 2 evaluators external to the translator team. Then, evaluators' and subjects' responses will be integrated into the revisions and retested until all major problems are resolved. Once the translation and cognitive pretesting stages are completed, the translated scale is field-tested in a sample of native speakers of the language of the translated scale (validation).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carlo Alberto Artusi, MD, PhD
- Phone Number: +390116709366
- Email: carloalberto.artusi@unito.it
Study Locations
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TO
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Torino, TO, Italy, 10126
- Recruiting
- Dipartimento di Neuroscienze e Salute Mentale SC Neurologia 2U
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Contact:
- Carlo Alberto Artusi, MD, PhD
- Phone Number: 011 6709366
- Email: carloalberto.artusi@unito.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease according to the 2015 Movement Disorders Society (MDS) criteria (Postuma et al. Mov Dis, 2015);
- Italian speaker;
- Mini-mental state examinations (MMSE) score >25;
- Presence of symptoms fluctuations, as per a Wearing-off questionnaire 19 (WOQ-19) score>=2;
- Stable antiparkinsonian medications for at least three months
- Ability to provide informed consent.
Exclusion Criteria:
- Atypical Parkinsonian syndrome
- H&Y>4
- Patients under legal protection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Parkinson's disease patients
Patients will present the following inclusion criteria:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-motor fluctuations assessment
Time Frame: The entire project is planned for a duration of 13 months.
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The aim of this study is to validate an Italian version of NoMoFA scale for the evaluation of non-motor symptoms fluctuations.
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The entire project is planned for a duration of 13 months.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0068862
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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