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. - Trial NCT06406374

Timeline & Enrollment

Primary Outcome

Non-motor fluctuations assessment

Summary

Parkinson's disease (PD) has been traditionally considered a movement disorder. In fact, it
 is now recognized as a multisystemic disease involving not only the central nervous system
 and presenting with a constellation of motor and non-motor features. While the dopaminergic
 therapy used to control motor symptoms can lead to the development of motor fluctuations,
 characterized by wearing-off, ON-OFF phenomenon, delayed-ON, dose failure, and dyskinesias,
 it has been demonstrated that also many non-motor symptoms can have daily fluctuations,
 according to the response to dopaminergic therapy. Therefore, non-motor symptoms may
 fluctuate in parallel with motor symptoms and their relationship to plasma dopamine
 concentration, although the exact mechanism of non-motor fluctuations (NMF) remains
 speculative. Non-motor features tend to worsen during disease progression and prove to
 severely impact the quality of life of patients, sometimes more than motor symptoms. The
 Non-Motor Fluctuation Assessment (NoMoFA) Questionnaire is a patient-derived and
 self-administered questionnaire, recently developed and validated by the International
 Parkinson and Movement Disorder Society (MDS), that identifies and quantifies the severity of
 static and fluctuating non-motor symptoms in people with PD. The NoMoFA scale is constituted
 of a total of 27 items investigating several non-motor features, such as fatigue (the most
 reported), sleepiness, and confusion. Considering the self-administered nature of the scale,
 patients must understand the questions, and it should be available in the patient#39;s
 native language. However, the NoMoFa has not yet been translated into the Italian language.
 Considering that NoMoFA is a relevant scale in the assessment of patients with PD, we believe
 it is important to perform a translation and cross-cultural adaptation of the NoMoFA
 questionnaire in Italian, following the scales translation protocol from the international
 movement disorders society (MDS), and to analyze the reliability and construct validity of
 the translated scale in Italian patients with PD who experience non-motor fluctuations. The
 aim of the study is to translate and validate the adapted Italian version of NoMoFA
 questionnaire.

ICD-10 Classifications