Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406374
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
Italian Translation and Validation of the Non-Motor Fluctuation Assessment NoMoFA Questionnaire an Observational Multicentric Cross-sectional 6-months Duration Study on 200 Consecutive Parkinsons Disease Patients
Sponsor:
AOU Città della Salute e della Scienza
Organization:
AOU Città della Salute e della Scienza
Study Overview
Official Title:
Italian Translation and Validation of the Non-Motor Fluctuation Assessment NoMoFA Questionnaire
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NoMoFA
Brief Summary:
Parkinsons 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 patientamp39s 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
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 HampampY and Movement Disorders Unified Parkinsonamp39s 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 evaluatorsamp39 and subjectsamp39 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
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 HampampY and Movement Disorders Unified Parkinsonamp39s 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 evaluatorsamp39 and subjectsamp39 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None