Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease
NCT ID: NCT07316751
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
190 participants
OBSERVATIONAL
2025-10-08
2028-11-30
Brief Summary
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Detailed Description
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* Phase I The translation and back-translation process will be conducted by two independent teams; one team will translate the content from English to Italian, followed by another team independently back-translating it from Italian to English (back-translation).
* Phase II Phase II will involve about 10 PD patients, as heterogeneous as possible, from different Italian regions, and 10 clinicians (PD nurses, neurologists, etc) examiners. The instrument, in this preliminary version, will be presented to a group of about 10 PD patients for the pre-test phase. This phase will be used to establish the basic psychometric properties of the scale and identify items that could potentially be culturally complex.
* Phase III Once the official translation has been approved, the instrument will be administered to a sample of PD patients, native Italian speakers, heterogeneous as far as possible in age and gender.
The final Italian version will be assessed for data quality, acceptability, construct validity, and reliability in a cohort of patients diagnosed with Parkinson's disease across multiple Italian centers.
Conditions
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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of PD according to the Movement Disorder Society (MDS) diagnostic criteria (Postuma RB et al., 2015);
* Italian-native patients or patients that understand Italian correctly at least;
* Participants mentally and physically able to understand and sign the informed consent form.
Exclusion Criteria
* Persons with clinically relevant cognitive impairment;
* Persons diagnosed with Parkinsonism other than PD.
18 Years
ALL
No
Sponsors
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
Responsible Party
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Principal Investigators
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Roberto Eleopra, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Neurologico Carlo Besta
Locations
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Ospedale Universitario Luigi Sacco, Milano, Italia
Milan, , Italy
Unità Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze(DNS), Università di Padova, Padova, Italia
Padua, , Italy
Centro per le Malattie Neurodegenerative e l'Invecchiamento Cerebrale, Università degli Studi di Bari "Aldo Moro" presso la Pia Fondazione "Card. G. Panico", Tricase, Italia
Tricase, , Italy
Unità di Neurologia, Divisione Malattia di Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze, Biomedicina e Scienze del Movimento, Università di Verona, Italia
Verona, , Italy
Countries
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Facility Contacts
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References
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Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.
Leta V, Klingelhoefer L, Longardner K, Campagnolo M, Levent HC, Aureli F, Metta V, Bhidayasiri R, Chung-Faye G, Falup-Pecurariu C, Stocchi F, Jenner P, Warnecke T, Ray Chaudhuri K; International Parkinson and Movement Disorders Society Non-Motor Parkinson's Disease Study Group. Gastrointestinal barriers to levodopa transport and absorption in Parkinson's disease. Eur J Neurol. 2023 May;30(5):1465-1480. doi: 10.1111/ene.15734. Epub 2023 Mar 7.
Metta V, Leta V, Mrudula KR, Prashanth LK, Goyal V, Borgohain R, Chung-Faye G, Chaudhuri KR. Gastrointestinal dysfunction in Parkinson's disease: molecular pathology and implications of gut microbiome, probiotics, and fecal microbiota transplantation. J Neurol. 2022 Mar;269(3):1154-1163. doi: 10.1007/s00415-021-10567-w. Epub 2021 Apr 21.
Maxwell SE, Kelley K, Rausch JR. Sample size planning for statistical power and accuracy in parameter estimation. Annu Rev Psychol. 2008;59:537-63. doi: 10.1146/annurev.psych.59.103006.093735.
Camacho M, Greenland JC, Williams-Gray CH. The Gastrointestinal Dysfunction Scale for Parkinson's Disease. Mov Disord. 2021 Oct;36(10):2358-2366. doi: 10.1002/mds.28675. Epub 2021 Jun 16.
Bhidayasiri R, Phuenpathom W, Tan AH, Leta V, Phumphid S, Chaudhuri KR, Pal PK. Management of dysphagia and gastroparesis in Parkinson's disease in real-world clinical practice - Balancing pharmacological and non-pharmacological approaches. Front Aging Neurosci. 2022 Aug 11;14:979826. doi: 10.3389/fnagi.2022.979826. eCollection 2022.
Other Identifiers
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GIDS-PD_ITA
Identifier Type: -
Identifier Source: org_study_id
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