Italian version of the GIDS-PD (Gastrointestinal Dysfunction Scale for Parkinson's disease)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project follows MDS guidelines with a three-phase approach: independent translation and back-translation, a small pre-test, and a large-scale validation across multiple Italian centers. Phase I uses two independent teams to translate and back-translate the GIDS-PD. Phase II will pre-test the draft instrument with about 10 diverse PD patients and 10 clinician examiners to spot culturally sensitive items and check basic psychometric properties. Phase III will administer the approved Italian version to a larger, heterogeneous cohort of native Italian PD patients to evaluate data quality, construct validity, and reliability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years;
* 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 in the terminal phase of disease;
* Persons with clinically relevant cognitive impairment;
* Persons diagnosed with Parkinsonism other than PD.

Where it's running

• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Italy Recruiting
• Ospedale Universitario Luigi Sacco, Milano, Italia
  Milan, Italy Not yet recruiting
• Unità Parkinson e Disturbi del Movimento, Dipartimento di Neuroscienze(DNS), Università di Padova, Padova, Italia
  Padova, Italy Not yet recruiting
• 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 Not yet recruiting
• 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 Not yet recruiting

Study contacts

• Principal investigator: Roberto Eleopra, MD — Fondazione IRCCS Istituto Neurologico Carlo Besta

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.