Italian version of the GIDS-PD (Gastrointestinal Dysfunction Scale for Parkinson's disease)
Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease
This project will test an Italian translation of the Gastrointestinal Dysfunction Scale for people with Parkinson's disease to help measure stomach and bowel symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 5 sites (Milan and 4 other locations) |
| Trial ID | NCT07316751 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with Parkinson's disease per MDS diagnostic criteria who are native Italian speakers or understand Italian well and can give informed consent are ideal candidates.
Not a fit: Patients in the terminal phase, those with clinically relevant cognitive impairment, individuals with Parkinsonism other than Parkinson's disease, and non-Italian speakers are unlikely to benefit from this validation effort.
Why it matters
Potential benefit: If successful, clinicians and patients in Italy will have a reliable Italian questionnaire to track gastrointestinal symptoms in Parkinson's disease, improving recognition and management of these non-motor symptoms.
How similar studies have performed: The original GIDS-PD has been used in English and similar translation/validation efforts for Parkinson's symptom scales have generally produced reliable localized instruments using this methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.