Italian Translation and Validation of the GIDS-PD Scale for Parkinson's Disease

NCT07316751 | Recruiting

• 1 other identifier: GIDS-PD_ITA
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 5

Brief Summary

This study aims to translate and validate the Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) into Italian to enable the assessment of gastrointestinal symptoms in Italian-speaking patients with Parkinson's disease. The psychometric properties of the translated instrument will be evaluated through a multi-phase process involving translation/back-translation, pre-testing, and large-scale validation across multiple Italian centers

Conditions

PARKINSON DISEASE (Disorder); Parkinson Disease

Keywords

Parkinson's Disease; Gastrointestinal Dysfunction; Scale Validation

Outcome Measures

Primary Outcomes (1)

• Translation the Italian version of GIDS-PD

  Score on the Italian version of the Geriatric Impulse Dyscontrol Scale-Parkinson's Disease (GIDS-PD), total score ranging from 0 to 100, with higher scores indicating greater impulse control difficulties.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients with PD attending the movement disorders Units of the study centres.

You may qualify if:

• 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.

You may not qualify if:

• Persons in the terminal phase of disease;
• Persons with clinically relevant cognitive impairment;
• Persons diagnosed with Parkinsonism other than PD.

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (5)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, 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

Padua, 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

Related Publications (7)

• 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.

  PMID: 17161752 BACKGROUND

• 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.

  PMID: 26474316 BACKGROUND

• 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.

  PMID: 36757008 BACKGROUND

• 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.

  PMID: 33881598 BACKGROUND

• 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.

  PMID: 17937603 BACKGROUND

• 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.

  PMID: 34133059 BACKGROUND

• 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.

  PMID: 36034128 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roberto Eleopra, MD

  Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 5, 2026
• Study Start: October 8, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)