--- title: Detect subtle walking changes early nct_id: NCT06907589 phase: NA status: RECRUITING sponsor: "Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna" study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT06907589" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06907589" last_fetched: "2026-05-10T14:07:12.945Z" source: "Parkinson's Pathways (curated)" --- # Detect subtle walking changes early **Goal (in five words):** Detect subtle walking changes early **Official Title:** A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care **Trial ID:** [NCT06907589](https://clinicaltrials.gov/study/NCT06907589) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna - **Target Enrollment:** 250 participants - **Start Date:** 2024-05-13 - **Completion Date:** 2026-01 - **Conditions:** Parkinson Disease, Healthy Adult - **Interventions:** Motor Data Analysis - **Intervention Types:** DEVICE ## Summary For Families Aims to make Parkinson's easier to catch early and to follow over time by providing an accessible, tech-based way to measure motor signs and keep care continuous. It uses technology to record and analyze motor tasks like walking and other movements, turning those recordings into objective movement metrics that can flag subtle Parkinson's signs and show how symptoms change with medication. The trial seeks adults 50 to 80 years old, either healthy volunteers or people with Parkinson's at Hoehn and Yahr stages 1,3 who can walk without a cane and have an MMSE of 24 or higher. Parkinson's participants are examined while ON their usual medication and should not have dyskinesias or need walking aids. ## Eligibility - **Minimum age:** 50 Years - **Maximum age:** 80 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: 1. Healthy subjects - Inclusion Criteria: * Adult subjects, both sexes, aged 50-80 years old * MMSE score \>= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score \<=5; age class 60-69 years: normal with score \<=6; age class \> 70 years: normal with score \<=7 * absence of neurological diseases * absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine * expression of informed consent to participate in the study 2. Subjects with Parkinson's disease -- Inclusion criteria: * adult subjects, both sexes, 50-80 years of age * MMSE score \>= 24 * subjects with Parkinson's disease in the absence of motor fluctuations and dyskinesias, or subjects with Parkinson's disease with mild motor fluctuations throughout the day, but to be examined in the ON phase and in the absence of dyskinesias * Hoehn and Yahr stage 1, 2, 3 * absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine * expression of informed consent to participate in the study Exclusion Criteria: 1. Healthy subjects - Exclusion criteria: * denial of informed consent to participate in the study * Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score \>=6; age class 60-69 years: hyposmia with score \>=7; age class \> 70 years: hyposmia with score \>=8 * body weight greater than 120 kg * insufficient degree of cooperation * malignant neoplasm in progress or with negative follow-up of less than 6 years * structured joint stiffness in the upper and/or lower extremities preventing proper execution of movements * paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury * mono/multi/poly sensory and/or motor neuropathy * chronic inflammatory diseases with joint involvement of the upper and/or lower limbs * vertiginous syndromes in the acute phase * neurodegenerative diseases * fever * venous thrombosis * cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises * spinal or joint pain of various etiologies that may affect the performance of motor exercises * positive history of recurrent acute cervico-brachialgia and/or lumbosciatica 2. Subjects with Parkinson's disease - Exclusion criteria: * Denial of informed consent to participate in the study * Hoenn and Yahr stage 4, 5 * Patient who needs to use an aid (cane or walker) while walking or cannot walk unless aided by a person * body weight greater than 120 kg * insufficient degree of cooperation * malignant neoplasm in place or with negative follow-up of less than 6 years * structured joint stiffness in the upper and/or lower extremities that prevents proper execution of movements * paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury mono/multi/poly sensory and/or motor neuropathy * chronic inflammatory diseases with joint involvement of the upper and/or lower limbs * vertiginous syndromes in the acute phase * neurodegenerative diseases, excluding Parkinson's disease * fever * venous thrombosis * cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises * spinal or joint pain of various etiologies that may affect the performance of motor exercises * positive history of recurrent acute cervico-brachialgia and/or low back pain ``` ## Locations (5) - Ospedale Santa Maria Annunziata AUSL Toscana Centro, Bagno a Ripoli, Firenze, Italy _(43.7512, 11.3225)_ - Paola Vanni — (CONTACT) — +390552313862 — paola.vanni@uslcentro.toscana.it - Azienda Ospedaliero Universitaria Careggi, Florence, Italy _(43.7792, 11.2463)_ - Silvia Ramat — (CONTACT) — +390557947956 — silvia.ramat@unifi.it - IRCCS Fondazione Don Carlo Gnocchi Firenze, Florence, Italy _(43.7792, 11.2463)_ - Gemma Lombardi — (CONTACT) — +3905557393917 — glombardi@dongnocchi.it - Ospedale Apuane AUSL Toscana Nord Ovest, Massa, Italy _(44.0354, 10.1393)_ - Carlo Maremmani — (CONTACT) — +3905854931 — carlo.maremmani@uslnordovest.toscana.it - IRCCS Istituto Auxologico Italiano, Ospedale San Luca, Milan, Italy _(42.7824, 12.5984)_ - Andrea Ciammola — (CONTACT) — +39026191129 — a.ciammola@auxologico.it ## Central Contacts - Filippo Cavallo — (CONTACT) — +390552758663 — filippo.cavallo@santannapisa.it - Erika Rovini — (CONTACT) — +390553758663 — erika.rovini@unifi.it --- *Canonical: https://parkinsonspathways.com/trial/NCT06907589* *HTML version: https://parkinsonspathways.com/trial/NCT06907589* *Source data: https://clinicaltrials.gov/study/NCT06907589*