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Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna

RecruitingNAAges any - anyAllUniversity of Kiel
NCT07105787 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life. This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that dat

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📋 Eligibility rules (as published)
Inclusion criteria 1. Diagnosis of PD according to the MDS Criteria 2. Hoehn and Yahr stages I to III; 3. Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more 4. Signed informed consent to participation Exclusion criteria * Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise. * Moderate or severe depression (BDI-II ≥18) * Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment. * Linguistic comprehension capacity less than 75% in ordinary conversation * Severe psychiatric comorbidity which may interfere with compliance to the study protocol History of or current status of substance dependency * Unable to walk less than 1 floor * Thoracic pain in the last 4 weeks * Currently enrolled in other interventional studies * Implanted Deep Brain Stimulation device
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What it tests

  • SDTT + VR triggered adaptations
  • Speed-dependent treadmill training (SDTT)
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Where

2 sites
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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