NCT07105787 Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
| NCT ID | NCT07105787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kiel |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-03-31 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis. In this trials, PD patients will undergo treadmill training with and without adaptaions (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a follow-up with pre/post assessments and a follow-up at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns.. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence. Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07105787 clinical trial?
This trial is open to participants of all sexes, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07105787 currently recruiting?
Yes, NCT07105787 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Kiel to inquire about joining.
Where is the NCT07105787 trial being conducted?
This trial is being conducted at Tel Aviv, Israel, Bologna, Italy.
Who is sponsoring the NCT07105787 clinical trial?
NCT07105787 is sponsored by University of Kiel. The trial plans to enroll 42 participants.
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