RecruitingNot ApplicableNCT07105787

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

Sponsor

University of Kiel

Enrollment

42 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Falls

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

Plain Language Summary

Simplified for easier understanding

This study is testing a walking exercise program to help people with Parkinson's disease move better and feel better overall. Researchers in Tel Aviv and Bologna want to see if a structured step-based exercise routine can reduce the burden of Parkinson's symptoms. **You may be eligible if:** - You have been diagnosed with Parkinson's disease - Your disease is in an early to moderate stage (Hoehn and Yahr stages I to III) - You have some difficulty with your walking gait - You are able to give informed consent **You may NOT be eligible if:** - You have a health condition that makes unsupervised exercise unsafe - You have moderate to severe depression - You have significant memory or thinking problems - You struggle to understand ordinary conversation - You have a serious psychiatric condition or substance dependency - You cannot walk up at least one flight of stairs - You have had chest pain in the last 4 weeks - You are already in another clinical trial - You have a deep brain stimulation device implanted Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSDTT + VR triggered adaptations

The SDTT+ VR triggered adaptations program will trigger reactive gait adaptations by presenting obstacles in VR.

OTHERSpeed-dependent treadmill training (SDTT)

This training methodology focuses on adjusting the treadmill's speed according to the individual's walking pace, creating a more dynamic and adaptive exercise environment. SDTT is designed to mimic real-world walking conditions and challenges, promoting neuromuscular coordination, balance, and overall mobility. By tailoring the treadmill speed to match the user's gait, SDTT encourages the development of natural and efficient walking patterns. This training technique has shown promise in various clinical settings, aiding individuals with gait impairments caused by neurological conditions, musculoskeletal disorders, or post-injury rehabilitation. Its adaptability allows for progressive adjustments as a person's walking abilities improve, making it a versatile tool for optimizing gait mechanics and functional mobility. To ensure continued progress and integration into daily life, home-based walking training, supported by a phone application, will be included between T1 and T2.