Steps to Improve Walking and Reduce Falls in Parkinson's — Tel Aviv & Bologna
Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
This trial will test whether speed-dependent treadmill training with mechanical and VR-triggered gait challenges helps people with mild-to-moderate Parkinson's disease walk more stably and transfer those gains to daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Sex | All |
| Sponsor | University of Kiel Academic / other |
| Locations | 2 sites (Tel Aviv and 1 other locations) |
| Trial ID | NCT07105787 on ClinicalTrials.gov |
What this trial studies
This randomized, site-specific trial applies speed-dependent treadmill training (SDTT) with and without mechanically and VR-triggered gait perturbations to people with Parkinson's disease (Hoehn & Yahr I–III). Participants undergo lab-based kinematic, EMG, and EEG measurements before and after training and are monitored for transfer of improvements to daily-life gait using wearable sensors. The protocol is one of three parallel randomized trials using a shared core design with pooled analysis across sites to examine neural and biomechanical mechanisms and individual response differences. Outcomes include lab gait measures, neural activity changes, gait self-efficacy, and mobility in daily life.
Who should consider this trial
Good fit: Ideal candidates are people with Parkinson's disease (MDS criteria) in Hoehn & Yahr stages I–III who can walk at least one floor, have a gait-related score on the MDS-UPDRS, can give informed consent, and do not have implanted DBS or major contraindications to exercise.
Not a fit: Patients with advanced Parkinson's disease, implanted deep brain stimulators, significant cognitive impairment, uncontrolled psychiatric conditions, severe depression, or any medical contraindication to unsupervised exercise are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the approach could improve walking stability, increase confidence, and reduce falls by tailoring treadmill training to patients' gait and neural profiles.
How similar studies have performed: Previous trials have shown that treadmill training and perturbation-based or VR-augmented approaches can improve gait and reduce falls, but linking those benefits to specific neural mechanisms and predicting individual transfer to daily life is less established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tel Aviv and 1 other locations
- Tel-Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- IRCCS Istituto delle Scienze Neurologiche di Bologna — Bologna, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.