Clinical trial Recruiting at 2 sites Interventional

Steps to Improve Walking and Reduce Falls in Parkinson's — Tel Aviv & Bologna

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

Run by University of Kiel · NCT07105787 · Data updated 2026-11-12

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.

More Parkinson Disease trials

Quick facts

Study typeInterventional
SexAll
Enrollment42 (estimated)
SponsorUniversity of Kiel
Academic / other
Locations2 sites (Tel Aviv and 1 other locations)
StatusRecruiting
StartedMarch 31, 2025
Main results expectedMarch 31, 2026
Study endsApril 30, 2026
Registry record updatedAugust 6, 2025
Trial IDNCT07105787 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Tel-Aviv Sourasky Medical Center
    Tel Aviv, Israel
    Recruiting
  • IRCCS Istituto delle Scienze Neurologiche di Bologna
    Bologna, Italy
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.