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Taking people in ItalyNo phase

Treadmill walking training with added triggers for Parkinson's disease

Tests treadmill walking training with and without added triggers in people with Parkinson's disease.

Key facts

Who runs it
University of Kiel
Where
Bologna, ItalySee the siteAlso in 1 other country, 1 site
Trial code
Registry title
Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
Status
Recruiting
People taking part
42 people, planned
Started
31 Mar 2025
Planned end
30 Apr 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • SDTT + VR triggered adaptations
  • Speed-dependent treadmill training (SDTT)
Record updated
6 August 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with Parkinson's disease at an early to middle stage who have some walking problems. They will do treadmill training.

Sex
Men and women can join.
Disease stage
Parkinson's disease diagnosed by the MDS criteria, Hoehn and Yahr stages I to III, with an MDS-UPDRS gait sub-score of 1 or more.

Main reasons for not taking part

  • Any health condition that could interfere with exercise without medical supervision
  • Moderate or severe depression (BDI-II ≥18)
  • Cognitive impairment that prevents informed consent
  • Implanted Deep Brain Stimulation device
  • Currently enrolled in other interventional studies

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Diagnosis of PD according to the MDS Criteria
  • Hoehn and Yahr stages I to III
  • Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more
  • Signed informed consent to participation

Who cannot take part

  • Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise
  • Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment
  • Severe psychiatric comorbidity which may interfere with compliance to the study protocol History of or current status of substance dependency
  • Moderate or severe depression (BDI-II ≥18)
  • Linguistic comprehension capacity less than 75% in ordinary conversation
  • 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 in Italy

Also in 1 other country, 1 site

  • IRCCS Istituto delle Scienze Neurologiche di BolognaBologna, ItalyContact: Fabio LaportaTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • ExperimentalTreatment being tested

    The experimental group will engage in 12-sessions of SDTT with additional virtual reality triggered adaptations, contrasting with the control group undergoing regular SDTT.

    Treatment: SDTT + VR triggered adaptations

  • ControlExisting treatment, for comparison

    Treatment: Speed-dependent treadmill training (SDTT)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
Plain-language title
Treadmill walking training with added triggers for Parkinson's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 August 2025