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
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData 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