Actively Recruiting
Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
Led by University of Kiel · Updated on 2025-08-06
42
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Kiel
Lead Sponsor
I
IRCCS Istituto delle Scienze Neurologiche di Bologna
Collaborating Sponsor
AI-Summary
What this Trial Is About
Parkinson's disease (PD) affects millions worldwide and often causes unstable walking and falls despite medication. This research aims to understand how treadmill training, with or without added mechanical and virtual reality triggers, can improve walking and prevent falls in people with PD. The study focuses on discovering the brain and movement changes that help improve walking and how these improvements carry over to daily life. The trial is part of a larger project with similar studies combined for a detailed analysis. Participants will take part in 12 sessions of treadmill training. One group will experience speed-dependent treadmill training (SDTT) combined with virtual reality-triggered walking challenges, while the control group will receive regular SDTT. After training, participants can use a phone app for home-based walking practice designed to improve walking adaptability and encourage better movement patterns at their own pace. Throughout the study, participants will have walking and balance tests before and after training, and again at 8 to 12 weeks follow-up. Researchers will collect movement data, brain activity (EEG), and muscle signals (EMG) to study changes. Daily-life walking will be monitored using wearable devices and questionnaires to understand how training effects translate outside the lab. The goal is to identify who benefits most from treadmill training and personalize treatments to improve walking and reduce falls in PD.
CONDITIONS
Brief Title
Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease according to the MDS Criteria
- Hoehn and Yahr stages I to III
- MDS-UPDRS gait sub-score of 1 or more
- Signed informed consent to participate
You will not qualify if you...
- Any general health condition that may interfere with or prevent unsupervised physical exercise
- Moderate or severe depression (BDI-II score 18 or higher)
- Cognitive impairment preventing informed consent
- Less than 75% understanding in ordinary conversation
- Severe psychiatric illness affecting study compliance
- History or current substance dependency
- Unable to walk one floor
- Thoracic pain in the last 4 weeks
- Currently in other interventional studies
- Implanted Deep Brain Stimulation device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 12 weeks
Participants undergo 12 sessions of speed-dependent treadmill training (SDTT), with the experimental group receiving additional virtual reality triggered gait adaptations. Home-based walking training supported by a phone application occurs between sessions.
Approximately 12 training sessions plus home-based walking training
Duration - 12 ± 2 weeks following the intervention (20 to 32 weeks total from baseline)
Participants are monitored for continued effects of the treadmill training on gait and mobility through various clinical, kinematic, and neurophysiological assessments.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 2 locations
1
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
2
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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