SDTT + VR triggered adaptations for Parkinson's (NCT07105787)
Improve walking speed and stability
- Trial ID
- NCT07105787
- Official Title
- Steps Against the Burden of Parkinson's Disease - TelAviv/Bologna
- Goal
- Improve walking speed and stability
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Kiel
- Study Type
- INTERVENTIONAL
- Enrollment
- 42 participants
- Conditions
- Parkinson Disease, Falls
- Interventions
- SDTT + VR triggered adaptations, Speed-dependent treadmill training (SDTT)
Summary For Families
The goal is to reduce falls and make everyday walking steadier by improving gait stability and adaptability in people with Parkinson's who already have trouble walking. The approach uses speed-dependent treadmill training, where the treadmill automatically matches and challenges your walking speed to retrain step timing and balance, combined with virtual-reality triggered changes that force quick adjustments so your brain and muscles learn to respond better; it is a rehabilitation program that complements usual Parkinson's medications rather than replacing them. They are looking for adults diagnosed with Parkinson's by MDS criteria, Hoehn and Yahr stages I to III, with at least a mild gait problem on the MDS‑UPDRS, who can walk one floor and do not have major cognitive impairment, severe depression, an implanted DBS device, or other health issues that make unsupervised exercise unsafe.
Locations
- Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel
- IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying SDTT + VR triggered adaptations. The goal is to reduce falls and make everyday walking steadier by improving gait stability and adaptability in people with Parkinson's who already have trouble walking. The approach uses speed-dependent treadmill training, where the treadmill automatically matches and challenges your walking speed to retrain step timing and balance, combined with virtual-reality triggered changes that force quick adjustments so your brain and muscles learn to respond better; it is a rehabilitation program that complements usual Parkinson's medications rather than replacing them. They are looking for adults diagnosed with Parkinson's by MDS criteria, Hoehn and Yahr stages I to III, with at least a mild gait problem on the MDS‑UPDRS, who can walk one floor and do not have major cognitive impairment, severe depression, an implanted DBS device, or other health issues that make unsupervised exercise unsafe.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- You will attend 12 treadmill training sessions, with pre- and post-training assessments and a follow-up 8 to 12 weeks after the post assessment.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain wave recording (EEG) (non-invasive); Questionnaires & surveys (non-invasive); Wearable / at-home monitoring (non-invasive). Confirm the full schedule with the study coordinator.