Steps to reduce falls and improve walking in Parkinson's disease — Kiel site
Steps Against the Burden of Parkinson's Disease
This trial will try speed-dependent treadmill training, with and without sudden forward/backward perturbations and virtual-reality cues, to see if people with Parkinson's disease walk more steadily and have fewer falls in daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Sex | All |
| Sponsor | University of Kiel Academic / other |
| Locations | 1 site (Kiel) |
| Trial ID | NCT07058285 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial in Kiel compares speed-dependent treadmill training (SDTT) alone versus SDTT plus mechanically triggered anteroposterior perturbations and virtual-reality gait adaptations in people with Parkinson's disease. Participants will undergo supervised treadmill sessions while researchers record brain and muscle activity (EEG, EMG) and detailed movement kinematics. The study will measure changes in lab-based gait, neural activity, and the transfer of any improvements to daily-life mobility using wearable sensors. Results from this site will be pooled with two parallel RCTs in the StepuP project for combined mechanistic and clinical analyses.
Who should consider this trial
Good fit: Ideal participants are people with Parkinson's disease (Hoehn and Yahr stage I–III) who have a gait problem (MDS‑UPDRS gait subscore ≥1), can walk at least one flight of stairs, can give informed consent, and do not have deep brain stimulation or medical conditions that prevent exercise.
Not a fit: Patients with advanced Parkinson's (Hoehn and Yahr >III), implanted deep brain stimulation devices, significant cognitive impairment, uncontrolled psychiatric illness, or other medical conditions that prevent safe exercise are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could help people with Parkinson's walk more stably, build confidence, and reduce falls and related injuries.
How similar studies have performed: Prior trials have shown that treadmill training, particularly when combined with perturbations or virtual-reality cues, can improve gait and reduce falls in Parkinson's disease, but the neural mechanisms and real-world transfer remain incompletely understood.
Eligibility criteria
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 this trial is running
Kiel
- University of Kiel — Kiel, Germany (Recruiting)
Study contacts
- Study coordinator: Walter Maetzler
- Email: w.maetzler@neurologie.uni-kiel.de
- Phone: 0049 431 500-23981
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.