Stepping program to improve walking and balance in Parkinson's disease

StepuP: Steps Against the Burden of Parkinson's Disease

This tests whether speed-dependent treadmill training, with or without mechanical or virtual-reality perturbations, can improve walking, balance, and daily-life mobility in people with mild-to-moderate Parkinson's disease who have gait problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The University of New South Wales (other)
• Locations: 1 site (Randwick, New South Wales)
• Trial ID: NCT07057219 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial is part of the multi-site StepuP project using a harmonised core protocol to allow pooled analyses while permitting site-specific perturbation adaptations. Participants are randomized to speed-dependent treadmill training with or without mechanical or virtual-reality perturbations, with repeated supervised training sessions delivered in the laboratory. Outcomes include gait kinematics, cortical activity (EEG) and muscle activity (EMG) during lab tasks, plus real-world mobility monitoring to measure transfer of effects to daily life. The trial aims to identify neural and biomechanical mechanisms of change and which patients show meaningful transfer of improvements to everyday walking.

Who should consider this trial

Good fit: Ideal candidates are people with Parkinson's disease (MDS criteria) at Hoehn and Yahr stages I–III with at least mild gait impairment (MDS-UPDRS gait subscore ≥1), able to walk at least one floor and able to give informed consent.

Not a fit: Patients with advanced disability (H&Y >III), inability to walk one floor, implanted deep brain stimulation devices, severe depression or cognitive impairment, severe psychiatric comorbidity, or other medical contraindications to unsupervised exercise are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could improve walking stability and reduce falls in daily life and help clinicians personalise rehabilitation for people with Parkinson's disease.

How similar studies have performed: Previous treadmill and perturbation-based balance training studies in Parkinson's have reported improvements in gait and fall-related outcomes, but clear evidence about the underlying neural mechanisms and real-world transfer remains limited.

Eligibility 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

Randwick, New South Wales

• Neuroscience Research Australia — Randwick, New South Wales, Australia (RECRUITING)

Study contacts

• Principal investigator: Yoshiro Okubo, PhD — Neuroscience Research Australia, University of New South Wales
• Study coordinator: Matthew A Brodie, PhD

Conditions: Parkinson Disease, EEG, EMG, perturbation, VR, real-world gait, wearable device, gait