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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: a.m.brodie@unsw.edu.au
• Phone: +614 4988 6272

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.