Steps Against the Burden of Parkinson's Disease

Recruiting now · Not applicable

Conditions studied: Parkinson Disease (PD)

In brief

Parkinson's Disease Treadmill Training RCT Summary Parkinson's disease (PD) affects over 10 million people globally. Despite optimal pharmacological treatment, approximately 70% of individuals experience unstable gait and falls, leading to loss of confidence, social isolation, fractures, and frequent hospitalisations. Treadmill training-especially when augmented by mechanical or virtual-reality perturbations-has shown promise in improving gait and reducing fall risk. However, the mechanisms underlying these benefits remain poorly understood, limiting the ability to personalise interventions effectively. This randomised controlled trial (RCT) forms part of the broader Steps Against the Burden of Parkinson's Disease project (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004), comprising three harmonised but independently conducted RCTs. All sites follow a shared core protocol, allowing for pooled data analysis while preserving site-specific perturbation adaptations. Findings from this trial will be reported both independently and as part of the combined dataset. In this trial, participants with PD will undergo 12 sessions of treadmill training, with or without virtual reality and perturbation-based adaptations. Assessments will be conducted at baseline, post-training, and follow-up. The intervention aims to enhance gait through improved sensorimotor integration and balance control. During the follow-up period, a smartphoneapp "Walking Tall" will be used to encourage continued exercises and long-term retention of training effects. Biomechanical analyses will focus on changes in foot placement control. Neurophysiological outcomes will be examined using EEG and EMG, targeting reductions in beta-band EEG power and enhanced EEG-EMG coherence as markers of improved gait stability. Recognising that laboratory-based improvements may not always translate to daily life, this study will also investigate gait self-efficacy as a potential moderator of transfer. Remote monitoring tools will capture real-world mobility outcomes over a week. Machine learning techniques will be employed to identify factors differentiating those who improve in both settings from those who do not. These insights will inform the development of personalised interventions capable of translating training effects into meaningful real-life outcomes.

Key facts

Study ID: NCT07057219
Run by: The University of New South Wales
People needed: 42
Starts: 2025-07-09
Expected to finish: 2026-11-30
Last updated by the study team: 2025-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Diagnosis of PD according to the MDS Criteria
Hoehn and Yahr stages I to III;
Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more
Signed informed consent to participation

You may not qualify if…

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 is running

Neuroscience Research Australia — Randwick, New South Wales, Australia (enrolling)

Full record on ClinicalTrials.gov

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