Steps Against the Burden of Parkinson's Disease
ConditionParkinson Disease (PD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of New South Wales
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionSDTT adjusts the treadmill's speed in real time to match an individual's walking pace, creating a dynamic and adaptive training environment. This approach simulates real-world walking conditions, promoting neuromuscular coordination, balance, and functional mobility. By tailoring speed to the user's natural gait, SDTT supports the development of efficient and more natural walking patterns. It has shown promise across clinical populations, including those with neurological disorders, musculoskeletal conditions, or recovering from injury. Its flexibility allows for progressive challenge as walking ability improves, making SDTT a valuable tool for optimising gait and mobility outcomes.
Exercise
Other interventionThe SDTT+ program combines speed-dependent treadmill training with perturbations and VR-triggered adaptations. Reactive gait responses are elicited through controlled accelerations and decelerations of treadmill belts, simulating real-life balance challenges.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Speed-dependent treadmill training (SDTT)Active comparator 1 intervention
Group B: SDTT+ perturbations + VR triggered adaptationsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gait speed
Comfortable walking speed overground
Time frame
Baseline (week 1), Post-Training (week 14), Follow-up (week 26)Secondary outcomes
1
Fall Events
The number of falls experienced and whether they resulted in injury will be recorded. This includes a 12-month retrospective report at baseline and ongoing reporting throughout the study.
Time frame
Retrospective report at Baseline (week 1); ongoing reporting through Follow-up (week 26).2
EuroQol 5-Dimension (EQ-5D) Questionnaire
This quality-of-life instrument includes a descriptive profile and a visual analogue scale (VAS) to rate current health. The VAS ranges from 0 (the worst health imaginable) to 100 (the best health imaginable). Higher scores on the VAS indicate better health status.
Time frame
Baseline (week 1), Post-Training (week 14), Follow-up (week 26).3
Frailty Index (FI)
The Frailty Index assesses physical frailty based on five criteria: shrinking (unintentional weight loss), low physical endurance or energy (self-reported exhaustion), low physical activity, weakness (grip strength), and slow walking speed. Based on the number of criteria met (0 to 5), participants are classified into the following categories: Non-frail (0 criteria met) Pre-frail (1-2 criteria met) Frail (3 or more criteria met)
Time frame
Baseline (week 1), Post-Training (week 14), Follow-up (week 26).4
FACIT Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue)
The FACIT Fatigue Scale measures self-reported fatigue and its impact on daily activities and functioning over the past week. Each item is scored on a 5-point Likert scale ranging from 0 ("Not at all") to 4 ("Very much"). Total Score Range: 0 to 52. Higher scores indicate less fatigue and better functioning.
Time frame
Baseline (week 1), Post-Training (week 14), Follow-up (week 26).Other outcomes
1
Fracture History
The number and type of fractures sustained in the 12 months prior to baseline will be recorded.
Time frame
Baseline (week 1).2
Changes in medication
All current medications (including antiparkinsonian and non-antiparkinsonian drugs) will be recorded at each study visit to monitor changes in use and assess potential side effects. Changes in medication will be categorised (e.g., dosage adjustments), and the number of participants with any change in medication will be reported.
Time frame
Baseline (week 1), Post-Training (week 14), Follow-up (week 26).3
Number of participants using mobility aids (indoors and outdoors)
The use of mobility aids (e.g., cane, walker, rollator) will be documented separately for indoor and outdoor environments. The number and percentage of participants using walking aids will be reported at each time point.
Time frame
Baseline (week 1), Follow-up (week 26).4
Hand Grip Strength
Grip strength will be assessed using a hand dynamometer as a proxy for overall strength and frailty.
Time frame
Baseline (week 1).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of New South Wales
Lead sponsor
Neuroscience Research Australia
Collaborator
VU University of Amsterdam
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Shake it up Australia Foundation
Collaborator
Tel Aviv Medical Center
Collaborator
Source ClinicalTrials.gov