Steps Against the Burden of Parkinson's Disease

NCT07057219 | Recruiting

• 2 other identifiers: iRECS51142022885
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease (PD)

Keywords

EEG; EMG; perturbation; VR; real-world gait; wearable device; gait; balance; falls

Outcome Measures

Primary Outcomes (1)

• Gait speed

  Comfortable walking speed overground

  Baseline (week 1), Post-Training (week 14), Follow-up (week 26)

Secondary Outcomes (25)

• Fall Events

  Retrospective report at Baseline (week 1); ongoing reporting through Follow-up (week 26).

• EuroQol 5-Dimension (EQ-5D) Questionnaire

  Baseline (week 1), Post-Training (week 14), Follow-up (week 26).

• Frailty Index (FI)

  Baseline (week 1), Post-Training (week 14), Follow-up (week 26).

• FACIT Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue)

  Baseline (week 1), Post-Training (week 14), Follow-up (week 26).

• Visual Analogue Scale (VAS)

  Baseline (week 1), Post-Training (week 14), Follow-up (week 26).

Other Outcomes (4)

• Fracture History

  Baseline (week 1).

• Changes in medication

  Baseline (week 1), Post-Training (week 14), Follow-up (week 26).

• Number of participants using mobility aids (indoors and outdoors)

  Baseline (week 1), Follow-up (week 26).

Study Arms (2)

Speed-dependent treadmill training (SDTT)

ACTIVE COMPARATOR

SDTT 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.

Other: Exercise

SDTT+ perturbations + VR triggered adaptations

EXPERIMENTAL

The 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.

Other: Exercise

Interventions

Exercise OTHER

SDTT 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.

Also known as: SDTT, Treadmill training, Gait training

Speed-dependent treadmill training (SDTT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of New South Wales: lead
• 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

Study Sites (1)

Neuroscience Research Australia

Randwick, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Matthew Brodie, PhD

  University of New South Wales

  STUDY CHAIR

• Yoshiro Okubo, PhD

  Neuroscience Research Australia, University of New South Wales

  PRINCIPAL INVESTIGATOR

• Daniel Chan, PhD, MD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

• Luca Modenese, PhD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

• Frederic von Wegner, PhD, MD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

• Phu Hoang, PhD, MD

  Neuroscience Research Australia

  PRINCIPAL INVESTIGATOR

• Husna Razee, PhD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

• Paulo Silva Pelicioni, PhD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

• Vicki Miller

  Shake it up Australia Foundation

  PRINCIPAL INVESTIGATOR

• Carolyn Sue, PhD, MD

  Neuroscience Research Australia

  PRINCIPAL INVESTIGATOR

• Martin Ostrowski, PhD

  University of New South Wales

  PRINCIPAL INVESTIGATOR

• Mayna Ratanapongleka

  Neuroscience Research Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew A Brodie, PhD

CONTACT

+614 4988 6272; a.m.brodie@unsw.edu.au

Yoshiro Okubo, PhD

CONTACT

+61 293991065; y.okubo@neura.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conjoint Senior Lecturer

Model Details: A randomised controlled trial

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: July 9, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: The pseudonymized personal dataset corresponding to study participants who have opted in at the time of consent will be made available within two years of study completion
• Access Criteria: Researchers comply with applicable data protection law, particularly Chapter V of the GDPR and the recommendations of the European Data Protection Board. Researchers submit an approved data management and intended use plan. Researchers approved by all sites including the University of New South Wales Human Research Ethics Committee.

Locations

AU (1)