Steps Against the Burden of Parkinson's Disease

Not Applicable

Recruiting

• Conditions: Parkinson Disease (PD)

• Registration Number: NCT07057219
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

i. Rationale The rationale of this trial is that speed-dependent treadmill training (SDTT) improves gait in people with Parkinson's disease (PD) through enhanced sensorimotor integration, with cortical activity changes as underlying neural correlates. Additional benefits may be gained when treadmill training includes perturbations, which help train reactive balance responses. Furthermore, it is hypothesised that improvements in gait quality through SDTT can enhance gait self-efficacy, which may mediate or moderate the transfer of training effects to everyday mobility. Understanding these mechanisms is essential for personalising interventions and maximising real-world outcomes.

ii. Objectives

The objectives of the StepuP project are to:

1. Understand the kinematic and neural mechanisms that underlie improvements in gait due to treadmill training with and without mechanically and VR-triggered gait adaptations in people with PD.

2. Assess the extent to which gait improvements measured in the laboratory transfer to improvements in daily-life mobility.

3. Identify the mechanisms that support or limit the transfer of training effects from lab-based gait improvements to real-world mobility.

4. Determine for whom treadmill training improves gait characteristics in the lab and for whom it does not, and similarly, who benefits in terms of daily-life mobility.

Achieving these objectives will advance understanding of the variability in individual response to treadmill training, allowing more targeted and ultimately personalised interventions to improve outcomes in PD.

iii. Endpoints This trial will evaluate the effects of treadmill training with and without perturbations on gait performance and neural correlates in people with PD.

Primary endpoint:

\> Change in gait speed under controlled treadmill conditions.

Secondary endpoints:

* Clinical outcomes: Changes in motor symptoms and function measured through clinical assessments.

* Kinematic outcomes: Changes in gait parameters such as step length and variability from baseline to follow-up.

* Neurophysiological outcomes: EEG and EMG markers, including changes in EEG beta power and EEG-EMG coherence.

Exploratory endpoints:

* Real-world gait metrics assessed via wearable sensors.

* Gait self-efficacy assessed with validated questionnaires to examine psychological influences on transfer.

These outcomes will help identify how and for whom treadmill training leads to meaningful, lasting improvements in mobility.

Study Timeline

• Study First Submitted: 2025-05-19
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-06
• Study Start: 2025-07-09
• Study First Posted: 2025-07-09
• Last Update Submitted: 2025-07-13
• Last Update Posted: 2025-07-17
• Primary Completion: 2026-09-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait speed	Baseline (week 1), Post-Training (week 14), Follow-up (week 26)	Comfortable walking speed overground

Secondary Outcome Measures

Name	Time	Method
EuroQol 5-Dimension (EQ-5D) Questionnaire	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	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.
Fall Events	Retrospective report at Baseline (week 1); ongoing reporting through Follow-up (week 26).	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.
Modified Gait Efficacy Scale (mGES)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The mGES measures confidence in walking under challenging everyday conditions.
Montreal Cognitive Assessment (MoCA)	Baseline (week 1), Follow-up (week 26).	The MoCA evaluates cognitive function, including memory, attention, language, and executive functions. The MoCA consists of 30 points, with scores ranging from 0 to 30. Higher scores indicate better cognitive function, reflecting a better outcome.
New Freezing of Gait Questionnaire (NFOGQ)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The NFOGQ is a 9-item patient-reported instrument designed to assess the presence, severity, and impact of freezing of gait (FOG) in individuals with Parkinson's disease. Items are scored on a 5-point Likert scale ranging from 0 (absence or no impact) to 4 (severe or frequent impact).; The total score ranges from 0 to 28, with higher scores reflecting more severe and frequent freezing episodes.; Higher scores indicate worse freezing of gait symptoms, representing a worse outcome.
Daily Step Count	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The average number of steps taken per day will be recorded via wearable sensors.
Stride Time Variability	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	Stride-to-stride variability in walking rhythm will be derived from sensor data.
FACIT Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	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.
Timed Up and Go (TUG)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The TUG test assesses mobility, balance, and walking ability.
Mini-BESTest	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The Mini-BESTest evaluates dynamic balance across multiple domains of postural control.
Uninterrupted Walking Duration	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	Duration of uninterrupted walking bouts will be measured using wearable sensors.
Frailty Index (FI)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	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)
Foot placement kinematics	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	Three-dimensional motion capture will be used to evaluate gait and movement patterns, specicially the foot placement in relation to the centre of mass.
Two-Minute Walk Test (2MWT)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	This test measures functional exercise capacity by recording the distance walked in two minutes.
Visual Analogue Scale (VAS)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The VAS is used to assess subjective pain intensity or other symptom severity.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The MDS-UPDRS Part III is the motor examination component of the Unified Parkinson's Disease Rating Scale developed by the Movement Disorder Society. It assesses motor signs of Parkinson's disease across 18 items (e.g., tremor, rigidity, bradykinesia, posture, gait), each rated on a 5-point scale from 0 (normal) to 4 (severe impairment).; The total score ranges from 0 to 132. Higher scores indicate greater motor impairment, reflecting a worse outcome.
System Usability Scale (SUS)	Post-Training (week 14), Follow-up (week 26).	Participants' acceptability and satisfaction with the intervention will be assessed via the SUS. The SUS is a 10-item questionnaire that assesses user satisfaction and perceived usability of a system or intervention. Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).; Raw item scores are converted to a composite score ranging from 0 to 100. Higher scores indicate better perceived usability and greater user satisfaction, reflecting a better outcome.
Beta band activity	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	EEG (electroencephalogram) will be used to measure brain activity by recording electrical signals from the scalp. It will assess beta band activity during walking to examine changes in cortical involvement associated with gait and training.
Short Falls Efficacy Scale International (Short FES-I)	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The Short Falls Efficacy Scale International is a 7-item questionnaire assessing concern about falling during a range of physical and social activities. Each item is scored from 1 (not at all concerned) to 4 (very concerned), resulting in a total score ranging from 7 to 28. Higher scores indicate greater concern about falling, which reflects a worse outcome.
Color Trail Test (CTT)	Baseline (week 1), Follow-up (week 26).	The CTT assesses cognitive flexibility, visual attention, and processing speed. The CTT consists of two parts (CTT-1 and CTT-2), where participants are required to connect numbered circles in sequence, alternating between colours in the second part. Performance is measured by the time (in seconds) taken to complete each part. shorter completion times indicate better cognitive function, reflecting a better outcome.
Gait Symmetry	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	The symmetry of gait parameters between left and right limbs will be calculated.
EEG-EMG coherency in the beta band	Baseline (week 1), Post-Training (week 14), Follow-up (week 26).	Coherency between EEG and EMG signals in the beta frequency band will be assessed during walking to evaluate changes in corticomuscular connectivity associated with gait and training.
Physical Activity Enjoyment Scale (PACES)	Post-Training (week 14), Follow-up (week 26).	Participants' acceptability and satisfaction with the intervention will be assessed via the PACES. The PACES is an 18-item questionnaire designed to assess enjoyment of physical activity. Each item is rated on a 7-point Likert scale (e.g., from "I enjoy it" to "I hate it"), with some items reverse-scored.; The total score ranges from 18 to 126, with higher scores indicating greater enjoyment of physical activity, reflecting a better outcome.
Attitudes Towards Physical Activity	Post-Training (week 14), Follow-up (week 26).	The Exercise Self-Efficacy Scale (ESES) will assess changes in attitudes toward physical activity. The ESES is a 10-item questionnaire that assesses confidence in engaging in physical activity despite common barriers. Each item is rated from 1 (not at all confident) to 4 (always confident).; Total scores range from 10 to 40. Higher scores indicate greater confidence in the ability to exercise, reflecting a better outcome.
Participant experience	Post-Training (week 14), Follow-up (week 26).	Semi-structured qualitative interviews will explore participant experiences, perceived barriers, enablers, and reasons for withdrawal. As this is a qualitative assessment, no numerical scale applies, and responses will be analysed using thematic analysis methods.

Trial Locations

Locations (1)

Neuroscience Research Australia; 🇦🇺 Randwick, New South Wales, Australia