Parkinson Disease (PD)StepuPNCT07057219
Steps Against the Burden of Parkinson's Disease
A study testing Exercise in people with Parkinson Disease (PD), run by The University of New South Wales at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jul 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Neuroscience Research Australia
Randwick, New South Wales, 2031
Matthew A Brodie, PhD, +61 449 886 272, a.m.brodie@unsw.edu.au
Yoshiro Okubo, PhD, +61 293991065 ext. 1065, y.okubo@neura.edu.au
About this study
Official title: StepuP: Steps Against the Burden of Parkinson's Disease
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.
Read more
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.
Read the detailed description
- 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:
- 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.
- Assess the extent to which gait improvements measured in the laboratory transfer to improvements in daily-life mobility.
- Identify the mechanisms that support or limit the transfer of training effects from lab-based gait improvements to real-world mobility.
- 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.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Exercise
- Keywords
- EEG, EMG, perturbation, VR, real-world gait, wearable device, gait, balance, falls
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called SDTT, Treadmill training, Gait training
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.
ExerciseOther
Also called SDTT+, VR, perturbation training, Treadmill training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Comfortable walking speed overground
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26)
Secondary outcomes (25)
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.
Measured: Retrospective report at Baseline (week 1); ongoing reporting through Follow-up (week 26).
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
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)
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Visual Analogue Scale (VAS)
The VAS is used to assess subjective pain intensity or other symptom severity.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Foot placement kinematics
Three-dimensional motion capture will be used to evaluate gait and movement patterns, specicially the foot placement in relation to the centre of mass.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Timed Up and Go (TUG)
The TUG test assesses mobility, balance, and walking ability.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Two-Minute Walk Test (2MWT)
This test measures functional exercise capacity by recording the distance walked in two minutes.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Mini-BESTest
The Mini-BESTest evaluates dynamic balance across multiple domains of postural control.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Modified Gait Efficacy Scale (mGES)
The mGES measures confidence in walking under challenging everyday conditions.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Short Falls Efficacy Scale International (Short FES-I)
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline (week 1), Follow-up (week 26).
Color Trail Test (CTT)
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.
Measured: Baseline (week 1), Follow-up (week 26).
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
New Freezing of Gait Questionnaire (NFOGQ)
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Daily Step Count
The average number of steps taken per day will be recorded via wearable sensors.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Uninterrupted Walking Duration
Duration of uninterrupted walking bouts will be measured using wearable sensors.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Stride Time Variability
Stride-to-stride variability in walking rhythm will be derived from sensor data.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Gait Symmetry
The symmetry of gait parameters between left and right limbs will be calculated.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
System Usability Scale (SUS)
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.
Measured: Post-Training (week 14), Follow-up (week 26).
Physical Activity Enjoyment Scale (PACES)
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.
Measured: Post-Training (week 14), Follow-up (week 26).
Attitudes Towards Physical Activity
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.
Measured: Post-Training (week 14), Follow-up (week 26).
Participant experience
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.
Measured: Post-Training (week 14), Follow-up (week 26).
Beta band activity
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
EEG-EMG coherency in the beta band
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.
Measured: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start9 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroscience Research Australia, VU University of Amsterdam, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Shake it up Australia Foundation, Tel Aviv Medical Center
- Responsible party
- Principal investigator, Yoshiro Okubo, The University of New South Wales
- Investigators
- Matthew Brodie, PhD, Study chair, University of New South WalesYoshiro Okubo, PhD, Principal investigator, Neuroscience Research Australia, University of New South WalesDaniel Chan, PhD, MD, Principal investigator, University of New South WalesLuca Modenese, PhD, Principal investigator, University of New South WalesFrederic von Wegner, PhD, MD, Principal investigator, University of New South WalesPhu Hoang, PhD, MD, Principal investigator, Neuroscience Research AustraliaHusna Razee, PhD, Principal investigator, University of New South WalesPaulo Silva Pelicioni, PhD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057219
- Sponsor's protocol ID
- iRECS5114
- Other IDs
- 2022885
- Acronym
- StepuP
- Status last verified
- Jul 2025
- First submitted
- 19 May 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The pseudonymized personal dataset corresponding to study participants who have opted in at the time of consent
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StepuP: Steps Against the Burden of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07057219
- Acronym / sponsor ID
- StepuP / iRECS5114
- Conditions
- Parkinson Disease (PD)
- Keywords
- EEG, EMG, perturbation, VR, real-world gait, wearable device, gait, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Neuroscience Research Australia, VU University of Amsterdam, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Shake it up Australia Foundation, Tel Aviv Medical Center
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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:
- 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.
- Assess the extent to which gait improvements measured in the laboratory transfer to improvements in daily-life mobility.
- Identify the mechanisms that support or limit the transfer of training effects from lab-based gait improvements to real-world mobility.
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Speed-dependent treadmill training (SDTT) | Active comparator | Other: ExerciseSDTT 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. |
| SDTT+ perturbations + VR triggered adaptations | Experimental | Other: ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: SDTT, Treadmill training, Gait trainingSDTT 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 | Speed-dependent treadmill training (SDTT) |
| ExerciseAlso: SDTT+, VR, perturbation training, Treadmill trainingThe 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 | SDTT+ perturbations + VR triggered adaptations |
Primary outcome
Gait speed
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26)
Comfortable walking speed overground
25 secondary outcomes
Fall Events
Time frame: Retrospective report at Baseline (week 1); ongoing reporting through Follow-up (week 26).
EuroQol 5-Dimension (EQ-5D) Questionnaire
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Frailty Index (FI)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
FACIT Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Visual Analogue Scale (VAS)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Foot placement kinematics
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Timed Up and Go (TUG)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Two-Minute Walk Test (2MWT)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Mini-BESTest
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Modified Gait Efficacy Scale (mGES)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Short Falls Efficacy Scale International (Short FES-I)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (week 1), Follow-up (week 26).
Color Trail Test (CTT)
Time frame: Baseline (week 1), Follow-up (week 26).
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS Part III)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
New Freezing of Gait Questionnaire (NFOGQ)
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Daily Step Count
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Uninterrupted Walking Duration
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Stride Time Variability
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Gait Symmetry
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
System Usability Scale (SUS)
Time frame: Post-Training (week 14), Follow-up (week 26).
Physical Activity Enjoyment Scale (PACES)
Time frame: Post-Training (week 14), Follow-up (week 26).
Attitudes Towards Physical Activity
Time frame: Post-Training (week 14), Follow-up (week 26).
Participant experience
Time frame: Post-Training (week 14), Follow-up (week 26).
Beta band activity
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
EEG-EMG coherency in the beta band
Time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Yes. The pseudonymized personal dataset corresponding to study participants who have opted in at the time of consent
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Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study of Investigational Agents in Participants With Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Brodie, PhD study chair
University of New South Wales
Yoshiro Okubo, PhD principal investigator
Neuroscience Research Australia, University of New South Wales
Daniel Chan, PhD, MD principal investigator
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Parkinson Disease (PD), run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew A Brodie, PhD (+614 4988 6272, a.m.brodie@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Baseline (week 1), Post-Training (week 14), Follow-up (week 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.