[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597340":3},{"organization":4,"outcomesModule":7,"designInfo":107,"detailedDescription":118,"studyPopulation":112,"armGroups":119,"interventions":131,"overallOfficials":145,"centralContacts":176,"locations":185,"responsibleParty":204,"collaborators":207,"id":217,"slug":112,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":112,"enrollmentInfo":226,"targetDuration":112,"studyType":229,"phases":230,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":187,"whyStopped":112,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"fullName":5,"class":6},"The University of New South Wales","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":93},[9],{"measure":10,"description":11,"timeFrame":12},"Gait speed","Comfortable walking speed overground","Baseline (week 1), Post-Training (week 14), Follow-up (week 26)",[14,18,22,25,28,31,34,37,40,43,46,49,53,56,59,62,65,68,71,74,78,81,84,87,90],{"measure":15,"description":16,"timeFrame":17},"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.","Retrospective report at Baseline (week 1); ongoing reporting through Follow-up (week 26).",{"measure":19,"description":20,"timeFrame":21},"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.","Baseline (week 1), Post-Training (week 14), Follow-up (week 26).",{"measure":23,"description":24,"timeFrame":21},"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:\n\nNon-frail (0 criteria met) Pre-frail (1-2 criteria met) Frail (3 or more criteria met)",{"measure":26,"description":27,"timeFrame":21},"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.",{"measure":29,"description":30,"timeFrame":21},"Visual Analogue Scale (VAS)","The VAS is used to assess subjective pain intensity or other symptom severity.",{"measure":32,"description":33,"timeFrame":21},"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.",{"measure":35,"description":36,"timeFrame":21},"Timed Up and Go (TUG)","The TUG test assesses mobility, balance, and walking ability.",{"measure":38,"description":39,"timeFrame":21},"Two-Minute Walk Test (2MWT)","This test measures functional exercise capacity by recording the distance walked in two minutes.",{"measure":41,"description":42,"timeFrame":21},"Mini-BESTest","The Mini-BESTest evaluates dynamic balance across multiple domains of postural control.",{"measure":44,"description":45,"timeFrame":21},"Modified Gait Efficacy Scale (mGES)","The mGES measures confidence in walking under challenging everyday conditions.",{"measure":47,"description":48,"timeFrame":21},"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.",{"measure":50,"description":51,"timeFrame":52},"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.","Baseline (week 1), Follow-up (week 26).",{"measure":54,"description":55,"timeFrame":52},"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.",{"measure":57,"description":58,"timeFrame":21},"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).\n\nThe total score ranges from 0 to 132. Higher scores indicate greater motor impairment, reflecting a worse outcome.",{"measure":60,"description":61,"timeFrame":21},"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).\n\nThe total score ranges from 0 to 28, with higher scores reflecting more severe and frequent freezing episodes.\n\nHigher scores indicate worse freezing of gait symptoms, representing a worse outcome.",{"measure":63,"description":64,"timeFrame":21},"Daily Step Count","The average number of steps taken per day will be recorded via wearable sensors.",{"measure":66,"description":67,"timeFrame":21},"Uninterrupted Walking Duration","Duration of uninterrupted walking bouts will be measured using wearable sensors.",{"measure":69,"description":70,"timeFrame":21},"Stride Time Variability","Stride-to-stride variability in walking rhythm will be derived from sensor data.",{"measure":72,"description":73,"timeFrame":21},"Gait Symmetry","The symmetry of gait parameters between left and right limbs will be calculated.",{"measure":75,"description":76,"timeFrame":77},"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).\n\nRaw 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.","Post-Training (week 14), Follow-up (week 26).",{"measure":79,"description":80,"timeFrame":77},"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.\n\nThe total score ranges from 18 to 126, with higher scores indicating greater enjoyment of physical activity, reflecting a better outcome.",{"measure":82,"description":83,"timeFrame":77},"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).\n\nTotal scores range from 10 to 40. Higher scores indicate greater confidence in the ability to exercise, reflecting a better outcome.",{"measure":85,"description":86,"timeFrame":77},"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.",{"measure":88,"description":89,"timeFrame":21},"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.",{"measure":91,"description":92,"timeFrame":21},"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.",[94,98,101,104],{"measure":95,"description":96,"timeFrame":97},"Fracture History","The number and type of fractures sustained in the 12 months prior to baseline will be recorded.","Baseline (week 1).",{"measure":99,"description":100,"timeFrame":21},"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.\n\nChanges in medication will be categorised (e.g., dosage adjustments), and the number of participants with any change in medication will be reported.",{"measure":102,"description":103,"timeFrame":52},"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.\n\nThe number and percentage of participants using walking aids will be reported at each time point.",{"measure":105,"description":106,"timeFrame":97},"Hand Grip Strength","Grip strength will be assessed using a hand dynamometer as a proxy for overall strength and frailty.",{"allocation":108,"interventionModel":109,"interventionModelDescription":110,"primaryPurpose":111,"observationalModel":112,"timePerspective":112,"maskingInfo":113},"RANDOMIZED","PARALLEL","A randomised controlled trial","BASIC_SCIENCE",null,{"masking":114,"maskingDescription":112,"whoMasked":115},"DOUBLE",[116,117],"INVESTIGATOR","OUTCOMES_ASSESSOR","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.\n\nii. Objectives\n\nThe objectives of the StepuP project are to:\n\n1. 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.\n2. Assess the extent to which gait improvements measured in the laboratory transfer to improvements in daily-life mobility.\n3. Identify the mechanisms that support or limit the transfer of training effects from lab-based gait improvements to real-world mobility.\n4. 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.\n\nAchieving 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.\n\niii. Endpoints This trial will evaluate the effects of treadmill training with and without perturbations on gait performance and neural correlates in people with PD.\n\nPrimary endpoint:\n\n\\> Change in gait speed under controlled treadmill conditions.\n\nSecondary endpoints:\n\n* Clinical outcomes: Changes in motor symptoms and function measured through clinical assessments.\n* Kinematic outcomes: Changes in gait parameters such as step length and variability from baseline to follow-up.\n* Neurophysiological outcomes: EEG and EMG markers, including changes in EEG beta power and EEG-EMG coherence.\n\nExploratory endpoints:\n\n* Real-world gait metrics assessed via wearable sensors.\n* Gait self-efficacy assessed with validated questionnaires to examine psychological influences on transfer.\n\nThese outcomes will help identify how and for whom treadmill training leads to meaningful, lasting improvements in mobility.",[120,126],{"label":121,"type":122,"description":123,"interventionNames":124},"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.",[125],"Other: Exercise",{"label":127,"type":128,"description":129,"interventionNames":130},"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.",[125],[132,139],{"type":6,"name":133,"description":123,"armGroupLabels":134,"otherNames":135},"Exercise",[121],[136,137,138],"SDTT","Treadmill training","Gait training",{"type":6,"name":133,"description":129,"armGroupLabels":140,"otherNames":141},[127],[142,143,144,137,138],"SDTT+","VR","perturbation training",[146,150,154,156,158,160,163,165,167,170,172,174],{"name":147,"affiliation":148,"role":149},"Matthew Brodie, PhD","University of New South Wales","STUDY_CHAIR",{"name":151,"affiliation":152,"role":153},"Yoshiro Okubo, PhD","Neuroscience Research Australia, University of New South Wales","PRINCIPAL_INVESTIGATOR",{"name":155,"affiliation":148,"role":153},"Daniel Chan, PhD, MD",{"name":157,"affiliation":148,"role":153},"Luca Modenese, PhD",{"name":159,"affiliation":148,"role":153},"Frederic von Wegner, PhD, MD",{"name":161,"affiliation":162,"role":153},"Phu Hoang, PhD, MD","Neuroscience Research Australia",{"name":164,"affiliation":148,"role":153},"Husna Razee, PhD",{"name":166,"affiliation":148,"role":153},"Paulo Silva Pelicioni, PhD",{"name":168,"affiliation":169,"role":153},"Vicki Miller","Shake it up Australia Foundation",{"name":171,"affiliation":162,"role":153},"Carolyn Sue, PhD, MD",{"name":173,"affiliation":148,"role":153},"Martin Ostrowski, PhD",{"name":175,"affiliation":162,"role":153},"Mayna Ratanapongleka",[177,182],{"name":178,"role":179,"phone":180,"phoneExt":112,"email":181},"Matthew A Brodie, PhD","CONTACT","+614 4988 6272","a.m.brodie@unsw.edu.au",{"name":151,"role":179,"phone":183,"phoneExt":112,"email":184},"+61 293991065","y.okubo@neura.edu.au",[186],{"facility":162,"status":187,"city":188,"state":189,"zip":190,"country":191,"countryCode":192,"cosmosGeoPoint":193,"geoPoint":198,"contacts":199},"RECRUITING","Randwick","New South Wales","2031","Australia","AU",{"type":194,"coordinates":195},"Point",[196,197],151.24895,-33.91439,{"lat":197,"lon":196},[200,202],{"name":178,"role":179,"phone":201,"phoneExt":112,"email":181},"+61 449 886 272",{"name":151,"role":179,"phone":183,"phoneExt":203,"email":184},"1065",{"type":153,"investigatorFullName":205,"investigatorTitle":206,"investigatorAffiliation":5,"oldNameTitle":112,"oldOrganization":112},"Yoshiro Okubo","Conjoint Senior Lecturer",[208,209,211,213,215],{"name":162,"class":6},{"name":210,"class":6},"VU University of Amsterdam",{"name":212,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"name":169,"class":214},"UNKNOWN",{"name":216,"class":6},"Tel Aviv Medical Center","100597340",false,"NCT07057219","Steps Against the Burden of Parkinson's Disease","StepuP: Steps Against the Burden of Parkinson's Disease","StepuP","Inclusion Criteria:\n\n1. Diagnosis of PD according to the MDS Criteria\n2. Hoehn and Yahr stages I to III;\n3. Movement Disorder Society-sponsored version of the Unified Parkinson Disease Rating Scale (MDS-UPDRS) gait sub-score of 1 or more\n4. Signed informed consent to participation\n\nExclusion Criteria:\n\n* Any known general health condition likely to interfere with or to pose a contraindication to non-medically supervised physical exercise.\n* Moderate or severe depression (BDI-II ≥18)\n* Cognitive impairment which may preclude the possibility to provide a fully informed consent to enrolment.\n* Linguistic comprehension capacity less than 75% in ordinary conversation\n* Severe psychiatric comorbidity which may interfere with compliance to the study protocol\n* History of or current status of substance dependency\n* Unable to walk less than 1 floor\n* Thoracic pain in the last 4 weeks\n* Currently enrolled in other interventional studies\n* Implanted Deep Brain Stimulation device","ALL","18 Years",{"count":227,"type":228},42,"ESTIMATED","INTERVENTIONAL",[231],"NA","Parkinson's Disease Treadmill Training RCT Summary\n\nParkinson'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.\n\nThis 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.\n\nIn 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.\n\nBiomechanical 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.\n\nRecognising 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.",[234],"Parkinson Disease (PD)",[236,237,238,143,239,240,241,242,243],"EEG","EMG","perturbation","real-world gait","wearable device","gait","balance","falls","2025-07-13",{"date":246,"type":247},"2025-07-17","ACTUAL",{"date":249,"type":247},"2025-07-09",{"date":251,"type":228},"2026-11-30",{"name":5,"class":6},1]