[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548081":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":71,"studyPopulation":65,"armGroups":72,"interventions":84,"overallOfficials":94,"centralContacts":98,"locations":103,"responsibleParty":146,"collaborators":149,"id":152,"slug":65,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":65,"eligibilityCriteria":156,"healthyVolunteers":153,"sex":157,"minAge":65,"maxAge":65,"enrollmentInfo":158,"targetDuration":65,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":127,"whyStopped":65,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"Amsterdam UMC, location VUmc","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":57},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Self-reported quality of life","Self-reported quality of life will be determined using the Parkinson's Disease Questionnaire (PDQ-39)","Baseline (week 0), week 8, week 16, Post-intervention (week 24), week 32",{"measure":14,"description":15,"timeFrame":12},"General health-related quality of life","General health-related quality of life will be determined using the EuroQol 5 Dimensions 5 Level Survey (EQ-5D-5L)",{"measure":17,"description":18,"timeFrame":19},"Time in Freezing of Gait","Time in Freezing of Gait (i.e. frequency and duration of FoG) will be determined by the Cue2Walk medical device","Continuously from baseline (week 0) up to week 32",[21,24,28,31,33,36,39,42,45,48,51,54],{"measure":22,"description":23,"timeFrame":12},"Falls Efficacy","The level of concern about falling during various activities will be determined by the Falls Efficacy Scale International (FES-I)",{"measure":25,"description":26,"timeFrame":27},"Numbers of falls","The number of falls and near-falls will be determined with a weekly diary","Weekly from baseline (week 0) up to week 32",{"measure":29,"description":30,"timeFrame":12},"Freezing of Gait severity","Freezing of Gait severity will be determined by the New Freezing of Gait Questionnaire (NFOG-Q)",{"measure":29,"description":32,"timeFrame":12},"Freezing of Gait severity will be determined by the Patient Reported Outcomes for Freezing of Gait (PRO-FOG)",{"measure":34,"description":35,"timeFrame":12},"Independence in Activities of Daily Living","Independence in Activities of Daily Living will be determined by the Nottingham Extended Activities of Daily Living Index (NEADL)",{"measure":37,"description":38,"timeFrame":12},"Motor Aspects of Experiences of Daily Living","Motor Aspects of Experiences of Daily Living will be determined by MDS-UPDRS part II",{"measure":40,"description":41,"timeFrame":19},"Daily mobility","Daily mobility will be determined by the Cue2Walk step count",{"measure":43,"description":44,"timeFrame":12},"Mood","Mood will be determined by Hospital Anxiety and Depression Scale (HADS)",{"measure":46,"description":47,"timeFrame":12},"Gait-Specific Attentional Profile","Gait-Specific Attentional Profile will be determined by the Gait-Specific Attentional Profile questionnaire (G-SAP)",{"measure":49,"description":50,"timeFrame":12},"Acceptance of Illness","Acceptance of illness will be determined by the Chronic Illness Acceptance Questionnaire (CIAQ)",{"measure":52,"description":53,"timeFrame":12},"Caregiver burden","Caregiver burden will be determined by Zarit's Burden Interview Short Form (ZBI-12)",{"measure":55,"description":56,"timeFrame":12},"Patient experiences","We will use patient reported experience measures (PREMS) to quantify patient experiences regarding the care they receive during the intervention phase and we will record user experiences",[58],{"measure":59,"description":60,"timeFrame":61},"Resource Utilization","For the economic evaluation, resource utilization will be determined by a cost questionnaire","Baseline (week 0), week 8, week 16, Post-intervention (week 24)",{"allocation":63,"interventionModel":64,"interventionModelDescription":65,"primaryPurpose":66,"observationalModel":65,"timePerspective":65,"maskingInfo":67},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":68,"maskingDescription":65,"whoMasked":69},"SINGLE",[70],"OUTCOMES_ASSESSOR","Freezing of gait (FoG) is one of the most common and disabling motor symptoms of Parkinson's disease and is associated with poorer quality of life. However, current pharmacological or even surgical treatments do not address FoG adequately and innovative rehabilitation strategies are needed. Cueing is a proven strategy to overcome FoG episodes and an essential part in the management of FoG. The Cue2Walk, a Medical Device Class I CE-certified leg-worn device, addresses the debilitating effects of FoG episodes at home with 'smart cueing' by combining automatic detection of a freezing episode with manual or automatic rhythmic cues (auditory or vibro-tactile). This study aims to investigate the (cost-)effectiveness of the Cue2Walk device as compared to usual care. This study is a multicenter randomized clinical trial with 2 parallel groups (24-week intervention group and 24-week 'waiting list' group). After 24 weeks, an 8-week naturalistic follow-up will be implemented for the intervention group, while participants in the waiting list group will also receive the intervention, but for 8 weeks. Frequently repeated assessment of outcomes measures will be conducted.",[73,79],{"label":74,"type":75,"description":76,"interventionNames":77},"Intervention Group","EXPERIMENTAL","At-home use of the Cue2Walk",[78],"Device: Cue2Walk",{"label":80,"type":6,"description":81,"interventionNames":82},"Control Group","Usual Care (+ Waiting List)",[83],"Other: Usual Care",[85,90],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":65},"DEVICE","Cue2Walk","24 weeks of using of the Cue2Walk device in the own living environment + 8 weeks of naturalistic follow-up",[74],{"type":6,"name":91,"description":92,"armGroupLabels":93,"otherNames":65},"Usual Care","24 weeks of receiving usual care + 8 weeks of using of the Cue2Walk device in the own living environment",[80],[95],{"name":96,"affiliation":5,"role":97},"Erwin EH van Wegen, PhD","PRINCIPAL_INVESTIGATOR",[99],{"name":96,"role":100,"phone":101,"phoneExt":65,"email":102},"CONTACT","020-4440461","e.vanwegen@amsterdamumc.nl",[104,126],{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"Radboudumc","NOT_YET_RECRUITING","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":113,"coordinates":114},"Point",[115,116],5.85278,51.8425,{"lat":116,"lon":115},[119,122,123],{"name":120,"role":100,"phone":65,"phoneExt":65,"email":121},"Jorik Nonnekes, MD, PhD","Jorik.Nonnekes@radboudumc.nl",{"name":120,"role":97,"phone":65,"phoneExt":65,"email":65},{"name":124,"role":125,"phone":65,"phoneExt":65,"email":65},"Lotte van de Venis, PhD","SUB_INVESTIGATOR",{"facility":5,"status":127,"city":128,"state":129,"zip":130,"country":110,"countryCode":111,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"RECRUITING","Amsterdam","North Holland","1081HZ",{"type":113,"coordinates":132},[133,134],4.88969,52.37403,{"lat":134,"lon":133},[137,139,140,142,144],{"name":138,"role":100,"phone":101,"phoneExt":65,"email":102},"Erwin EH van Wegen, Dr.",{"name":96,"role":97,"phone":65,"phoneExt":65,"email":65},{"name":141,"role":125,"phone":65,"phoneExt":65,"email":65},"Matthijs van der Laan, MSc",{"name":143,"role":125,"phone":65,"phoneExt":65,"email":65},"Marc B. Rietberg, PhD",{"name":145,"role":125,"phone":65,"phoneExt":65,"email":65},"Vincent de Groot, Prof. dr.",{"type":97,"investigatorFullName":147,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":65,"oldOrganization":65},"Dr. Erwin E. H. van Wegen","Principal Investigator, Associate Professor Neurorehabilitation",[150],{"name":151,"class":6},"Radboud University Medical Center","100548081",false,"NCT06416345","Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease","Inclusion Criteria:\n\n* Diagnosis of Parkinson's disease according to UK Brain bank criteria\n* Daily Freezing of Gait\n* Hoehn-Yahr stage 2-4\n* Stable medication regime and\u002For DBS settings as determined by the treating neurologist\n* Ability to walk 5 minutes while unassisted by another person\n\nExclusion Criteria:\n\n* Participation in another clinical study\n* Use of a personal cueing device at home\n* Previous use of the Cue2Walk medical device\n* Presence of co-morbidities that would hamper participation\n* Cognitive impairment preventing understanding of therapeutic instructions (Montreal Cognitive Assessment (MoCA) Score \\\u003C16)","ALL",{"count":159,"type":160},84,"ESTIMATED","INTERVENTIONAL",[163],"NA","The majority of people with Parkinson's disease incur Freezing of Gait (FoG), which is not addressed adequately by medication. Cueing is a proven strategy to overcome FoG. The Cue2Walk is a device with automated detection of FoG and provision of rhythmic cues. In this study, the (cost-)effectiveness of the Cue2Walk device as compared to usual care is investigated.",[166],"Parkinson Disease",[168,169,170,171],"Parkinson's Disease","Freezing of Gait","(Smart) Cueing","Costeffectiveness","2026-03-12",{"date":174,"type":175},"2026-03-16","ACTUAL",{"date":177,"type":175},"2025-08-22",{"date":179,"type":160},"2027-12-01",{"name":5,"class":6},2]