[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547752":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":41,"locations":51,"responsibleParty":69,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":23,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NEURO SWING AFO","EXPERIMENTAL","Participants will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING® system ankle joint. Following a previously developed algorithm, the stiffness will be individually selected from six different configurations tested during an optimization measurement directly after delivery of the new AFO. Thereafter, participants will use the optimized AFO with individualized stiffness at home for six weeks during the course of the study.",[13,14,15,16],"Device: NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)","Device: WalkOn Reaction® (Ottobock, Duderstadt)","Device: Matrix Max2® (TruLife, Dublin, Ireland)","Device: Matrix® (TruLife, Dublin, Ireland)",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)","stiffness-optimized custom-made spring-hinged AFO with the NEURO SWING® system ankle joint build in",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"WalkOn Reaction® (Ottobock, Duderstadt)","comparator: prefab spring-like AFO without hinge with a predefined stiffness (2.8 Nm\u002Fdegree).",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Matrix Max2® (TruLife, Dublin, Ireland)","comparator: prefab spring-like AFO without hinge with a predefined stiffness (1.4 Nm\u002Fdegree)",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Matrix® (TruLife, Dublin, Ireland)","comparator: prefab spring-like AFO without hinge with a predefined stiffness (0.6 Nm\u002Fdegree)",[9],[37],{"name":38,"affiliation":39,"role":40},"Frans Nollet, MD PhD","Amsterdam UMC, location AMC","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Merel-Anne Brehm, PhD","CONTACT","+ 3120 5664049","m.a.brehm@amsterdamumc.nl",{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},"Elza van Duijnhoven","+3120 5666915","e.vanduijnhoven@amsterdamumc.nl",[52],{"facility":53,"status":54,"city":55,"state":23,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Department of rehabilitation medicine Amsterdam UMC, location AMC","RECRUITING","Amsterdam","1105AZ","Netherlands","NL",{"type":60,"coordinates":61},"Point",[62,63],4.88969,52.37403,{"lat":63,"lon":62},[66],{"name":67,"role":44,"phone":68,"phoneExt":23,"email":46},"Merel Brehm, PhD","+ 31 20 5663669",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Merel Brehm","Principal Investigator",[74],{"name":75,"class":76},"FIOR & GENTZ","UNKNOWN","100547752","bidirectional-tuning-of-the-afo-stiffness-100547752",false,"NCT06412055","Bidirectional Tuning of the AFO Stiffness","Optimizing Gait with Bidirectional Tuning of the Ankle-foot Orthosis (AFO) Stiffness in People with Lower Leg Muscle Weakness","NEUROSWING","Inclusion Criteria:\n\n1. Age 18 years or older;\n2. Presence of plantar flexor weakness in at least one leg, determined as a score lower than 5 on the manual muscle testing scale (Medical Research Council- MRC) and\u002For inability to perform three single heel rises, with or without dorsiflexion weakness;\n3. Indicated for or using an AFO;\n4. Ability to walk 6-minutes consecutively (with assistive device, if necessary).\n\nExclusion Criteria:\n\n1. When wearing the AFO, not able to walk short bouts of 10m without walking aids, such as a walker;\n2. Foot deformities that do not fit in prefab spring-like AFOs;\n3. Weakness of the knee extensor muscles, for which a knee-ankle-foot orthosis is indicated.","ALL","18 Years",{"count":88,"type":89},10,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this pilot study with a pre-post design is to investigate the effects of separate individualization of the AFO stiffness towards plantar- and dorsiflexion in a spring-hinged AFO on walking compared to a spring-like AFO (3 types) having the same stiffness in both directions.\n\nPeople with a neuromuscular disease or nerve injury causing at least plantarflexor weakness (determined as the inability to perform 3 single heel rises), with an indication for or using an AFO, will be fitted with a new, custom-made spring-hinged AFO with the NEURO SWING® system ankle joint (Fior\\& Gentz, Lüneburg, Germany), of which the stiffness of ventral and dorsal compartment of this spring-hinged AFO will be individualized. For comparison, measurements will be performed with three different prefab spring-like AFOs with different stiffness levels (but which have a similar stiffness towards plantar and dorsiflexion), and the participants' current AFO if applicable, and shoes-only at baseline.\n\nThe main outcome parameters will be the maximal ankle plantarflexion angle, ankle angular velocity and knee flexion angle during the loading response, which will be measured using a 3D gait analysis. Secondary outcomes include other gait biomechanics, walking energy cost, walking speed, standing balance, perceived physical functioning and perceived walking ability.",[95],"Neuromuscular Disorders",[97,98,99,100,101,102,103],"Neuromuscular disorders","dorsiflexor and plantarflexor weakness","ankle-foot orthosis (AFO)","bidirectional stiffness tuning","Gait kinetics and kinematics","Walking energy cost","Perceived physical functioning","2025-02-03",{"date":106,"type":107},"2025-02-05","ACTUAL",{"date":109,"type":107},"2024-05-15",{"date":111,"type":89},"2025-02-01",{"name":5,"class":6},1]