[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538841":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":105,"collaborators":108,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":25,"studyType":134,"phases":135,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Universiteit Antwerpen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum Toxin type A","ACTIVE_COMPARATOR","The BTX-A group will receive onabotulinumtoxinA (Botox®, Allergan) with mandatory muscles getting 300 units and optional muscles getting up to 100 additional units (maximum dose of 400 units) (14) delivered with a 27-gauge (0.45 mm) beveled needle. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.",[13],"Drug: Botulinum toxin type A",{"label":15,"type":10,"description":16,"interventionNames":17},"Dry Needling","For Dry Needling group solid, filiform non-beveled 0.30 mm caliber needles will be used. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.",[18],"Other: Dry Needling",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Botulinum toxin type A","Botulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Dry Needling is a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a mechanical disruption of dysfunctional endplates.",[15],[30],{"name":31,"affiliation":32,"role":33},"Pablo Herrero Gallego, PhD","Universidad de Zaragoza","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+34646168248","pherrero@unizar.es",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Clara Pujol Fuentes, Msc","+34661075990","clara.pujol.fisioterapeuta@gmail.com",[44,69,87],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Antwerp","Flanders","2000","Belgium","BE",{"type":52,"coordinates":53},"Point",[54,55],4.40026,51.22047,{"lat":55,"lon":54},[58,62,66,67],{"name":59,"role":36,"phone":60,"phoneExt":25,"email":61},"Wim Saeys, PT","+32496804347","wim.Saeys@uantwerpen.be",{"name":63,"role":36,"phone":64,"phoneExt":25,"email":65},"Bart Eeckhaut, PT","+32486543747","eeckhautbart@hotmail.com",{"name":59,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":63,"role":68,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":70,"status":45,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Jewish Rehabilitation Hospital","Montreal","Quebec","H7V 1R2","Canada","CA",{"type":52,"coordinates":77},[78,79],-73.58781,45.50884,{"lat":79,"lon":78},[82,86],{"name":83,"role":36,"phone":84,"phoneExt":25,"email":85},"Mindy F. Levin, PT","+972505204734","mindy.levin@mcgill.ca",{"name":83,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":88,"status":45,"city":89,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Hospital Clínico Universitario Lozano Blesa","Zaragoza","50009","Spain","ES",{"type":52,"coordinates":94},[95,96],-0.87734,41.65606,{"lat":96,"lon":95},[99,101,103,104],{"name":100,"role":36,"phone":37,"phoneExt":25,"email":38},"Pablo Herrero Gallego, PT",{"name":102,"role":36,"phone":41,"phoneExt":25,"email":42},"Clara Pujol Fuentes, PT",{"name":100,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":102,"role":68,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Dr. Pablo Herrero Gallego","Prof. Dr.",[109,111,113,116,118],{"name":110,"class":6},"Instituto de Investigación Sanitaria Aragón",{"name":112,"class":6},"McGill University",{"name":114,"class":115},"Instituto de Salud Carlos III","OTHER_GOV",{"name":117,"class":115},"Fonds de la Recherche en Santé du Québec",{"name":119,"class":6},"Research Foundation Flanders","100538841","phase-2-comparative-study-of-the-effects-of-dry-needling-and-botulinum-toxin-type-a-as-a-treatment-for-lower-limb-post-stroke-spasticity-100538841",false,"NCT06296082","Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity","Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial","STROKEPOC","Inclusion Criteria:\n\n1. aged 18-75 years.\n2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).\n3. first stroke.\n4. 0-12 months evolution.\n5. no previous BTX-A or DN treatment for spasticity.\n6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \\~30°.\n7. independent ambulation with or without aids.\n\nExclusion Criteria:\n\n1. medical conditions interfering with data interpretation.\n2. contraindications for BTX-A or DN treatment.\n3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.\n4. pregnant or breastfeeding.","ALL","18 Years","75 Years",{"count":132,"type":133},90,"ESTIMATED","INTERVENTIONAL",[136,137],"PHASE2","PHASE3","This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.",[140],"Stroke",[142,15,143,144,145,146,147,148],"Stroke [Mesh]","Muscle Spasticity [Mesh]","Botulinum Toxins [Mesh]","Tonic Stretch Reflex Threshold","Ultrasound imaging","Gait analysis","Quality of Life [Mesh]","2026-04-28",{"date":151,"type":152},"2026-05-04","ACTUAL",{"date":154,"type":152},"2024-09-01",{"date":156,"type":133},"2027-03-29",{"name":5,"class":6},3]