[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646228":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":26,"overallStatus":78,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Pamukkale University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"rESWT + Physical Therapy","EXPERIMENTAL","Patients receive routine BoNT-A injection, followed by 3 weekly sessions of radial Extracorporeal Shock Wave Therapy (rESWT) and a 3-week conventional physical therapy program.",[13,14],"Device: Radial Extracorporeal Shock Wave Therapy (rESWT)","Other: Conventional Physical Therapy and Rehabilitation",{"label":16,"type":17,"description":18,"interventionNames":19},"Physical Therapy Alone","ACTIVE_COMPARATOR","Patients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Radial Extracorporeal Shock Wave Therapy (rESWT)","Applied 1 week after the routine Botulinum Toxin Type A (BoNT-A) injection. Patients receive 3 sessions (once a week for 3 weeks) of rESWT to the medial and lateral heads of the gastrocnemius muscle in the prone position with knee in full extension and ankle in neutral. Dose parameters: 2000 pulses per session, 5 Hz frequency, and 60 mJ (1 bar) energy level using a 15 mm transmitter head (calculated energy flux density: 0.340 mJ\u002Fmm²).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional Physical Therapy and Rehabilitation","A 3-week comprehensive rehabilitation program performed 2-3 hours per day, 5 days a week. The program includes passive\u002Factive range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-shifting, balance training, gait training, occupational therapy, and speech therapy based on individual patient needs.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Meltem G Akıncı, MD, Assistant Professor","CONTACT","+90 258 296 16 04","meltem_aytekin@hotmail.com",[38],{"facility":39,"status":26,"city":40,"state":40,"zip":41,"country":42,"countryCode":26,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation","Denizli","20160","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],29.0875,37.77417,{"lat":47,"lon":46},[50],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Meltem Gunes Akinci","Principal Investigator","100646228","extracorporeal-shock-wave-therapy-in-botulinum-toxin-treated-patients-with-post-stroke-ankle-plantar-flexor-spasticity-100646228",false,"NCT07695038","Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity","Effectiveness of Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Injection in Patients With Post-Stroke Ankle Plantar Flexor Spasticity: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosis of stroke according to the World Health Organization (WHO) (1989) definition.\n* Stroke diagnosis confirmed by magnetic resonance imaging (MRI).\n* Patients aged between 18 and 65 years.\n* Clinically stable condition after stroke.\n* Patients who have undergone routine Botulinum Toxin Type A (BoNT-A) injection to the gastrocnemius muscle.\n* Presence of ankle plantar flexor spasticity with a Modified Ashworth Scale (MAS) score of greater than or equal to 1 (MAS ≥ 1).\n\nExclusion Criteria:\n\n* Presence of fixed contracture at the ankle joint.\n* History of prior antispastic surgical procedures.\n* Changes in antispastic medication dosage or type within the last 6 months.\n* Active infection or malignancy at the application site.\n* Presence of a cardiac pacemaker.\n* Bleeding disorders or advanced vascular disease.\n* Pregnancy.\n* Presence of neuromuscular junction disease or motor neuron disease.\n* Known allergy or hypersensitivity to Botulinum Toxin Type A.\n* Current use of antibiotics.","ALL","18 Years","65 Years",{"count":66,"type":67},32,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. The main questions it aims to answer are:\n\n* Does adding rESWT to standard physical therapy significantly lower muscle spasticity in patients who have received BoNT-A, compared to receiving physical therapy alone after the injection?\n* Does combining rESWT with BoNT-A injection improve functional walking parameters (such as gait speed, cadence, and step length) and daily life independence more than the BoNT-A and physical therapy combination alone?\n* Can rESWT induce additional structural and flexibility improvements in the BoNT-A injected gastrocnemius muscle, as measured objectively by ultrasound imaging and strain elastography?\n\nResearchers will compare a group of participants receiving both rESWT and conventional physical therapy (Group 1) to a comparison group receiving only conventional physical therapy (Group 2) to see if rESWT provides additional clinical benefits. All participants in both groups will have already undergone routine BoNT-A injections one week prior to starting the study treatments.\n\nParticipants will:\n\n* Undergo a 3-week conventional physical therapy and rehabilitation program, consisting of 2 to 3 hours of therapy per day, 5 days a week.\n* Receive 3 weekly sessions of rESWT (2000 pulses per session applied to the calf muscles) if they are randomized into the rESWT group.\n* Attend clinical evaluation visits and objective assessment sessions-including high-tech computerized gait analysis and specialized musculoskeletal ultrasound imaging-before the treatment, at the end of the 3rd week, and at a 12-week follow-up.",[73,74,75,76,77],"Stroke","Post-stroke Spasticity of the Lower Limb","Post-Stroke Spasticity","Spasticity of the Plantar Flexors","Spasticity, Post-Stroke","NOT_YET_RECRUITING","2026-07-04",{"date":81,"type":82},"2026-07-10","ACTUAL",{"date":84,"type":67},"2026-07-20",{"date":86,"type":67},"2027-08-20",{"name":5,"class":6},1]