[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"equinovarus-foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:equinovarus-foot":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100575080","pilot-study-on-muscle-tendon-and-neural-changes-post-botulinum-toxin-injections-in-post-stroke-spastic-equinovarus-100575080",false,"NCT06767631","Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus","Exploratory, Longitudinal Study to Define Changes in Muscle, Tendon and Neural Properties After Botuline Neurotoxin Type A (BoNT) Treatment of Spastic Equinovarus in First-ever Stroke Patients: a Pilot Study.","Inclusion Criteria:\n\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* 2\\. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n* 3\\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n* 4\\. Pes equinovarus due to spasticity\n* 5\\. Clinical need for BoNT injection at the lower leg\n* 6\\. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago\n* 7\\. First-ever, unilateral stroke\n\nExclusion Criteria:\n\n* Musculoskeletal or other neurological problems affecting the lower limb\n* Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia\n* Cognitive problems that impede measurements\n* Severe co-morbidities\n* Irritated skin or open wounds where ultrasound will be placed\n* Pregnancy\n* Profound atrophy of the muscles in the target area(s) of injection\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n* The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase inhibitors and tubocurarine-like muscle relaxants ((cis)atracurium, rocuronium, suxamethonium, vecuronium). Therefore, patients on whom these medications are started during the course of the trail will be excluded.","ALL","40 Years","60 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"NA","Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment. Treatment outcomes and long-term responses to interventions can vary significantly between individual patients. Additionally, there is increasing concern about potential adverse effects on muscle morphology. Further research is essential to optimize treatment strategies and improve long-term outcomes in this population. Three-dimensional freehand ultrasound (3DfUS) and instrumented spasticity assessment (ISA) are two recently developed techniques that enable the evaluation of changes in muscle, tendon, and neural properties following BoNT injections for post-stroke spastic equinovarus. These methods hold promise for providing new insights into treatment effects. Before implementing these techniques in large-scale studies, a pilot study is required for accurate sample size calculations for a prospective observational study. This study includes a protocol for a non-blinded, non-randomized open-label longitudinal pilot study. The study was approved by the European Medicines Agency ( EU CT Number 2024-513158-32) by the University Hospitals Leuven ethical committee (ID S68672). Standard deviations and effect sizes of outcome measures obtained longitudinally with 3DfUS and ISA before and after BoNT injection into MG will inform sample size calculations for future research.",[27,28,29],"Stroke","Spasticity","Equinovarus Foot",[31,32,33,34,35],"Botulinum Toxins","stroke","Medial Gastrocnemius Muscle","Skeletal muscle morphology","muscle composition","RECRUITING","2026-04-28",{"date":39,"type":40},"2026-04-29","ACTUAL",{"date":42,"type":40},"2025-05-02",{"date":44,"type":21},"2027-12-31",{"name":46,"class":47},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100571913","evaluation-of-percutaneous-cryoneurotomy-compared-to-surgical-open-neurotomy-for-the-management-of-equinovarus-foot-deformity-in-patients-with-refractory-lower-limb-spasticity-after-stroke-100571913","NCT06726434","Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke","Evaluation of Percutaneous Cryoneurotomy Compared to Surgical Open Neurotomy for the Management of Equinovarus Foot Deformity in Patients With Refractory Lower Limb Spasticity After Stroke: a Multicenter, Randomized Controlled, Non-inferiority Trial","CRYOSTROKE","Inclusion Criteria:\n\n* Age ≥18 years old.\n* Patient with spastic equinovarus foot as a result of stroke in chronic phase (\\>6 months).\n* Patient with positive perineural motor block test with or without complete correction of spastic equinus and non-persistence of 40° equinus.\n* Patient eligible for surgical neurotomy for varus equinus foot.\n* Patient presenting no cognitive impairment or major depression (Mini Mental State Examination\\>20, Hospital Anxiety and Depression (HAD\\\u003C11)).\n* Absence of active psychosis or history of serious psychotic illness requiring hospitalization\n* Patient understanding and accepting the constraints of the study.\n* Patient covered by French national health insurance.\n* Patient who has given their written consent to the study after having received clear information.\n\nExclusion Criteria:\n\n* Patient with previous nerve procedures such as chemical neurolysis with alcohol, cryoneurotomy, or any surgery at the same anatomical site.\n* Patient with any neurological pathology different from the one responsible for the spasticity.\n* Patient with botulinum toxin in lower limb injection during the last 90 days before intervention.\n* Patient with anti-spastic treatment (baclofene) up 3 days before block test.\n* Patient with total deficit of valgus muscles.\n* Patient with equinus foot \\> 40° (retractions\u002Fankylosis).\n* Surgical and anesthetic contra-indications (severe uncontrolled coagulation disorder, active infection).\n* Cryoneurotomy contra-indications (cold intolerance, cryoglobulinemia, cryofibrinogenemia, Raynaud's phenomena, venous thromboemolism (\\\u003C 3 months if superficial, \\\u003C 6 months if deep), hypothyreosis, cold urticari, local disorders of blood supply, considerable anemia, cachexia, hypothermia, cancer disease, infection, coagulopathy…).).\n* Subject requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection (temporary or permanent guardianship and, subject to subordination), and finally patients in an emergency setting.\n* Pregnant woman, nursing mother, woman of childbearing potential not using effective contraception (hormonal\u002Fbarrier: oral, parenteral, percutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).","18 Years",{"count":59,"type":21},114,[24],"CRYOSTROKE study is designed :\n\n* to compare the efficacy and safety of percutaneous CryoNeurotomie (CN) versus surgical neurotomy (SN) on spasticity, 90 days after intervention, in post-stroke patients presenting with spastic equinovarus foot and,\n* to ensure that potential clinical effect\u002Fsafety remain stable within time, with a 12-month follow-up.",[27,29,63],"Refractory Lower Limb Spasticity",[65,66,67,68,69],"surgical neurotomy","CryoNeurotomy","spasticity","cryoneurolysis","percutaneous cryoneurolysis","2026-02-24",{"date":72,"type":40},"2026-02-25",{"date":74,"type":40},"2025-07-09",{"date":76,"type":21},"2029-06-09",{"name":78,"class":47},"Poitiers University Hospital",7,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100623939","improving-step-in-stroke-patients-100623939","NCT07403149","Improving STEP in Stroke Patients","Evaluating the Improvement of Stepping Quality by Using Adapted Shoes","I-STEP","Inclusion Criteria:\n\n1. Aged over 18 years\n2. With health insurance card \" carte vitale \" (being affiliated to the French security system) on \"ALD\" (Affection de longue durée) meaning reimbursement at a 100% rate\n3. With a past history of stroke (ischemic or hemorrhagic) with a Rankin score 2 to 4, once stabilized (no more improvement), at least 6 months after stroke onset\n4. Spasticity on one side of the body, with spastic walking, with tip-toeing gait, resulting in a \"mowing wheats-like\" movement of the leg as described in the French literature\n5. Patient had full medical examination prior to this research\n6. Informed and written consent of the participant.\n\nExclusion Criteria:\n\n1. Impossible to walk (wheel chair or bedridden)\n2. Diabetic foot\n3. Unhealed and\u002For painful foot injury\n4. Acquired deformity of a foot (osteophytosis, parrot beak on metatarso-phalangeal joint of the first ray, a bunion or hallux valgus, or hallux rigidus or stiffness of the big toe)\n5. Intercurrent disease that may interfere with the evaluation of the primary outcome (Parkinson's disease, peripheral neuropathy, Little's disease, significant hip or knee injury)",{"count":89,"type":21},58,[24],"Stroke is the leading cause of acquired disability in adults. Stroke causes death in 10% of patients, disability and functional handicap in 60% of cases. Sequelea of hemiplegia include spasticity resulting in great difficulty and slowness in walking, gait instability, increasing the risk of falls.\n\nDeambulation may need help (cane, crutch, tripod cane, walker). Lower limb spasticity includes hypertonia of extensors (gluteus maximus, quadriceps, posterior gastrocnemius) resulting in equinovarus. A neurology deficit may be present on ipsilateral lower limb flexors. Hence the patient walks with rubbing of the tip of the foot (tip-toeing gait), resulting in a \"mowing wheatslike\" movement of the leg as described in the French literature. Walking is then slowed down, unstable, with increased risk of falls.\n\nIn post stroke, during the period of rehabilitation and beyond, it is advisable to wear sports shoes although custom-made shoes improve walking and are reimbursed by the French social security system after prior agreement. Most of patients only wear conventional shoes.",[27,93,94,95,96,29],"Hemiplegia Following Ischemic Stroke","Disability Physical","Spasticity as Sequela of Stroke","Gluteus Maximus Muscle Atrophy",[27,98,99,100,101,102],"Hemiplegia","equinovarus","orthopedic shoes","REMARCHE® shoes","Walking performance","NOT_YET_RECRUITING","2026-02-04",{"date":106,"type":40},"2026-02-11",{"date":108,"type":21},"2026-03-01",{"date":110,"type":21},"2026-04-01",{"name":112,"class":47},"Assistance Publique - Hôpitaux de Paris"]