[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100410927":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":35,"responsibleParty":55,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":26,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":26,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":38,"whyStopped":26,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Ioannina","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"LOW-HIGH VOLUME","ACTIVE_COMPARATOR","Initially a low volume of the drug (100IU botulinum toxin diluted in 2 ml) after a safe washout period of 6 months the same patients will be injected with a high volume (100IU botulinum toxin in 4 ml) of the drug.",[13,14],"Drug: Botulinum toxin","Diagnostic Test: gait analysis",{"label":16,"type":17,"description":18,"interventionNames":19},"HIGH-LOW VOLUME","EXPERIMENTAL","initially a high volume of the drug (100IU botulinum toxin diluted in 4 ml) after a safe washout period of 6 months the same patients will be injected with a low volume (100IU botulinum toxin in 2 ml) of the drug.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Botulinum toxin","The triceps surae along with the posterior tibialis muscle will be injected. The units that will be injected are the average being injected in our University Clinic. I.e. 50 units for each head of the gastrocnemius muscle- single injection site, 100 units for the soleus muscle- two injection sites and 50 units for the posterior tibialis muscle- single injection site.",[16,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DIAGNOSTIC_TEST","gait analysis","The gait analysis will be performed with two systems. A foot pressure sensitivity walkway (medicapteurs Win-Track), and an IMU network system (RehaGait Pro) using seven IMU's placed in specific anatomical positions. In combination those two systems can provide a wide range of spatiotemporal analytics of gait:",[16,9],[33,34],"medicapteurs Win-Track","RehaGait Pro",[36],{"facility":37,"status":38,"city":39,"state":26,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina","RECRUITING","Ioannina","45100","Greece","GR",{"type":44,"coordinates":45},"Point",[46,47],20.85187,39.66341,{"lat":47,"lon":46},[50],{"name":51,"role":52,"phone":53,"phoneExt":26,"email":54},"Avraam Ploumis","CONTACT","6932080701","aploumis@uoi.gr",{"type":56,"investigatorFullName":51,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Professor of Physical Medicine and Rehabilitation","100410927","phase-1-low-or-high-botox-dilution-for-the-hemiplegic-gait-100410927",false,"NCT04630873","Low or High Botox Dilution for the Hemiplegic Gait?","Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait","Inclusion Criteria:\n\n* equinovarus deformity\n* with an average 3 on Ashworth spasticity scale\n* able to walk indoors either freely or with a cane.\n\nExclusion Criteria:\n\n* patients suffering from any mental illness that would disturb the gait pattern\n* patients suffering from musculoskeletal diseases that overtly interfere with the gait","ALL","18 Years",{"count":68,"type":69},20,"ESTIMATED","INTERVENTIONAL",[72],"PHASE1","There is debate regarding the efficiency of different dilutions of Botulin toxin type A (BTX-A) injections. Some authors believe that highly diluted BTX-A injections achieve greater neuromuscular blockade resulting in higher spasticity reduction. On the other hand, other researchers suggest that there is no difference in spasticity decrease if either high or low volume toxin is being injected. Studies on this subject lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol. In an attempt to have a better understanding, a cross over study was designed. The material will be patients with spastic hemiparesis which will be treated with Botulin toxin at different dilutions. Gait analysis will be used for the evaluation of the Botulin toxin injection on gait improvement. To the best of our knowledge such a trial hasn't been performed yet.",[75],"Post Stroke Spastic Hemiplegia",[77,78],"stroke","hemiplegia","2024-12-04",{"date":81,"type":82},"2024-12-06","ACTUAL",{"date":84,"type":82},"2020-11-20",{"date":86,"type":69},"2025-08-01",{"name":5,"class":6},1]