[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572419":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":16,"centralContacts":30,"locations":36,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":16,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":16,"enrollmentInfo":76,"targetDuration":16,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":39,"whyStopped":16,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BoNT injection","EXPERIMENTAL","The participants will first receive BoNT injection for their upper limb spasticity. Earliest three months after the injection they will undergo surgery.",[13],"Drug: BoNT Injections",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgery",null,[18],"Procedure: Tendon lengthening surgery",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":16},"PROCEDURE","Tendon lengthening surgery","The participants will first receive BoNT injections, earliest three months after they will undergo tendon lengthening surgery",[15],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":16},"DRUG","BoNT Injections","The dosage and number of injected muscles will vary depending on the degree and extent of spasticity. All patients had previous BoNT injections, one injection circle will be followed in this study.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":16,"email":35},"Therese Ramström, PhD","CONTACT","+46(0)761357416","therese.ramstrom@vgregion.se",[37],{"facility":38,"status":39,"city":40,"state":16,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Sahlgrenska University Hoispital","RECRUITING","Mölndal","43180","Sweden","SE",{"type":45,"coordinates":46},"Point",[47,48],12.01378,57.6554,{"lat":48,"lon":47},[51,54,58],{"name":32,"role":33,"phone":52,"phoneExt":53,"email":35},"+46761357416","0761357416",{"name":55,"role":33,"phone":56,"phoneExt":16,"email":57},"Hannes Granberg, MD","+46735763347","hannes.granberg@vgregion.se",{"name":59,"role":60,"phone":16,"phoneExt":16,"email":16},"Therese (CARE) Ramström, phd","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[64],{"name":65,"class":66},"Promobilia Foundation","OTHER","100572419","comparing-upper-limb-surgery-and-botulinum-toxin-for-spasticity-a-paired-design-study-100572419",false,"NCT06733025","Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study","The Effectiveness of Spasticity-correcting Upper Limb Surgery Versus Botulinum Toxin Injections in Patients With Upper Limb Spasticity: an Experimental Study With Paired Design","Inclusion Criteria:\n\n1. 18 years or above\n2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI\n3. Patients treated at least 6 months after the injury event\n4. Ongoing BoNT treatment in the UL\n5. A minimum of 3 months passed since the last BoNT injection\n6. At least two muscles in the hand and wrist were considered for treatment\n7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment\n8. For the surgery group, medically stable to undergo surgery\n9. No other severe UL injuries affecting the functional level\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[81],"NA","Spasticity is a common complication following central nervous system injuries. Left untreated, spasticity can lead to various complications, hindering activities of daily living and diminishing independence. Spasticity affecting the hand is particularly debilitating because it prevents prehension and grasp, which are critical factors for the ability to perform activities of daily living independently. Spasticity is described as one of the prominent secondary conditions in individuals with various disabilities.\n\nWhile Botulinum toxin(BoNT) injections are widely used for focal spasticity, surgical interventions remain underutilized despite promising long-term outcomes. Center for Advanced Reconstruction of Extremities(C.A.R.E), at the hand surgery department at Sahlgrenska University hospital in Gothenburg, Sweden is a multiprofessional team and advocates a stratified surgical algorithm based on residual motor function, aiming to optimize patient outcomes.\n\nThis open-label, non-randomized, paired study aims to compare the efficacy of spasticity-correcting upper limb surgery with BoNT injections in improving body function, activity, and participation in patients with upper limb spasticity. A total of 30 patients will undergo both interventions sequentially, allowing for within-patient comparisons. The sample size calculation is based on prior studies.\n\nAll patients with ongoing BoNT treatment who get referral to C.A.R.E and seem eligible for the study will be informed about the study and enrolment procedure. Eligible participants will undergo both treatments sequentially, with outcome assessments conducted before and after each intervention. The treatments will follow routine clinical care.\n\nThe primary outcome measure, Modified Ashworth Scale, will assess spasticity severity. Secondary outcomes will include measures of functional and activity changes specific to each treatment regimen.\n\nThis study aims to provide valuable insights into the comparative effectiveness of spasticity interventions, guiding treatment decisions for patients with upper limb spasticity.",[84,85,86,87],"Muscle Spasticity","Spinal Cord Injury","Stroke","Traumatic Brain Injuries",[89,90,91,92,93,94],"Muscle spasticity","spinal cord injury","stroke","traumatic brain injuries","tendon lengthening","Botulinum toxin injection","2025-09-16",{"date":97,"type":98},"2025-09-17","ACTUAL",{"date":100,"type":98},"2025-01-07",{"date":102,"type":78},"2029-06-29",{"name":5,"class":6},1]