[{"data":1,"prerenderedAt":286},["ShallowReactive",2],{"content-site-settings":3,"content-\u002Fabout":73,"recruitment-data":207},{"id":4,"extension":5,"meta":6,"stem":71,"__hash__":72},"dataFiles\u002Fdata\u002Fsite.json","json",{"en":7},{"siteDetails":8,"cookieControl":12,"siteLogo":16,"mainNav":21,"preNav":37,"stickyNav":60,"footerContent":61},{"organisationName":9,"siteName":10,"siteUrl":11},"University of Oxford","SPELL study site","https:\u002F\u002Fspell-study.org",{"cookieModalTitle":13,"cookieModalText":14,"nonNecessaryCookiesUsed":15},"Cookies used on this site","This website only uses non-necessary cookies to remember where you are in the process and to learn about how people view the information. We do NOT use cookies that directly identify anyone. For the best experience please click Accept all below.",true,{"url":17,"alt":18,"width":19,"height":20},"spell-logo.svg","Home",160,null,[22,24,27,31,34],{"title":18,"url":23},"\u002F",{"title":25,"url":26},"Taking part","\u002Ftaking-part",{"title":28,"url":29,"target":30,"external":30},"About the study","\u002Fabout\u002F",false,{"title":32,"url":33},"Resources","\u002Fresources\u002F",{"title":35,"url":36,"target":30,"external":30},"Contact","\u002Fcontact\u002F",[38,43,46,50,53,57],{"id":39,"url":40,"title":41,"visibleFrom":42},"prenav-1","https:\u002F\u002Fredcap-ndormssitu.octru.ox.ac.uk\u002F","Enrolment & Data Collection","md",{"id":44,"url":40,"title":45,"visibleBelow":42},"prenav-2","REDCap",{"id":47,"url":48,"title":49,"visibleFrom":42},"prenav-3","https:\u002F\u002Fspell-info.digitrial.com\u002F","Patient Information Tool",{"id":51,"url":48,"title":52,"visibleBelow":42},"prenav-4","PIT",{"id":54,"url":55,"title":56,"visibleFrom":42},"prenav-5","https:\u002F\u002Fspell-app.digitrial.com\u002F","Intervention App",{"id":58,"url":55,"title":59,"visibleBelow":42},"prenav-6","App",[],{"footerLogo":62,"footerCol1":67,"footerCol2":68,"footerCol3":69,"additionalInfo":70},{"url":63,"alt":64,"width":65,"height":66},"spell-footer-logo.svg","MEDICAL TRIAL study logo",352,180,"**Address**\nSITU\nNDORMS\nUniversity of Oxford\nBotnar Research Centre\nWindmill Road\nOxford OX3 7LD","**Email**\\\nspell@ndorms.ox.ac.uk\n\n**Telephone**\\\n07584155471","[Privacy policy](\u002Fprivacy)\n[Cookie policy](\u002Fcookies)\n[Accessibility statement](\u002Faccessibility)\n[Site map](\u002Fsite-map)","The SPELL Study is funded by the National Institute for Health and Care Research (Funder Reference: \nNIHR135131). The views expressed are those of the authors and are not intended to be representative of the views of the funder, sponsor or other participating organisations.\n\nThe information contained in this website is for general information about the SPELL Study and is provided by the University of Oxford (Surgical Intervention Trials Unit).\n\n**This is a digitrial site made by morph.co.uk.**","data\u002Fsite","n7R0uHuB_3X-D39IHxIXmQpl3LUaOmnvujnx1KJhMls",{"id":74,"title":28,"body":20,"description":20,"extension":5,"meta":75,"navigation":15,"path":203,"seo":204,"stem":205,"__hash__":206},"contentPages\u002Fpages\u002Fabout.en.json",{"pageTitle":28,"pageMetadata":76,"page_content":77},{"htmlTitle":28,"htmlDesc":28},[78,90,100,141,148,187,195],{"type":79,"title":80,"text":81,"image":82,"settings":87,"sectionSettings":89},"page_header","# About the study","Clinical effectiveness of a child-specific dynamic stretching programme, compared to usual care, for ambulant children with spastic cerebral palsy (SPELL trial): a parallel group randomised controlled trial.",{"url":83,"alt":84,"width":85,"height":86},"spell-header-image-2.svg","",1000,655,{"imgPosition":88},"bottom",{"sectionLabel":28},{"type":91,"settings":92,"title":94,"text":95,"image":96,"sectionSettings":98},"text_and_image",{"imgWidth":93,"imgPosition":88},"half-width","## Aim of the study","The aim of this trial is to assess if an exercise programme to stretch the muscles of children with cerebral palsy is better than usual NHS physiotherapy treatment.",{"url":97,"alt":84,"width":85,"height":86},"spell-content-image-19.svg",{"sectionLabel":99},"Aim of the study",{"type":101,"settings":102,"text":106,"cards":107,"sectionSettings":139},"text_and_cards",{"headerLevel":103,"headerFontSize":103,"maxCardsPerRow":103,"wholeClickable":30,"cardTheme":104,"alignCards":105,"alignCardContent":105},"3","primary","center","## Information about the study",[108,115,120,124,129,134],{"type":109,"icon":110,"title":113,"summary":114},"card_icon_text",{"iconName":111,"iconSize":112},"content-edit","xl","Study design","Two-group, pragmatic, superiority, parallel group, multicentre randomised controlled trial with an imbedded internal pilot.",{"type":109,"icon":116,"title":118,"summary":119},{"iconName":117,"iconSize":112},"content-cross","Timescales","Planned trial period is 44 months. Recruitment is expected to last for 20 months.",{"type":109,"icon":121,"title":122,"summary":123},{"iconName":117,"iconSize":112},"Intervention","Dynamic stretching exercise programme: Participants receive an individually tailored dynamic stretching programme overseen by a physiotherapist via 6 one-to-one sessions over 16 weeks.",{"type":109,"icon":125,"title":127,"summary":128},{"iconName":126,"iconSize":112},"content-person","Target population","Children aged 4-11 years with a diagnosis of spastic CP (bilateral or unilateral) (8) GMFCS levels I III who are able to comply with assessment procedures and exercise programme with or without support by their carer.",{"type":109,"icon":130,"title":132,"summary":133},{"iconName":131,"iconSize":112},"content-pie-chart","Outcome measures","Functional mobility at 6 months measured using the patient\u002Fparent reported GOAL (Gait Outcomes Assessment List) questionnaire",{"type":109,"icon":135,"title":137,"summary":138},{"iconName":136,"iconSize":112},"content-seedling","Study funder and sponsor","The trial is funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme. The sponsor is University of Oxford, Research Governance, Ethics & Assurance Team (RGEA).",{"sectionLabel":140},"Information about the Study",{"type":142,"text":143,"componentName":144,"sectionSettings":145},"text_and_component","## Enrolment curve","StudyRecruitmentChart",{"textAlign":146,"sectionLabel":147},"left","Current enrolment curve",{"type":101,"settings":149,"text":151,"cards":152,"sectionSettings":185},{"headerLevel":103,"headerFontSize":150,"maxCardsPerRow":103,"wholeClickable":30,"cardTheme":104,"numberedCards":30,"alignCards":146,"alignCardContent":146},"4","## Core Trial Team",[153,160,165,170,175,180],{"type":154,"image":155,"title":158,"summary":159},"card_image_text",{"url":156,"width":157,"height":157},"tim-theologis.jpg",450,"Tim Theologis","**Co-Chief Investigator**\n\nProf Tim Theologis is a Senior Research Fellow at Oxford University and an honorary Consultant Orthopaedic Surgeon at Oxford University Hospitals. He looks after children with orthopaedic conditions and is involved in the teaching of medical students, the supervision of postgraduate degrees and the training of orthopaedic residents. He has an active academic interest in children’s orthopaedics and is leading multi-centre clinical research studies.",{"type":154,"image":161,"title":163,"summary":164},{"url":162,"width":157,"height":157},"sally-hopewell.jpg","Professor Sally Hopewell","**Co-Chief Investigator**\n\nMy key areas of research expertise are in the design, conduct and transparent reporting of randomized trials and systematic reviews. I am involved in leading the design and delivery of a number of clinical trials within the OCTRU portfolio. I am also co-chief investigator on the SPELL and ROBUST trials and on several other NIHR funded trials in the areas of rehabilitation and musculoskeletal sciences.",{"type":154,"image":166,"title":168,"summary":169},{"url":167,"width":157,"height":157},"catherine.jpg","Catherine Barry","**Paediatric Research Physiotherapist**\n\nI joined the Surgical Intervention Trials Unit (SITU-NDORMS) as a Paediatric Research Physiotherapist working on the SPELL and ROBUST trials. Funded by the NIHR Health Technology Assessment programme, the trials investigate the clinical effectiveness of physiotherapy interventions for children and young people with cerebral palsy. \n\nAfter graduating with a BSc (Hons) in Physiotherapy from the University of Southampton in 1996,  I specialised as a Paediatric Physiotherapist. I developed a specialist interest in the musculoskeletal management of cerebral palsy, including rehabilitation following lower limb multi-level orthopaedic surgery, working in both Melbourne and Oxford Children’s Hospital.  My most recent clinical role was as an Extended Scope Physiotherapist (in paediatric neuro-orthopaedics), which I combined with the role of Children’s Musculoskeletal Therapy Team Lead at The Oxford University Hospitals NHS Foundation Trust.",{"type":154,"image":171,"title":173,"summary":174},{"url":172,"width":157,"height":157},"helen.jpg","Helen Wood","**Physiotherapist (Research)**\n\nI joined SITU in 2023 as a research physiotherapist to work on the SPELL and ROBUST clinical trials.  I continue to work clinically alongside this.  \n\nPrior to taking up this role I worked clinically in variety of sectors, specialising initially in Adult and Paediatric MSK.  I completed an MSc in Paediatric Physiotherapy at UCL before moving to Oxford where I spent time working in both the paediatric acute, and MSK\u002Forthopaedic teams.  Here, I was fortunate to complete a research internship, funded by the Oxford Biomedical Research Centre.",{"type":154,"image":176,"title":178,"summary":179},{"url":177,"width":157,"height":157},"jo.jpg","Jo O’Mahoney","**Clinical Trial Manager**\n\nI joined SITU in November 2021 to work as a trial manager on the paediatric orthopaedic CPinBOSS study. CPinBOSS is a cohort study measuring the number of patients with cerebral palsy eligible for single event multi level surgery (SEMLS) in the UK. This study is led by Chief Investigator Tim Theologis and is now in follow up. In addition, I have recently started working on the set up of another paediatric study investigating the role of USS and MRI in diagnosing bone infection - PIC Bone, which is also led by Tim Theologis and Dan Perry (joint Chief Investigators). \r\n\r\nMy background is in psychology in which I have achieved a BSc (Hons) degree, followed by a MSc in Foundations of Clinical Psychology in 2008. I then worked as a research worker on a number of mental health research projects at St George's University of London and King's College Institute of Psychiatry before I returned to my hometown of Oxford where I joined NDORMS in 2014 as a research coordinator. In this role I assisted with the set up and delivery of both adult and paediatric musculoskeletal research projects. This is where I discovered my passion for paediatric orthopaedic research, leading me to my current role. ",{"type":154,"image":181,"title":183,"summary":184},{"url":182,"width":157,"height":157},"debbie-jewell.jpg","Debbie Jewell","**Clinical Trials Coordinator**\n\nI joined the Surgical Intervention Trials Unit (SITU) in April 2024 as a Clinical Trial Coordinator, where I currently support the SPELL and ROBUST Trials, as well as the PIC Bone Study. \n\nPrior to joining SITU, I worked as a Clinical Research Assistant at Milton Keynes University Hospital NHS Foundation Trust. My background is in Psychology, in which I have achieved a BSc (hons) degree in 2018, followed by a MSc in Psychological Research Methods in 2020.",{"sectionLabel":186},"Study Team",{"type":91,"settings":188,"title":189,"text":190,"image":191,"sectionSettings":193},{"imgWidth":93,"imgPosition":88},"## Co-Applicants","* Prof Tim Theologis (University of Oxford)\n* Prof Sally Hopewell (University of Oxford)\n* Prof Jeremy Parr (Newcastle University)\n* Dr Morag Andrew (Newcastle upon Tyne NHS Foundation Trust)\n* Dr David Keene (University of Exeter)\n* Dr Jennifer Ryan (Royal College of Surgeons in Ireland)\n* Dr Lesley Katchburian (UCL Great Ormond Street Institute of Child Health)\n* Mrs Rachel Rapson (Torbay and South Devon NHS Foundation Trust)\n* Dr Ines Rombach (Sheffield University)\n* Dr Beth Fordham (University of Oxford)\n* Mr Gregory Firth (Royal London Hospital)\n* Prof Daniel Perry (University of Liverpool)\n* Ms Vivi Gregory-Osborne (Patient and Public Contributor) \n* Mrs Helen Gregory-Osborne (Patient and Public Contributor)",{"url":192,"alt":84,"width":85,"height":86},"spell-content-image-15.svg",{"sectionLabel":194},"Co-Applicants",{"type":91,"settings":196,"title":197,"text":198,"image":199,"sectionSettings":201},{"imgWidth":93,"imgPosition":88},"## Current research management team","* Loretta Davies\n* Heidi Fletcher\n* Miriam Tillmann-Morris\n* Akiko Greshon",{"url":200,"alt":84,"width":85,"height":86},"spell-content-image-10.svg",{"sectionLabel":202},"current research management team","\u002Fpages\u002Fabout.en",{"title":28},"pages\u002Fabout.en","XkW14KK1u4p4pzHzspsev3vjLcFmqFtMZskbQZHh2vM",{"id":208,"extension":5,"meta":209,"stem":284,"__hash__":285},"dataFiles\u002Fdata\u002Frecruitment.json",{"recruitmentCharts":210},[211],{"chartTitle":212,"recruitmentTarget":213,"chartData":214},"Current recruitment for The SPELL Study","334 participants identified through the Cerebral Palsy Integrated Pathway, recruited from at least 12 UK NHS Trusts",{"datasets":215,"labels":251},[216],{"fill":30,"backgroundColor":217,"borderColor":217,"title":218,"label":219,"data":220},"#3f56a7","Actual","Actual recruitment",[221,221,150,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250],"2","8","13","15","21","39","48","59","68","74","83","92","101","108","115","127","139","146","157","171","181","193","206","213","221","233","235","240","247","256",[252,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283],"Nov-23","Dec-23","Jan-24","Feb-24","Mar-24","Apr-24","May-24","Jun-24","Jul-24","Aug-24","Sep-24","Oct-24","Nov-24","Dec-24","Jan-25","Feb-25","Mar-25","Apr-25","May-25","Jun-25","Jul-25","Aug-25","Sep-25","Oct-25","Nov-25","Dec-25","Jan-26","Feb-26","Mar-26","Apr-26","May-26","Jun-26","data\u002Frecruitment","qRf8-osCpDrc4oM45HOUD89TdeAdeHSp6fvQL62csVs",1789141284174]