title: The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol.
abstract: BACKGROUND
  Children with cerebral palsy (CP) often have an altered gait. Orthopaedic surgery, spasticity management, physical therapy and orthotics are used to improve the gait. Interventions are individually tailored and are planned on the basis of clinical examinations and standardised measurements to assess walking ('care as usual'). However, these measurements do not describe features in the gait that reflect underlying neuro-musculoskeletal impairments. This can be done with 3-dimensional instrumented gait analysis (IGA). The aim of this study is to test the hypothesis that improvements in gait following individually tailored interventions when IGA is used are superior to those following 'care as usual'.
  
  
  METHODS
  A prospective, single blind, randomised, parallel group study will be conducted. Children aged 5 to 8 years with spastic CP, classified at Gross Motor Function Classification System levels I or II, will be included. The interventions under investigation are: 1) individually tailored interdisciplinary interventions based on the use of IGA, and 2) 'care as usual'. The primary outcome is gait measured by the Gait Deviation Index. Secondary outcome measures are: walking performance (1-min walk test) and patient-reported outcomes of functional mobility (Pediatric Evaluation of Disability Inventory), health-related quality of life (The Pediatric Quality of Life Inventory Cerebral Palsy Module) and overall health, pain and participation (The Pediatric Outcome Data Collection Instrument). The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks; however, exclusively for the patient-reported outcomes.
  
  
  CONCLUSIONS
  To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention based on the use of IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02160457 . Registered June 2, 2014.
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. helrasmussen@health.sdu.dk.|Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. helrasmussen@health.sdu.dk.
authors.forename: Helle Mätzke
authors.initials: HM
authors.lastname: Rasmussen
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. niels.w.pedersen@rsyd.dk.|Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. niels.w.pedersen@rsyd.dk.
authors.forename: Niels Wisbech
authors.initials: NW
authors.lastname: Pedersen
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. soeren.overgaard@rsyd.dk.|Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. soeren.overgaard@rsyd.dk.
authors.forename: Søren
authors.initials: S
authors.lastname: Overgaard
authors.affiliation: H.C. Andersen Children's Hospital, Odense University Hospital, ᅟOdense, Denmark. lars.kjaersgaard.hansen@rsyd.dk.
authors.forename: Lars Kjaersgaard
authors.initials: LK
authors.lastname: Hansen
authors.affiliation: Department of Paediatrics, Lillebaelt Hospital, Kolding, Denmark. ulrike.dunkhase-heinl@rsyd.dk.|Department of Paediatrics, Hospital of Southern Jutland, ᅟAabenraa, Denmark. ulrike.dunkhase-heinl@rsyd.dk.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Dunkhase-Heinl
authors.affiliation: Department of Paediatrics, Hospital of Western Jutland, ᅟEsbjerg, Denmark. yanko.petkov@rsyd.dk.
authors.forename: Yanko
authors.initials: Y
authors.lastname: Petkov
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. vilhelm.engell@rsyd.dk.|Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. vilhelm.engell@rsyd.dk.
authors.forename: Vilhelm
authors.initials: V
authors.lastname: Engell
authors.affiliation: University of Salford, Manchester, United Kingdom. r.j.baker@salford.ac.uk.
authors.forename: Richard
authors.initials: R
authors.lastname: Baker
authors.affiliation: Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark. ahlarsen@health.sdu.dk.|Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. ahlarsen@health.sdu.dk.
authors.forename: Anders
authors.initials: A
authors.lastname: Holsgaard-Larsen
mesh_terms: D002547:Cerebral Palsy / Q000175:diagnosis / Q000503:physiopathology / Q000534:rehabilitation*; D002648:Child; D002675:Child, Preschool; D004185:Disability Evaluation; D006233:Persons with Disabilities / Q000534:rehabilitation*; D005260:Female; D005500:Follow-Up Studies; D005684:Gait / Q000502:physiology*; D006801:Humans; D008297:Male; D009048:Motor Skills / Q000502:physiology*; D026741:Physical Therapy Modalities / Q000295:instrumentation*; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D016138:Walking / Q000502:physiology*