Gait Analysis and Interdisciplinary Interventions for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis, that improvements in gait pattern following
      individually tailored interventions guided by instrumented 3-dimensional gait analysis are
      superior to those used in 'care as usual'.
    

Detailed description: 
      Children with cerebral palsy (CP) who walk independently often have an altered gait pattern.
      Interdisciplinary interventions in terms of orthopaedic surgery, spasticity management,
      physical therapy and orthotics aim to improve the gait pattern. Standardised measurements are
      used in the Cerebral Palsy follow-Up Program to assess walking. However, these measurements
      do not describe features in the gait pattern reflecting underlying neuro-musculoskeletal
      impairments. This can be done with instrumented 3-dimensional gait analysis (IGA). It has
      never been investigated whether interdisciplinary interventions designed to address
      impairments identified by IGA result in improved gait pattern compared with 'care as usual'
      without IGA in children with CP. The aim of this study is to test the hypothesis, that
      improvements in gait pattern following individually tailored interventions guided by IGA are
      superior to those used in 'care as usual'.

      A prospective, single blind, randomised, parallel group study will be conducted. Participants
      will be recruited from the Cerebral Palsy follow-Up Program. Children aged 5 to 9 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 intervention addressing impairments identified by IGA and 2) 'care as
      usual' (interdisciplinary interventions without IGA). The primary outcome is gait pattern
      measured by the Gait Deviation Index. Secondary outcome measures are, walking performance and
      patient-reported outcomes of functional mobility, health-related quality of life and overall
      health, pain and participation. Explorative outcome measures include walking performance,
      gait pattern, behavior of health care providers and the applied interventions. 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 after start of intervention;
      however, exclusively for the patient-reported outcomes.

      To our knowledge, this is the first randomised controlled trial comparing the effects of an
      individually tailored interdisciplinary intervention designed to address impairments
      identified by IGA versus 'care as usual' in children with CP. Consequently, the study will
      provide novel evidence for the use of IGA in interdisciplinary interventions.
    

Intervention name(s): Intervention with IGA
Intervention type(s): Other
Intervention description(s): Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis
The instrumented gait analysis consists of four steps:
Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000)
Impairment-Focused Interpretation
Recommendation for interdisciplinary interventions
Dissemination of recommendations
The two modalities differs in the use of IGA, but the study is not indented to document the effect of IGA alone, but to document the difference in the effects of the interdisciplinary interventions, when IGA is implemented to the experimental group.
Other intervention name(s): Vicon T40 system, Vicon, Oxford, UK; Advanced Mechanical Technology Inc. (AMTI), OR6-7-1000, Watertown, USA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; Instrumented gait analysis; Gait Deviation Index