Cerebral Palsy Clinical Trial
Official title:
Instrumented Gait Analysis and Individually Tailored Interdisciplinary Interventions for Children With Cerebral Palsy: A Randomized Controlled Trial
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'.
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.
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