Orthotics in Ambulatory Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This project will examine the effect of solid ankle foot orthoses (SAFO) on day to day
      walking activity and life participation of ambulatory children with cerebral palsy. The
      investigators propose that SAFO have not effect on levels of walking and life participation
      versus not wearing the SAFO.
    

Detailed description: 
      This is a repeated measures trial with randomization of intervention in a cross over design
      which will quantify daily walking and physical activity levels for children with cerebral
      palsy (CP) with and without use of a solid ankle foot orthotic (SAFO). Current orthotic
      management guidelines are based primarily on evidence that SAFO use positively impacts body
      function and structure in clinic and lab based observations of activity and movement. Prior
      research has determined that wearing a SAFO improves different aspects of gait and mobility
      (stride and step length, single limb stance, velocity) for children with CP. However, these
      studies have been limited by small sample sizes, lack of comparison groups, inconsistency of
      orthotic fabrication, lack of clear and simple outcome measures and/or randomized control
      designs. No prior studies have evaluated the effect of SAFO use on activity performance
      outcomes.

      The purpose of this study is to determine the effect of wearing or not wearing current SAFO
      on a child's walking ability, participation in common life activities, and gait. Children
      ages 2 - < 10 years who have bilateral cerebral palsy, dynamic equinus gait deformity, and
      wear bilateral SAFOs fabricated by Cascade DAFO will be approached for participation.
      Enrolled children are randomly assigned to either wear or not wear their SAFOs for a 14 day
      intervention period. After this period is over, children will then do the opposite for a
      second 14 day intervention period. Children attend three study visits; at enrollment, after
      the first intervention period is over, and after the second intervention period. At the first
      visit, parents and children (where applicable) complete questionnaires regarding their
      participation in common life activities in the prior 7 days, and complete a walking
      evaluation. Children wear a StepWatch accelerometer during each intervention period, which
      counts the number of steps the child takes and the time each step was taken. After the second
      intervention period is complete, the child's participation in the research study is complete.
      One home visit is conducted at the end of each intervention period, where the questionnaires
      are repeated, and the StepWatch is downloaded and/or re - calibrated per protocol.
    

Intervention name(s): SAFO worn; SAFO not worn
Intervention type(s): Device; Other
Intervention description(s): Child wears their prescribed SAFO for 14 days by random assignment; Child does not wear their prescirbed SAFO for 14 days by random assignment
Other intervention name(s): Solid ankle foot orthoses (SAFO); Solid ankle foot orthoses (SAFO)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; orthotics; solid ankle foot orthoses