Cerebral Palsy: Ankle Foot Orthoses - Footwear Combinations
Condition: Cerebral Palsy (CP)
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Ambulatory children with cerebral palsy (CP) demonstrate altered lower limb biomechanical
      alignment in walking (e.g. excessive hip/knee flexion or equinus during stance) and
      experience walking activity limitations that negatively influence their ability to
      participate in day to day life. Ankle Foot Orthoses (AFO) are a fundamental rehabilitation
      strategy to facilitate walking in children with CP; yet, a review suggests that efficacy of
      the "traditional" solid AFO (TSAFO) in this population remains equivocal. A novel decision
      tree to guide orthotic prescription proposes a patient-specific method for adjusting AFO
      alignment and integrating footwear modifications (Ankle Foot Orthoses-Footwear Combinations,
      AFO-FC). This approach is based on visualizing the sagittal plane orientation of the ground
      reaction force vector with respect to lower limb segments during gait. The AFO-FC represents
      a paradigm shift in orthotic management as it accommodates ankle equinus contractures in a
      rigid AFO, reorients the tibial segment with a heel wedge under the AFO, and applies
      different heel, midsole and forefoot shoe modifications to restore lost ankle-foot rockers.
      The primary goal of AFO-FCs are to improve stability by facilitating more normal segment
      kinematics in single limb stance, decreasing hip/knee flexion. Despite their promise,
      evidence of an immediate positive effect on midstance alignment is limited, with no evidence
      of clinical effectiveness.

      This proposal assesses the feasibility of using a randomized waitlist study to acquire pilot
      data on a targeted clinical cohort of children with CP evaluating the effectiveness of
      AFO-FCs as compared to TSAFO during daily life. Individual joint and combined kinematics and
      kinetics will be examined for potential mechanisms of action as well as daily walking
      performance, balance and satisfaction with the AFO-FC in 30 ambulatory children with CP, ages
      4-9 years, with bilateral crouch or equinus gait pattern, comparing gait in TSAFO to the
      AFO-FCs.
    

Detailed description: 
      The goal of this proposal is to assess the feasibility of using a randomized waitlist study
      to acquire pilot data on a targeted clinical cohort of children with CP evaluating the
      effectiveness of AFO-FCs as compared to TSAFO during daily life. Individual joint and
      combined kinematics and kinetics will be examined for potential mechanisms of action as well
      as daily walking performance, balance and satisfaction with the AFO-FC in 30 ambulatory
      children with spastic diplegia CP, ages 4-9 years, with bilateral crouch or equinus gait
      pattern, comparing gait in TSAFO to the AFO-FCs.

      Aim 1: Examine the effect of AFO-FC on individual joint kinematics, overall gait deviations
      and walking speed as compared to the TSAFO in children with CP. Multiple gait deviations
      (e.g. crouch or equinus) in CP result in slow, inefficient walking [14]. We hypothesize that
      the individualized ankle angle, leg segment alignment, and footwear profiles of the AFO-FCs
      will optimize lower limb joint kinematics, decrease overall gait deviations facilitating
      longer step lengths (improved stance stability), with resultant increased gait speed as
      compared to TSAFO. Instrumented gait analysis will assess gait speed and calculate changes in
      joint specific kinematics with the Gait Profile Score (GPS) and overall combined gait
      kinematics with the GDI.

      Aim 2: Examine the effect of AFO-FC on daily walking activity, balance, mobility, and
      satisfaction as compared to the TSAFO in children with CP. We hypothesize that the AFO-FC
      will positively affect community walking activity levels, balance, physical activity and
      satisfaction as compared to the TSAFO. Walking activity will be captured by the StepWatch ®
      accelerometer; balance by the Pediatric Balance Scale; physical activity by the Patient
      Reported Outcomes Measurement System (PROMIS®) Pediatric Physical Activity and the Gait
      Outcomes Assessment List (GOAL); and satisfaction with device by the Orthotic and Prosthetic
      Users' Survey (OPUS).
    

Intervention name(s): Ankle Foot Orthoses-Footwear Combination; Traditional Solid Ankle AFO (TSAFO)
Intervention type(s): Other; Other
Intervention description(s): This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.; This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study Design and Randomization. A randomized waitlist trial will be used to compare the AFO-FC to TSAFO in ambulatory children with CP.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment