Functional Electrical Stimulation During Walking in Cerebral Palsy
Condition: Cerebral Palsy; Spastic; Foot Drop
MeSH terms: Muscle Spasticity; Cerebral Palsy; Peroneal Neuropathies
Study type: Interventional

Summary: 
      Children with spastic cerebral palsy (CP) often walk with insufficient ankle dorsiflexion in
      the swing phase. A pathological gait, known as drop-foot gait, can be the result and this has
      2 major complications: foot-slap during loading response and toe-drag during swing. This is
      partly caused by weakness of the anterior tibial muscle and partly due to co-contraction of
      both the fibular- and anterior tibial muscle. For classification of gait, the Winters scale
      can be used, where unilateral CP with dropfoot is classified as type I.

      In daily life these problems cause limited walking distance and frequent falls, leading to
      restrictions in participating in daily life. The current guideline for spastic cerebral palsy
      describes the following therapies: 1) conservative therapy (physiotherapy, orthopaedic shoes
      and orthoses) 2) drugs suppressing spasticity 3) surgical interventions.

      Functional electrical stimulation (FES) may be an effective alternative treatment for
      children with spastic CP and a drop foot. By stimulating the fibular nerve or the anterior
      tibial muscle directly during the swing phase, dorsiflexion of the foot is stimulated. In
      contrast to bracing, FES does not restrict motion, but does produce muscle contraction, and
      thus has the potential to increase strength and motor control through repetitive neural
      stimulation over time.

      In a systematic review the investigators found that FES immediately improves ankle dorsal
      flexion and reduces falls and these effects also sustain. However, it should be noted that
      the level of evidence is limited. Until now, the use of FES in CP is limited and no data
      exist about the effects on walking distance (activity level) and participation level.

      The overall objective of this study is to conduct a randomised cross-over intervention trial
      in children with unilateral spastic CP with 12 weeks of FES (for every participant) and 18
      weeks of conventional therapy. The effectiveness of FES will be examined at participation
      leven, using individual goal attainment. Next to that the effect at gait will be measured. An
      additional goal is to investigate the cost effectiveness of FES, which, in case of a positive
      effect, may support allowance by insurance companies.
    

Detailed description: 
      Children with spastic cerebral palsy often walk with insufficient ankle dorsiflexion in the
      swing phase or with eversion of the foot. A pathological gait, known as drop-foot gait, can
      be the result and this has 2 major complications: foot-slap during loading response and
      toe-drag during swing. This is partly caused by weakness of the anterior tibial muscle and
      partly due to co-contraction of both the fibular- and anterior tibial muscle. In time, the
      disorder appears to be progressive due to atrophy and contractures of the muscle and
      increasing bodyweight. For classification of gait, the Winters scale can be used, where
      unilateral CP with dropfoot is classified as type I.

      In daily life these problems cause limited walking distance and frequent falls. This can lead
      to restrictions in participating in daily activities at school and in leisure. The current
      guideline for spastic cerebral palsy describes the following therapies: 1) conservative
      therapy, which includes physiotherapy, orthopaedic shoes and orthoses. 2) systemically and
      locally applied drugs suppressing spasticity. 3) surgical interventions, e.g. tenotomy,
      transposition and osteotomy. In each intervention, there is the risk of side effects, such as
      sedation with oral medications, pressure sores and atrophy in a static orthosis, temporary
      effect in a Botulinum toxin A treatment and surgical complications due to a result of the
      surgery, and on the other hand as a result of the execution.

      Functional electrical stimulation (FES) may be an effective alternative treatment for
      children with spastic CP and a drop foot. By stimulating the fibular nerve or the anterior
      tibial muscle directly during the swing phase, dorsiflexion of the foot is stimulated. In
      contrast to bracing, FES does not restrict motion, but does produce muscle contraction, and
      thus has the potential to increase strength and motor control through repetitive neural
      stimulation over time.

      In a systematic review the investigators found that FES immediately improves ankle dorsal
      flexion and falls. In addition, longer sustained effects of FES on ankle dorsal flexion and
      falls are found. However, it should be noted only two study studies (4 articles) were of
      level II class evidence (small RCT) and all other studies used a single subject design. Until
      now, the use of FES in CP is limited and no data exist about the effects on walking distance
      (activity level) and participation level.

      The overall objective of this study is to conduct a randomised cross-over intervention trial
      in children with unilateral spastic CP with 12 weeks of FES for every participant and 18
      weeks of conventional therapy. The effectiveness of FES will be examined at participation
      leven, using individual goal attainment. With every individual a goal at walking distance
      will be set, next to possible other goals. Next to that, results will be measured at the
      activity and functional level: the effect at gait kinematics (such as ankle dorsiflexion and
      balance), walking distance, falls, spasticity and muscle force. The type of brain damage of
      the patients is also taken in to account. An addition al goal is to investigate the cost
      effectiveness of FES, which, in case of a positive effect, may support allowance by insurance
      companies.
    

Intervention name(s): FES
Intervention type(s): Device
Intervention description(s): Functional electrical stimulation of the ankle dorsiflexors during walking, using a (superficial) neurostimulator with tilt sensor.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomisation for the order of treatments and thereby for the total length of the 'conventional therapy phase'.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment