The Effects of Electrical Stimulation Gait Training on Walking and Posture for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This proposal is designed to achieve the following specific aims and will test the associated
      hypotheses:

      AIM 1: To compare walking ability, standing posture, gait initiation and functional standing
      and stepping of twenty children with typical development to that of twenty children with
      spastic diplegia or hemiplegia, CP.

      Hypotheses

        -  Children with CP will demonstrate impaired coordination as compared to children of
           typical development. In addition, children with CP will demonstrate inappropriate foot
           contact area, decreased velocity and step length as compared to children of typical
           development.

        -  Children with CP will demonstrate impaired postural control as compared to children of
           typical development.

        -  Children with CP will demonstrate an impaired gait initiation motor program as compared
           to children with typical development.

        -  Children with CP will take more time to complete the timed up and go test and
           demonstrate decreased reaching distances in the functional reach test as compared to
           children of typical development.

      AIM 2: Using a single-blinded, randomized, controlled study design, to assess the ability of
      a 12-week at-home electrical stimulation gait training program to improve walking ability,
      standing posture, gait initiation, functional standing and stepping, and satisfaction with
      walking ability for a group of 10 children with spastic diplegia or hemiplegia CP as compared
      to a group of 10 children with spastic diplegia or hemiplegia CP who undergo a 12-week
      at-home gait training program without electrical stimulation.

      Hypotheses

        -  The ES gait training group will demonstrate improved joint coordination as compared to
           the group undergoing a gait training program without ES. The ES gait training group will
           demonstrate improved foot contact area, increased self-selected walking velocity and
           greater step length as compared to the group undergoing a gait training program without
           ES.

        -  The ES gait training group will demonstrate improved postural control as compared to the
           group undergoing a gait training program without ES.

        -  The ES gait training group will demonstrate improved gait initiation as compared to the
           gait training group without ES.

        -  The ES gait training group will demonstrate decreased times on the Timed Up and Go and
           an increase in functional reach as compared to the group undergoing a gait training
           program without ES.

        -  The ES gait training group will demonstrate greater satisfaction and self-perceived
           performance on everyday tasks related to walking function and posture as measured by the
           COPM compared to the group that undergoes a gait training program without ES.
    

Detailed description: 
      This is a single blinded, randomized, controlled pre-test/post-test study design (Figure 4).
      The twenty children with spastic diplegia or hemiplegia CP will be randomized by a
      statistician to one of two treatment groups. One group will undergo a 12-week at-home gait
      training program with ES, subjects/guardians can choose either the surface or percutaneous
      stimulation subgroup, and the second group will undergo a 12-week at-home gait training
      program without ES. For both groups, data will be collected at five points: just before gait
      training, after 4 and 8 weeks of gait training, at the conclusion of gait training (after 12
      weeks), and 4 weeks after gait training has been discontinued (16 weeks post initiation of
      gait training). Data collection at each follow-up point will include the kinetics and
      kinematics of walking, standing posture, gait initiation, plantar pressures, the
      administration of the Timed Up & Go and Functional Reach Test, and the assessment of lower
      extremity muscle strength using a hand-held dynamometer. The Canadian Occupational
      Performance Measure (COPM) will be applied before and after the 12-week gait training program
      and 4 weeks after the gait training has been discontinued. For the 20 children with typical
      development, the same data will be collected (except for the COPM) and used for comparison to
      the pre-training data collected from all 20 children with CP.
    

Intervention name(s): Walking Practice with Functional Electrical Stimulation; Walking Practice
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Functional Electrical Stimulation; FES; Walking; Practice; Coordination; Posture