Action Observation Based Rehabilitation of Children With Unilateral Cerebral Palsy
Condition: Hemiplegic Cerebral Palsy; Motor Activity
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Recent evidence suggested that Action Observation Therapy (AOT), based on observation of
      actions followed by immediate reproduction, could be a useful rehabilitative strategy for
      promoting functional recovery of children affected by Unilateral Cerebral Palsy (UCP).

      The AOT is based on the discovery of mirror neurons, a class of visuomotor neurons that are
      activated when the individual performs a targeted action, both when observing the same action
      performed by another individual.

      An important assumption of AOT is that the mirror system, thanks to its visuomotor
      properties, is able to coordinate visual information with the observer's motor experience.
      Indeed, the actions outside the individual's behavioral repertoire are elaborated and
      categorized only on the basis of visual characteristics, without inducing any phenomenon of
      motor resonance in the observer's brain.

      Therefore, given the deficiency of their motor repertoire, children affected by UCP could
      have a reduced activation of the mirror system during the observation of actions performed by
      healthy subjects. Nevertheless, this activation could increase during the observation of the
      same actions performed by a subject with similar motor strategies, due to a similar form of
      hemiplegia.

      The present project is a randomized controlled clinical trial to verify the influence of the
      observed model on the effectiveness of AOT in the rehabilitation of the affected upper limb
      in children with UCP. In particular, the study will verify whether the rehabilitation through
      AOT based on a pathological model (improving the patient's current abilities) gives more
      results than AOT based on a typical (healthy) development model, as reported by all the
      documented researches in literature.

      Furthermore, to investigate the functional reorganization of the sensorimotor system after
      rehabilitative treatment, a subgroup of participants will be subjected to a fMRI session
      (Functional Magnetic Resonance), to verify functional changes, comparing data before and
      after AOT.
    

Detailed description: 
      The study will compare two rehabilitation models through AOT to assess feasibility and
      effectiveness. In the preliminary phase of the study a single rehabilitation treatment
      protocol will be planned, based on the observation and execution of unimanual and bimanual
      actions integrated in activities that are significant for the subject's age group. The
      recorded actions will be performed by a child with typical development and by two hemiplegic
      children:

        1. upper limb disability with grades between 4-5 according to House Functional
           Classification (HFC) system (corresponding to synergic hand of Ferrari and Cioni's
           Kinematic Hand Classification).

        2. upper limb disability with grades between 6-7 according to HFC system (corresponding to
           subfunctional hand of Ferrari and Cioni's Kinematic Hand Classification).

      The participants (N. 26) randomly assigned to the experimental group will be subjected to the
      rehabilitation protocol through AOT based on the observation of the "Pathological Model". The
      model, while showing a manipulation strategy similar to that of the study participant, will
      show an improvement with respect to the patient's current abilities. The children randomly
      assigned to the control group will be subjected to the rehabilitation treatment protocol
      through AOT based on the "Typical developmental model".

      Both experimental and control treatment will consist of a minimum of 10 hours (min. 10, max
      15) for a period of 15 consecutive working days (3 weeks). Each video sequence will show a
      specific action repeated several times for 3 minutes. Subsequently, participants will be
      asked to perform the action observed with their hemiplegic upper limb or with both upper
      limbs for a maximum of 3 repetitions.

      A subgroup of study participants (N. 8+8) from both groups will undergo two fMRI sessions,
      before and immediately after the AOT.

      The fMRI session consists of two experimental tasks:

        1. action observation (functional session 1-2), in which patients will observe short videos
           in which actions are performed with the right hand from a subjective perspective.

        2. motor task (session 3), in which actions consist in reaching-grasping an object (a cube,
           a sphere or a cylinder) and putting it into boxes, placed on the right and on the left
           of the object.

      The study consists of two experimental conditions:

        1. Observation of the paretic hand, in which the actions will be performed by another
           patient with UCP.

        2. Observation of the healthy hand, in which the action will be reproduced by a healthy
           model.

      The aim of the study is to investigate the functional reorganization of sensorimotor system
      comparing functional activation before and after rehabilitation with AOT.
    

Intervention name(s): AOT Pathological Model Experimental Group; AOT Healthy Model Control Group
Intervention type(s): Other; Other
Intervention description(s): The children will participate in a rehabilitation intervention based on the observation of unimanual and bimanual actions performed by a model with the same degree of motor impairment, but an improvement on the participant's current abilities.; The children assigned to the healthy group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model
Other intervention name(s): Pathological Model; Healthy Model
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled experimental study, with 1:1 allocation ratio and two-armed blind assessment. Randomization will be stratified by age and level of HFC system to obtain two groups balanced with respect to the level of functional impairment of the upper limbs to be subjected to treatment in the two groups. Clinical evaluations will be performed before treatment (T0), at the end of treatment (T1), from 8 to 12 weeks after the end of treatment (T2) and finally, from 24 to 28 weeks after the end of treatment (T3).
Evaluation by fMRI will be performed at T0 and T1.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemiplegic Cerebral Palsy; Mirror neuron System; Action Observation; Rehabilitation; fMRI