Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      A randomized, controlled, and evaluator-blinded trail will be carried out comparing CIMT with
      or without AOT on sensorimotor outcome in children with unilateral CP aged 5 to 12 years.
      Additionally the potential role of neurological factors, including the anatomical
      characterization of the brain lesion, structural/functional connectivity and cortical
      reorganization, on treatment response will be investigated.
    

Detailed description: 
      Background: Problems in upper limb (UL) function in children with unilateral cerebral palsy
      (UCP) are traditionally trained with motor execution treatment models, such as Constraint
      Induced Movement Therapy (CIMT). However new approaches based on a neurophysiological model
      such as action observation training (AOT) may provide new opportunities for enhanced motor
      learning.

      Aim: The aim of study is to investigate the effects of an intensive treatment model
      consisting of CIMT and AOT compared to CIMT alone on UL function in children with UCP.
      Additionally the potential role of neurological factors (including the anatomical
      characterization of the brain lesion, structural/functional connectivity and cortical
      reorganization) on treatment response will be analysed.

      Methods/Design: A randomized, controlled, evaluator-blinded trial (RCT) will be conducted in
      40 children between 5 and 12 years of age. Before randomization, children are stratified
      according to their House Functional Classification Scale, age and type of cortical
      reorganization. The Intervention is accomplished during a 2-week day camp in which the
      children receive intensive therapy for six hours a day on 9 out of 11 consecutive days (54 h)
      including AOT or placebo observation training (POT) (15h). During the AOT the children in the
      experimental group watch video sequences showing goal-directed actions and subsequently
      execute the observed actions with the affected UL. Children in the POT group perform the same
      actions after watching computer games without biological movements.

      Outcome assessments include qualitative and quantitative measures of UL sensorimotor function
      across the International Classification of Functioning, Disability and Health (ICF). The
      primary outcome measure is the Assisting Hand Assessment (AHA). The medical imaging protocol
      includes structural Magnetic Resonance Imaging (MRI), Diffusion Kurtosis Imaging (DKI),
      resting state functional MRI (rs-fMRI) and Transcranial magnetic stimulation (TMS). The
      timeline for the assessment is T0 (1-1.5 month before the camp onset), T1 (before the
      intervention), T2 (after the intervention) and T3 (6 months after the intervention). Linear
      mixed models will be used to study time effects of the interventions and the interaction with
      neurological variables as covariates.
    

Intervention name(s): Constraint-induced movement therapy; Action observation training; Placebo observation training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): In a 2-week day camp model children receive constraint- induced movement therapy for six hours a day, for 9 out of 11 consecutive days. All children wear a tailor made hand splint on the unaffected upper limb for 6 hours per day while performing unimanual exercises individually or in a group based on shaping and repetitive practice.; Action observation training consists of 15 sessions of 1 hour. Children watch 3 minute video clips of unimanual goal-directed actions followed by 3 minutes of execution of the actions.; Placebo observation training consists of 15 sessions of 1 hour. Children perform the same actions as the AOT training after watching computer games without biological movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: unilateral cerebral palsy; upper limb rehabilitation