Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Cerebral palsy (CP) is a non-progressive disorder caused by an insult or injury to the brain
      when the brain is most rapidly developing and which results in some motor dysfunction. Causes
      for the injury to the brain are numerous and can occur prior to birth, during the birth
      process, or within the first few months following birth. The motor dysfunction can involve
      any or all four extremities but most often affects the legs, causing abnormal ambulation. The
      level of severity depends on the extent of the injury to the brain and can be mild to severe.
      In severe instances, the child is dependent on others for all his/her care.

      There is no known cure for CP, but physical and occupational therapies are administered in an
      attempt to improve function. The frequency of these therapies varies from once a week (the
      standard of care in the Western Hemisphere) to five times a week (the standard of care in
      Asia and some Eastern European countries). The current understanding of brain plasticity
      offers a theoretical explanation to justify the more intense approach. Active repetitive
      motor skill-directed rehabilitation utilizes the plasticity of the brain and can restore some
      function. Intense active physiotherapy can stimulate non-injured but 'dormant' neurons and
      prevent their 'natural' degeneration in order for them to substitute for the function of
      injured neurons. It is the very young brain that is most likely to respond to this therapy.

      The aim of this proposal is to evaluate the effect of administering both physical and
      occupational therapy five times each week for 12 weeks and compare it with the standard of
      care (SOC) approach of one time each week in children between the ages of 12 months and 36
      months. This is the first randomized crossover trial to both enroll this young a population
      of children with cerebral palsy as well as to evaluate this approach from both the therapists
      and the parents perspectives. The number of children that this study will enroll is larger
      than in most CP studies. The children will be evaluated clinically with two validated
      instruments, one of which was designed specifically for children with CP and is administered
      and scored by certified therapists and the other which was designed for children with
      developmental disabilities and is scored by the child's care provider. A sub-set of children
      will have a special type of MRI to evaluate any changes in the neurological structure of the
      brain.

      The Department of Pediatrics at the University of Arizona recently completed a collaborative
      study with the Neurologic Department at the Beijing Children's Hospital where the intense
      approach of five therapies per week is the SOC. The positive results prompted another
      investigation to determine if such an approach would be feasible in the United States. A
      compliance rate of 81% confirmed feasibility and the perception that parents who have a child
      diagnosed with CP will do whatever they can to improve their child's motor function.
    

Detailed description: 
      Specific Aim #1: To compare the effectiveness of an intense physiotherapy program with the
      current standard of care in the management of children with spastic cerebral palsy.

      Hypothesis #1: Children receiving a short cluster of intense therapies (5 times per week for
      12 weeks) will show greater functional gains as determined by the Gross Motor Function
      Measure (GMFM-66) and the Pediatric Evaluation Disability Inventory (PEDI) than those
      receiving the same therapies once a week, the current standard of care.

      Specific Aim #2: To determine if the functional gains by children with spastic cerebral palsy
      achieved with an intense physiotherapy program will continue to improve while receiving less
      intense standard weekly therapies for at least 36 weeks (9 months) following completion of
      the intense program.

      Hypothesis #2: Motor skills gained after 12 weeks of intensely administered physiotherapies
      as determined by the GMFM and the PEDI will continue to improve at a rate greater than that
      seen in children receiving the same therapies once a week, the current standard of care.

      Specific Aim #3: After receiving the same number of therapies at the end of the 48-week
      protocol, children receiving the intense series of therapies during the first 12-weeks will
      have made greater functional gains than those receiving them during the last 12-weeks.

      Hypothesis #3: Children who receive intense physiotherapies at an earlier age make greater
      gains then those who receive the same therapies at a later age.

      Specific Aim #4: To develop a clinical profile that will identify those children most likely
      to benefit from intensely administered physiotherapies.

      Hypothesis #4: Clinical and radiologic characteristics play a major role in response to
      therapy.

      Explorative Aim: To assess the correlation between clinical improvement from intense
      physiotherapies and anatomical changes using magnetic resonance imaging (MRI).

      Hypothesis: The improvements from intense physiotherapies seen in the clinical assessments
      will be reflected by alterations of brain connectivity parameters available from
      neuroanatomical MRI and diffusion tensor imaging (DTI).
    

Intervention name(s): Physical and occupational therapy
Intervention type(s): Other
Intervention description(s): The type of physiotherapy to be administered is Perception-Action (P-A). The P-A (motor) intervention is a child-driven approach without the need for special equipment and considers the child and environment as a single unit.Treatment is a coupling of the child with the environment. The environment is changed to enable, enhance or stimulate movement. The action is initiated by the child with the therapist augmenting the child's environment using touch (tactile information) or light support (cushions, bolsters, and gentle touch or pressure) to assist and/or alter the child's active movement. Toys are used and positioned in different places to encourage movement of upper and lower extremities and the trunk; reaching, turning, sitting balance, crawling, walking.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: intense therapy; brain plasticity; Perception-Action approach