Evidence-based Physical Therapy in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The study aims to evaluate evidence-based practice behavior in usual care physical therapy in
      Flanders. Secondly, it aims to compare the effectiveness of a predefined physical therapy
      program based on evidence-based guidelines to the effects of a period of usual care. It is
      hypothesized that supporting therapists by providing a predefined evidence-based intervention
      program, will result in an improved treatment outcome compared to the usual care physical
      therapy.
    

Detailed description: 
      Participants A convenience sample of 16 children will be recruited at the Cerebral Reference
      Centre of the University Hospital Pellenberg. Children will be included when they are
      diagnosed with bilateral spastic CP, aged between 4 and 9 years and a Gross Motor Function
      level between I and III. Children are excluded when they received Botulinum Toxin A
      injections within the past six months, orthopedic surgery in the past or had severe
      associated problems that limited participation to therapy (blindness, deafness, severe
      cognitive limitations or autism).

      Design All children will start the study with a registration period. During this period, the
      children's usual physical therapy (UC) will be registered using a diary. Immediately
      following the UC period, children will be enrolled into a predefined intervention program
      (IP).

      Both the period of UC and IP will have a duration of 10 weeks. Before and after both periods,
      children will be evaluated using the Gross Motor Function Measurement (GMFM-88) and
      three-dimensional gait analysis (3DGA).

      Therapy interventions During the period of UC, no specific intervention will be provided.
      Children will receive the frequency, intensity and contents of therapy as they usually
      receive by their own private physical therapist. A diary will be provided to the child's
      physical therapist. The diary contains session forms, designed for the therapist to carefully
      register the contents of therapy after each session.

      In the session forms, the therapist will note down how much time of the therapy session will
      target problems at the different levels of the ICF. At the level of body structure and
      function, the time spent on muscle length and muscle strength will be registered. For muscle
      length, the therapists are asked to report the targeted muscles, the number of repetitions,
      the duration of stretch and treatment modality (activo, activopassivo or passivo). About
      muscle strength, therapists will note the specific muscle that was trained, the intensity
      (number of repetitions and resistance) and whether the exercise was performed as analytical
      (single-joint) or functional (multiple-joint) muscle work. Concerning activity level, the
      specific functional activity that was practiced and the averaged position in which this was
      performed, will be registered. Finally, the therapist will be asked to report whether any
      problems at participation level are specifically addressed.

      During the period of UC, the therapist will not be contacted and no instructions or advice
      will be provided regarding physical therapy treatment of the child.

      Intervention period

      Immediately following the UC period, children were enrolled into a predefined intervention
      program (IP), designed by the first and third author of the study. The programs will be
      executed by the child's personal physical therapist, who will agree to precisely follow the
      prescribed program. Similar as for the UC program, the children will receive the frequency of
      therapy as they usually receive by their own private physical therapist. Two different types
      of programs were designed. Ten children received an individually defined, targeted program
      tailored to the individual needs of the child and six children received a general program
      based on general age-appropriate treatment aims for children with bilateral spastic CP. For
      an extensive description of the differences and similarities between both types of
      intervention programs, the authors refer to our previous intervention studies. All
      intervention programs have two major common features. The first central and common aspect in
      the intervention programs was that basic principles regarding evidence-based training were
      respected. All programs consist of a predefined set of exercises to improve strength,
      selectivity and mobility and a set of functional exercises. Thereby, stretching is prescribed
      as three repetitions of 30 seconds and strength training was prescribed in series of three
      times 12 to 15 repetitions. Functional exercises are not restricted to a specific repetition
      number. As appropriate, all intervention programs will contain more than 50% of exercises at
      activity and participation level. The second major common feature in the intervention
      programs is the support and follow-up to the therapist. At the start of the intervention
      study, therapists will be visited and the prescribed program will be thoroughly explained.
      All exercises will be provided in a clear and structured way, with specific instructions
      regarding anatomical position, sets and repetitions. The specific exercises will be discussed
      and demonstrated if necessary. During the second or third week, the therapist will be
      contacted by phone or email to discuss the progress of the program and the possible needs to
      change and adjust exercises. Additionally, a follow-up visit will be organized around halfway
      through the program. During this visit, the program will again discussed and the therapist
      performed a regular therapy session using the program, in attendance of the first author of
      the study. Difficulties in performance were discussed and if necessary, some exercises were
      demonstrated. The opportunity for feedback on handling or position was thereby provided.

      Due to these common aspects in our programs, and because previous data analysis revealed that
      the overall effects of both programs were not found to be significantly different, we can
      test our hypothesis regarding the influence of evidence-based support on the pooled data-set.
    

Intervention name(s): No intervention, no follow-up, only registration; Intervention period
Intervention type(s): Other; Other
Intervention description(s): Usual Care; Predefined intervention program
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Physical Therapy; gait analysis; gross motor function