Progressive Supervised Home-based Strength Training in Children With Spastic Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      A randomized controlled trail will be carried out to investigate the effect of a 12-week
      supervised home-based progressive strength intervention in children with spastic cerebral
      palsy aged 5-11 years. The results of this strength intervention aiming for increased
      strength and muscle hypertrophy will serve as input for a clinical decision making framework
      based on muscle and tendon architecture.
    

Detailed description: 
      Background: The alterations of morphological muscle and tendon properties are a primary
      determinant of the pathological muscle behaviour in spastic cerebral palsy (SCP). As
      treatments aim to reduce the progressive secondary problems, they are mainly directed at the
      muscle level. Muscle morphology features like volume, fascicle architecture and tendon
      properties are all responsive to treatment, but these treatment responses seem to be both
      patient and muscle-specific. Therefore, objective tools and protocols are needed for the
      evaluation of morphological muscle and tendon (MMT) properties in routine clinical practice.
      These are required to guide the patient-specific selection of appropriate, rationalized
      treatment choices and to determine the impact of these treatments on the MMT properties, the
      muscular impairment and function in children with SCP.

      This intervention study is one out of three intervention studies focused on defining the
      effects of conservative treatments (strengthening, stretching and botulinum toxin injections)
      on muscle and tendon architecture. In this phase of the Treatment Algorithms based on Muscle
      and Tendon Morphology (TAMTA) project, we aim to develop specific guidelines for these
      treatment options linked to the MMT evaluation protocol. To achieve this goal, prediction
      models based on baseline MMT parameters for the prognosis of specific treatment outcomes will
      be developed from the data of the three intervention studies.

      Aim: (1) determine whether the 12-week program of targeted progressive strengthening of the
      plantar flexors, the knee flexors and extensors leads to changes in the MMT properties of
      medial gastrocnemius, semitendinosus and rectus femoris, in the muscle strength and in gross
      motor function; and (2) determine the correlation between baseline MMT properties and the
      changes in the outcome parameters.

      Methods/Design: A randomized controlled trial will be conducted in 40 ambulatory children
      with a confirmed diagnosis of SCP between 5 and 11 years of age. Participants will be
      randomized to the intervention group (who will additionally receive the strengthening program
      while continuing their usual care) or to the waitlist-control group (who will continue their
      usual care without additional treatment) using the randomization by minimization method (with
      influencing characteristics age and GMFCS level). Participants in the control group will be
      able to participate in the intervention after the control period. The MMT parameters of the
      medial gastrocnemius, tibialis anterior, semitendinosus and rectus femoris and the isometric
      and functional strength for the 4 related lower limb muscle groups (plantar flexors,
      dorsiflexors, knee flexors and knee extensors) as well as the gross motor function will be
      assessed before and after the 12-week program. After 6 weeks a short evaluation of the MMT
      parameters, isometric and functional strength will take place.

      The change in primary outcome parameters before and after training of the intervention group
      will be compared to the data behaviour of the control group. Secondly, to explore the
      predictive value of specific baseline MMT parameters on treatment effect, both univariate and
      multivariate linear regression analyses will be conducted to identify significant predictive
      variables for the primary outcome parameters.
    

Intervention name(s): Progressive strength training
Intervention type(s): Behavioral
Intervention description(s): Progressive Supervised Home-based Strength Training
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized controlled trial with waitlist control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Spastic Cerebral Palsy; Progressive Strength Training; Muscle morphology