German Clinical Trials Register

Acronym/abbreviation of the study

VTCP

URL of the study

No Entry

Brief summary in lay language

The goal of this study is to quantify improvements on the speed of motor development in children with cerebral palsy, when a Vojta or Reflexlocomotion therapy program is implemented. Vojta Therapy is a physiotherapy technique widely used in the paediatric rehabilition. The hipothesis is that this therapy can increase the speed of gross motor function at early stages of this condition. Therefore, children at risk of neurological conditions under 18 month of age could participate in this study.

Brief summary in scientific language

Gross motor function and mobility have important roles for classification, assessment and research involving children with neuromotor disorders. Gross Motor Function Measure (GMFM) could be currently considered as gold standard for the quantification of gross motor function in the pediatric rehabilitation. These follow ups of thousands of children with cerebral palsy described the long term development of their gross motor function and defined five unalterable levels of severity. By the age of six, stability over time on the prognosticated level of mobility is expected. Even if GMFM was not designed to assess outcomes of therapeutic interventions, some author used its centiles to compare individual long term effects. On the other hand, uncompleted items of GMFM assessments are used as short term therapeutic goals and therefore, individually controlled comparison of the speed of acquisition of gross motor function seems to be possible within each range. Reflex Locomotion (RL) or Vojta Therapy has been reported clinically beneficial for strength, movement and motor activities in individual cases and is being considered within the second of three levels of evidence in interventions for cerebral palsy . Poor study design casted a shadow over the positive results in previous studies about Reflex Locomotion including lack of random sequence generation, concealed allocation, study blinding, incomplete outcome data collection and selective reporting. RL therapy was developed by Prof Vojta and uses locomotor patterns activated “reflexogenically”. Reflex Locomotion does not refer to the neuronal regulation, but is rather related to therapeutically applied external stimuli and their automatic movement responses. The afferent input of RL therapy generates important cortical and subcortical changes, especially in the ipsilateral putamen. The resulting outputs are differential responses that seem to be located in the brainstem and cerebellum, pontomedullary reticular formation and posterior cerebellar hemisphere and vermis. These automatic motor patterns aim to change task-related motor activation and its associated postural control , as well as to release and facilitate the development of the ontogenic postural function. RL Therapy has been reported clinically beneficial for strength, movement and motor activities in individual cases and is being considered within the second of three levels of evidence in interventions for cerebral palsy . Poor study design casted a shadow over the positive results in previous studies about RL including lack of random sequence generation, concealed allocation, study blinding, incomplete outcome data collection and selective reporting. The ethical limitations of randomized untreated control groups or placebo interventions limit the quality of the intervention in this field. Family participation in the decision making process is highly emphasized, and its integration on the therapeutic handling reduces economic cost and commuting times, and increases the dosing possibilities. The automatic motor patterns activated with Reflex Locomotion therapy aim to change task-related motor activation and its associated postural control , as well as to release and facilitate the development of the ontogenic postural function. Because functional training of compensatory strategies is not emphasized, gross motor improvements after Reflex Locomotion intervention seems to depend on the activation of the postural frame required for their acquisition, reducing compensatory strategies during the subsequent environment exposure. Our hypothesis is that there is an improvement on the postural function and therefore, on the speed of acquisition of gross motor function from the first weeks of application of Reflex Locomotion Therapy in children with neuromotor disorders. The purposes of this trial were to understand the effect of Reflex Locomotion therapy on the GMFM of children with cerebral palsy without specific training of its items, as well as to understand what role plays its dosage. METHODS Our clinical trial was designed to quantify changes in gross motor function after two months of Reflex Locomotion intervention. Children carried on clinically with the intervention but this short period would allow us to attribute changes to Reflex Locomotion, controlling better the influence of other factor (such as age maturation or other therapy inputs). This design will not allow us to understand long term effects, but the potentiality to facilitate motor and postural function development.