Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy

Cerebral palsy (CP) describes a group of disorders of the development of movement and posture that cause activity limitations; these disorders are attributed to non-progressive disturbances that occur in the developing foetal or infant brain [1]. Although the main feature of CP is a movement disorder, difficulties with cognition, learning, communication and behaviour often accompany CP. To manage these complicated situations, integrative therapies for rehabilitation have been developed and applied in practice [2]. From a systematic review of 49 studies, the pooled overall prevalence of CP was 2.11 per 1000 live births [3]. The prevalence of CP is 2.6 per 1000 children, and the attributable lifetime cost of CP is approximately 1.8 times higher than the basic lifetime medical cost of the general population in South Korea [4].

Intensive rehabilitation for young children is predicted to give potential benefits in terms of brain plasticity. Neuronal plasticity is enhanced in the developing brain, and it is usually adaptive and beneficial for neurological disorders such as CP. Clinical examples of adaptive neuronal plasticity include reorganization of cortical maps of the fingers in response to practice playing a stringed instrument and constraint-induced movement therapy to improve hemiparesis caused by CP [5].

In general, interventions include not only surgery or botulinum toxin for the inhibition of spasticity but also physical therapy (PT), occupational therapy (OT), speech therapy (ST), hydrotherapy, and other therapies [6]. Although there are public demands for complementary and alternative medicine (CAM) for children with CP, the lack of evidence makes alternative medicine difficult to implement in practice [7].

In a systematic review of traditional Chinese medicine (TCM) for children with CP, the authors concluded that a combination of either acupuncture plus chuna or acupuncture plus herbal medicine with conventional therapy showed significant beneficial effects on comprehensive function in terms of both physical and cognitive aspects, independence, and verbal function compared with conventional therapy alone [8]. Additionally, a rehabilitation approach including acupuncture that was intensely administered to young children with spastic CP resulted in significant functional improvement [9].

In Korea, children usually receive conventional treatment, including physical, occupational, or speech-language therapies, and they also have a demand for traditional Korean medicine (TKM) interventions such as acupuncture or herbal medicine. We now aim to investigate the effectiveness, safety, and cost-effectiveness of both conventional and TKM combination treatment for children with CP.