Acupuncture combined with rehabilitation training improves pointed foot deformity and mental retardation in infants with spastic cerebral palsy: study protocol for a randomized controlled trial

Background: Pointed foot deformity and mental retardation are common clinical manifestations in children with spastic cerebral palsy. Comprehensive rehabilitation training is performed in cerebral palsy children with mental retardation, but its clinical effect is not satisfactory. Acupuncture at acupoints related to the motor, sensory, foot-motor-sensory, language and equilibrium areas can promote intelligence and effectively relieve local muscle tension. We propose that acupuncture combined with rehabilitation training mitigates pointed foot deformities in children with spastic cerebral palsy and contributes to the development of intelligence. This prospective, randomized, controlled clinical study will test the above hypothesis. Functional magnetic resonance imaging will be utilized to observe the changes in acupuncture-activated brain regions and to elucidate the mechanisms of acupuncture in treatment of spastic cerebral palsy. Methods/Design: This is a prospective, randomized, controlled clinical trial. Sixty children with spastic cerebral palsy, hospitalized in the Out-Patient Clinic of the Department of Pediatric Neurological Rehabilitation, the First Hospital fo Jilin University of China, will be recruited for trial participation. All subjects will be equally and randomly divided into a treatment group and control group. Patients in the treatment group will be subjected to conventional rehabilitation training after acupuncture. Patients in the control group will receive conventional rehabilitation training alone. The treatment will last for 6 months. Primary outcomes will be Gross Motor Function Measure, ankle range of motion, Gesell Developmental Scale and surface electromyography. Secondary outcomes will be: modified Ashworth Scale of muscle spasticity, Fine Motor Function Measure, Gross Motor Function Classification System, and functional magnetic resonance imaging. Discussion: It is hoped that the experimental results can provide quantitative data for acupuncture combined with rehabilitation training in the treatment of spastic cerebral palsy. Trial registration: Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-15007633) on December 24, 2015.