Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy
Condition: Cerebral Palsy; Motor Dysfunction; Acupuncture
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The investigators design a Multi-center randomized, control study to evaluate the therapeutic
      effect of the scalp acupuncture treatment for motor dysfunction in children with cerebral
      palsy by using the following outcomes: motor function, activity of daily living, quality of
      life.
    

Detailed description: 
      Cerebral palsy (CP) is a well-recognized neurodevelopmental condition beginning in early
      childhood and persisting throughout the lifetime. Motor disorders are often accompanied by
      disturbances of sensation, cognition, communication, perception, behavior, and seizures The
      activities of daily living and social participation are limited in children with CP due to
      motor dysfunction, this greatly influences the CP patient's quality of life, and return to
      society.

      Western conventional treatment of CP is multi-professional rehabilitation. In China, CP
      rehabilitation mainly develops the clinical mode of combining traditional Chinese medicine
      and western medicine. Acupuncture use as a complementary or alternative therapy has increased
      worldwide and has become widely applied to CP rehabilitation, which confirms that the
      efficacy of acupuncture can have a great impact on CP management. Many studies have shown
      that scalp acupuncture has a remarkable treatment efficacy on motor dysfunction in children
      with CP in China. But, Although acupuncture as a treatment for cp has become widely accepted
      and showed better clinical curative effect than conventional treatments, a Meta-Analysis
      published in 2018 based on clinical randomized controlled trials summarized that the clinical
      curative effect of acupuncture treatment in children with CP remains uncertain due to the
      small number of randomized controlled trials available and the small sample sizes. More
      high-quality and large-scale studies are still needed. The purpose of this study is to
      observe the therapeutic effect of scalp acupuncture treatment for motor dysfunction in
      children with CP by using the international general evaluation scales.

      In this 12-week, assessor-blind, randomized, controlled study of scalp acupuncture as
      additional treatment with the rehabilitation treatment, a total of 76 children with cerebral
      palsy will be recruited. The patients will be randomly assigned to two different groups: 1)
      the treatment group and 2) the control group. The treatment group (n=38) will receive scalp
      acupuncture combined with rehabilitation treatment for 3 times per week for 12 weeks, and the
      control group (n=38) will receive rehabilitation treatment for 3 times per week for 12 weeks.
      Both groups will be evaluated at baseline, week4 (treatment 12), week 8 (treatment 24),
      week12(treatment 36) and week 24(follow-up) using GMFM scale, FMFM scale, PEDI scale and
      CP-QOL scale. The study will be conducted at Children's Hospital of Fudan University.
    

Intervention name(s): scalp acupuncture treatment; Rehabilitation Treatment
Intervention type(s): Other; Other
Intervention description(s): The parameters for scalp acupuncture are set as follows:
Scalp acupoint selection: The Motor Area of Jiao's Scalp acupuncture and Si shencong (EX-HN1).
Acupuncture manipulation: Disposable stainless steel needles will be manually inserted in at an approximately 15-degree angle to a depth of 1.5-2.0 cm respectively along the upper point and middle point of the motor area on the scalp. The acupuncture direction of Si shencong (EX-HN1) acupoint is toward the Baihui (GV20) acupoint. the needles will be rotated for at least 200 revolutions per minute for 1 minute every 20 minutes for a total of 60 minutes.
Treatment course: three times a week, 12 weeks in total.; The children with CP will receive the conventional rehabilitation programs as mentioned above. The rehabilitation programs will be carried out three times a week (once every other day) for 12 weeks, and every time, the rehabilitation treatment (PT and OT) will last approximately for 1 hour. All rehabilitation treatments will be carried out by qualified therapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; Motor dysfunction; Scalp acupuncture treatment; Safety/Efficacy assessment