Clinical trial NCT03921281: Evaluating the Therapeutic Effect of Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy
Official title: Scalp Acupuncture Treatment for Motor Dysfunction in Children With Cerebral Palsy: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Motor Dysfunction
Acupuncture
Keywords: Cerebral palsy
Motor dysfunction
Scalp acupuncture treatment
Safety/Efficacy assessment
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. cerebral palsy patients between 12 and 72 months old
2. cerebral palsy was diagnosed according to the criteria of CP in international guidelines
3. children with CP of the spastic type
4. voluntary participation and informed consent signed

Exclusion Criteria:

1. visual, auditory and mental disorders, affecting the rehabilitation assessment
2. the child with epilepsy who is not under control with medication
3. bleeding tendencies
4. being oversensitive to acupuncture
5. use of muscle relaxants or herbal therapies during the study period
6. participation in another clinical trial

Primary outcomes:
measure: Change from Baseline GMFM at 4 weeks, 8 weeks and 12 weeks
timeFrame: The GMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
measure: Change from Baseline FMFM at 4 weeks, 8 weeks and 12 weeks
timeFrame: The FMFM will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Secondary outcomes:
measure: Change from Baseline PEDI at 4 weeks, 8 weeks and 12 weeks
timeFrame: PEDI will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
measure: Change from Baseline CPQOL at 4 weeks, 8 weeks and 12 weeks
timeFrame: CPQOL will be assessed at baseline, interventions period (4 weeks, 8 weeks and 12 weeks) and fellow-up period at (24 weeks).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Jun Wang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, Shi W, Khiati D, Shi B, Shi X, Luo D, Wang Y, Deng R, Huang H, Li J, Yan W, Yang H. Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial. Trials. 2020 Jan 6;21(1):29. doi: 10.1186/s13063-019-3986-z.