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STUDY PROTOCOL

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
Li-li Wang, Lin Du, Ling Shan, Han-yu Dong, Fei-yong Jia*

Department of Pediatric Neurological Rehabilitation, the First Hospital of Jilin University, Changchun, Jilin Province, China
*Correspondence to: Fei-yong Jia, M.D., erkekangfujia@163.com.
orcid: 0000-0002-8309-1395

Abstract
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 Mo-
tor 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.

Key words: acupuncture; spastic cerebral palsy; Ashworth Scale of muscle spasticity; surface electromyography; intelligence; ankle
range of motion; randomized controlled trial

doi: 10.4103/2468-5577.181237
How to cite this article: Wang LL, Du L, Shan L, Dong HY, Jia FY (2016) 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. Asia
Pac Clin Transl Nerv Syst Dis 1(2):69-75.

Introduction for 50–80% of cerebral palsy children. Pointed foot deformity

Cerebral palsy in children manifests mainly as motor dys- and mental retardation are common clinical manifestations
function, and is often associated with mental retardation, in these children (Rosenbaum et al., 2006).
vision and hearing loss, growth retardation, epilepsy and Children with pointed foot deformity exhibit pyramidal
abnormal behavior (Mukhopadhyay et al., 2015; Badia et al., tract damage and the stretch hyperreflexia is frequently
2016; Bartlett et al., 2016). Spastic cerebral palsy accounts the cause of muscle spasms. These spasms not only cause

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growth retardation and abnormal posture, but also induce a visual disorder appears after corticospinal tract injury
contracture, deformity and pain. The gastrocnemius and (Nanba et al., 2007), anisometropia, strabismus, low
soleus muscle spasm often results in ankle plantar flexion visual acuity, dynamic visual acuity of eye movement,
and dorsiflexion insufficiency. The heel cannot touch the graphic perception, and visual memory may change.
ground normally, producing pointed foot deformity and These impact the development of intelligence, especially
reducing the stability of the support surface of the affected attention, memory and spatial thinking. Preterm birth and
foot. This affects the standing and walking abilities of these low birth weight are risk factors for visual impairment in
children (Li et al., 2006). cerebral palsy children (Zhao et al., 2010). Our previous
The total prevalence of mental retardation was approxi- research has shown that comprehensive rehabilitation or
mately 70% in spastic cerebral palsy children (Hou et neurotrophic drug treatment for cerebral palsy has a cer-
al., 2004). A higher Gross Motor Function Classification tain promoting effect on the development of intelligence,
System score was associated with a higher proportion of but we did not study the improvement in pointed foot
mental retardation (Hou et al., 2004). Krägeloh-Mann deformity. Moreover, the therapeutic effects and safety
et al. (1995) considered that the incidence of periven- considerations are different between comprehensive
tricular leukomalacia was high in children with spastic rehabilitation and drug treatment. Our previous studies
diplegia, occurring in 87% of premature infants. When are listed in Table 1.

Table 1: Previous studies on cerebral palsy

Study Subject Type Intervention Outcome evaluation Conclusion
Wang 21 children Retrospective Collection of Abnormal brain MRI in 80.9% Ataxic cerebral palsy is induced
et al. with cerebral analysis medical history, child patients: cerebellar damage, by cerebellar damage: motor
(2008) palsy clinical signs, head obviously mental retardation, but retardation and balance
MRI, intelligent with the improvement of motor dysfunction, which can cause
measurement function, intelligence level was mental retardation.
improved to a certain extent.
Jia et al. 37 children Prospective Levetiracetam The rate of effectiveness and rate Levetiracetam showed good
(2010) with cerebral study monotherapy of adverse reaction were higher in therapeutic effect on cerebral
palsy the Levetiracetam monotherapy palsy infants with epilepsy. No
group. severe adverse reactions were
found.
Jiang 170 children Prospective Ganglioside and Gesell Developmental Scale scores Ganglioside and cerebrolysin
et al. with cerebral study cerebrolysin were better in the ganglioside indicated good effects on cerebral
(2010) palsy combined with and cerebrolysin combined with palsy.
rehabilitation rehabilitation training group than
training in the single drug + rehabilitation
training group.
Jia et al. 116 children Prospective Motor function Developmental quotient and overall Comprehensive rehabilitation, a key
(2011) with cerebral study training, massage, developmental quotient were method for cerebral palsy, elevated
palsy Chinese medicine apparently elevated in gross development quotient, gross
fumigation and motor, fine motor, adaptability, motor, fine motor, adaptability,
hyperbaric oxygen language and personal society language and personal society.
after treatment.

Note: MRI: Magnetic resonance imaging.

Key to treating cerebral palsy is how to simultaneously there has been little comparison or assessment of their clini-
improve mental retardation and pointed foot deformity. cal effects (Wen and Dong, 2009). Therefore, the combined
The methods to lessen foot spasm consist of exercise application of other methods with rehabilitation training is
therapy, physical therapy, kreotoxin, surgery, brace, wax needed to gain satisfactory effects.
therapy and shock wave. However, none is effective alone, Acupuncture has been shown to completely regulate
so combined therapy is needed. Apart from neurotrophic the body’s activities, improve movement, intelligence,
drugs, comprehensive rehabilitation training is performed emotion, physical and mental health (Liu et al., 2010;
in cerebral palsy children with mental retardation, includ- Zhang et al., 2010; Zhang and Wu, 2012). Xie et al.
ing exercise therapy, occupational therapy, speech therapy, (2012) verified that acupuncture at acupoints related to
psychotherapy, education and social rehabilitation. So far the motor area, sensory area, foot-motor-sensory area, and

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language area could noticeably increase cell viability in brain regions that might elucidate the mechanisms of acu-
the brain and promote the development of intelligence. puncture in treatment of spastic cerebral palsy. This study
Acupuncture at Quchi (LI11), Chize (LU5), Shousanli aims to provide quantitative data for acupuncture combined
(LI10), Zusanli (ST36), Sanyinjiao (SP6) and Naoqing with rehabilitation training in treatment of spastic cerebral
(Ex-LE16) can effectively relieve local muscle tension palsy. This trial will observe the immediate effects and
and improve abnormal posture. long-term effects of acupuncture on pointed foot of spastic
We suggest that acupuncture combined with reha- cerebral palsy patients and identify any therapeutic effect
bilitation training can effectively mitigate pointed foot of acupuncture.
deformities in children with spastic cerebral palsy and
improve the development of intelligence. This prospective, Methods/Design
randomized, controlled clinical trial will test the above Study design
hypothesis. Functional magnetic resonance imaging will This will be a prospective, randomized, controlled clinical
be utilized to observe any changes in acupuncture-activated trial (Figure 1).

81 infants of cerebral palsy

21 cases will be excluded according to inclusion

Exclude selection bias
and exclusion criteria.

60 cases of spastic cerebral palsy

Randomization and group assignment

Treatment group (n = 30): 6 months of Control group (n = 30): 6 months of

rehabilitation training after acupuncture rehabilitation training

Evaluation at 3 and 6 months of treatment

Primary outcomes: Gross Motor Func- Secondary outcomes: modified Ashworth Scale of Safety assessment: assessment
tion Measure, ankle range of motion, muscle spasticity, Fine Motor Function Measure, of adverse events
Gesell Developmental Scale and Gross Motor Function Classification System, and
surface electromyography functional magnetic resonance imaging

Data analysis

Figure 1: Flow chart of the trial.

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Ethical approval • Failure to follow the protocol or desire to drop out of the
A family member of each patient will be informed of the trial
study protocols, and will sign with their informed consent. • Poor compliance, investigators determine that the
The study will be performed in accordance with the guide- patient is not suitable for the trial
lines of the Declaration of Helsinki, formulated by the • Severe adverse reactions or critical security issues dur-
World Medical Association. ing the trial

Study participants Randomization

Sixty children with spastic cerebral palsy, hospitalized in the One day before treatment, sixty patients will be assigned
Out-Patient Clinic of Department of Pediatric Neurological a number. The starting point and order of sampling will
Rehabilitation, the First Hospital, Jilin University of China, be arbitrarily determined on a random number table. The
will be recruited to participate in this trial. number of samples will be selected from the random number
table. Sixty subjects will be equally and randomly assigned
Diagnostic criteria to treatment and control groups. Electronic medical advice
All subjects will meet cerebral palsy diagnostic criteria will be issued to the children.
(2015), formulated by Children’s Rehabilitation Profes- Li-li Wang, a study designer, will arrange and control
sional Committee of Chinese Association of Rehabilita- the entire test process. The assessors will not know the
tion Medicine, Rehabilitation Professional Committee protocols.
for Children with Cerebral Palsy of China Association of
Rehabilitation of Disabled Persons, and “China Cerebral Interventions
Palsy Rehabilitation Guide” Editorial Board. Subjects in the treatment group will receive conventional re-
habilitation training after acupuncture. Subjects in the control
(1) Prerequisites group will receive conventional rehabilitation training alone.
• Permanent central movement disorders
• Movement and posture abnormalities Acupuncture
• Reflex abnormality Head acupuncture contains Baihui (DU20), Sishencong
• Abnormal muscle tension and muscle strength (EX-HN1), motor area, foot-motor-sensory area, language
(2) Reference conditions area, Mental Tri-Points and Middle Line of Vertex (MS 5).
• Etiology of cerebral palsy For palsy, we will select the Yang meridian on limbs. Body
• Neuroimaging evidence (52–92%) acupuncture acupoints include Zusanli (ST36), Sanyinjiao
(SP6), Naoqing (Ex-LE16), Quchi (LI11), Chize (LU5),
Inclusion criteria Shousanli (LI10) and Hegu (LI4). Acupoints will be selected
Patients meeting all of the following criteria will be con- according to different symptoms: Tinggong (SI19), Yifeng
sidered for admission to the trial: (SJ17), head acupuncture at the vertigo-auditory zone or
• Spastic cerebral palsy posterior temporal line for hearing loss, Cuanzhu (BL2),
• Aged between 2 and 5 years old, boys and girls Chengqi (ST1), head acupuncture at the visual zone or upper-
• High risk factors for cerebral palsy lateral line of the occiput for abnormal vision. Acupuncture
• Informed consent of patients or their family members will be conducted once a day, six times a week. Head acu-
puncture: 30–60 minutes each; body acupuncture: 10–20
Exclusion criteria minutes each; 3 months as a course, totally two courses. All
Patients with any of the following criteria will be excluded disposable needles (0.3 mm × 25.0 mm) will be purchased
from this trial: from Guizhou Andi Medical Equipment Co., Ltd., Guiyang,
• Ulcer at the site of treatment Guizhou Province, China.
• Severe heart disease, arrhythmia or severe organ dys-
function, in the heart, lung, liver and kidney Conventional rehabilitation training
• Hemorrhagic disease, coagulation disorders Exercise therapy consists of Vojta therapy, Bobath neuro-
• Critical condition developmental therapy and Ueda therapy, once a day, 30
• Patients or family members refuse treatment minutes each, 6 days a week, for 6 months. Occupational
therapy addresses movement (control of upper limb muscle),
Withdrawal criteria sensation (normalization of sensory stimuli), and cognition;
Patients will be withdrawn from this trial if any of the once a day, 30 minutes each, 6 days a week. Speech therapy
conditions occurs: addresses dysarthria, pronunciation and cognition, once a

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day, 30 minutes each, 6 days a week. Physiotherapy includes card and follow-up record sheet, and then loaded into the
electrical nerve stimulation therapy and wax therapy, once computer for storage. The reasons why patients drop out or
a day, 30 minutes each, 6 days a week. Massage therapy have poor compliance will be recorded in the case report
comprises pressing, kneading and pricking, once a day, 30 form. We will as far as possible contact patients to gain
minutes each, 6 days a week. understanding and support, complete the evaluation, fill in
the follow-up record, record the time of the last treatment,
Follow-up and finally retain the electronic version of the data.
The sixty patients will have their own follow-up card, and
will be followed up by telephone at 6 months after treat- Outcome measures
ment. Follow-up results will be recorded on the follow-up Trial outcome measurement schedule is given in Table 2.

Table 2: Trial outcome measurement and evaluation time

Baseline (0 day) 3 months of treatment 6 months of treatment
Demographic data X
Inclusion criteria X
Exclusion criteria X
Informed consent X
Gross Motor Function Measure X X
Ankle range of motion X X
Surface electromyography X X
Gesell Developmental Scale X X
Modified Ashworth Scale of muscle spasticity X X
Gross Motor Function Classification System X X
Fine Motor Function Measure X X
Functional magnetic resonance imaging X X
Adverse reaction X X

Primary outcomes until adverse events completely disappeared. Inves-

• Gross Motor Function Measure (Badia et al., 2016) tigators must determine whether adverse events are
• Ankle range of motion related to acupuncture and rehabilitation training, and
• Gesell Developmental Scale (Dukes and Buttery, 1982) provide evidence to support this judgment
• Surface electromyography
Data collection and management
Secondary outcomes Two researchers will separately copy the required informa-
• Modified Ashworth Scale of muscle spasticity (Mishra tion from the electronic medical record and fill in a table,
and Ganes, 2014) once a month. After copying, the data will be dated and
• Fine Motor Function Measure (Kolind et al., 2015) loaded into the computer for storage. The investigator,
• Gross Motor Function Classification System (Badia et who is in charge of group assignment, will create a table to
al., 2016) summarize the data of every stage. After the follow-up, the
• Functional magnetic resonance imaging to observe the data from the two tables will be checked. The blind codes
activation of different brain regions after acupuncture will be preserved, and the database will be locked. After
locking, the data file cannot be changed and the database
Safety assessment will be saved for future reference. In the first unblinding, the
• Data affecting safety assessment: recorded by an in- treatment and control groups will be named as A and B, and
dependent physician, and assessed by two members of the database will be analyzed by biostatistics professionals.
staff who do not participate in the trial Afterwards, the second unblinding will be conducted.
• Adverse reactions: convulsion, acupuncture syncope,
subcutaneous tumor, hemorrhage, infection, low-grade Possible bias and control
fever and fatigue Bias
• Adverse events: investigators should observe and • Diagnostic bias: To achieve uniform diagnostic criteria
record the turnover of all adverse events by follow-up during inclusion criteria

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• Admission rate bias: Tendency to choose hospitalized tionally recognized indicators to judge abnormal posture
children to reduce the loss of follow-up and improve and intelligence in cerebral palsy patients. The changes in
compliance ankle range of motion will be observed to further identify
• Nonresponse bias: Study subjects do not answer the the improvement in pointed foot deformity. In this trial,
survey content as required or conceal the truth acupuncture combined with rehabilitation training will be
• Measurement bias: A certain error will be induced by applied to treat spastic cerebral palsy in infants to gain a
subjective factors of different researcher’s measure- better therapeutic effect. Functional magnetic resonance
ment imaging will be employed to observe the activation of motor
• Confounding bias: Sex and age are common confound- area and language area after acupuncture and rehabilitation
ing factors training. This may point to the mechanism of action of
acupuncture with rehabilitation training on cerebral palsy
Bias control measures
in infants.
• Researchers receive uniform training
• Strict inclusion and exclusion criteria
Trial status
• Ensure the independence of samples
• Eliminate or reduce additional damage to patients to Ongoing and recruiting at the time of submission.
aid good compliance
• Reduce the withdrawal of cases, children who quit
Conflicts of interest
should be followed up
None declared.
• More than one member of staff could assess each Author contributions
patient. The same member(s) assess the same patient at LLW designed and participated in this trial, and obtained
each stage to prevent measurement bias final test data set. LD assessed indexes. LS collected and
• Independent variables in multivariate analysis will be analyzed statistical data. HYD retrieved references and wrote
discussed, such as cause, course and sex the paper. FYJ served as a principle investigator. All authors
• Reduce data loss. Data analysis will also be performed aproved the final version of the paper for publication.
in patients who had quit the treatment Plagiarism check
This paper was screened twice using CrossCheck to verify
Statistical analysis originality before publication.
Data will be analyzed with SPSS 15.0 software (SPSS, Chi- Peer review
cago, IL, USA). First, we will apply a statistical description This paper was double-blinded and stringently reviewed by
of the data. Measurement data that obey normal distribution international expert reviewers.
will be expressed as mean, standard deviation, minimum
value and maximum value. Data that do not obey normal
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